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Efficacy and Safety of Tildrakizumab Compared to Placebo in Subjects With Active Psoriatic Arthritis I (INSPIRE 1)

Primary Purpose

Active Psoriatic Arthritis

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
TILD
matching placebo injections
Sponsored by
Sun Pharmaceutical Industries Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Active Psoriatic Arthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Subject has provided written informed consent.
  2. Subject is ≥ 18 years of age at time of Screening.
  3. RF and anti-CCP Ab negative.
  4. Subjects must have prior exposure to anti-TNF agent(s) use for the treatment of PsO or PsA.

Exclusion Criteria:

  1. Subject has a planned surgical intervention between Baseline and the Week 24 evaluation for a pretreatment condition.
  2. Subject has an active infection or history of infections as follows:

    • any active infection for which systemic anti-infectives were used within 28 days prior to first IMP dose, with the last dose having been received within 7 days of Screening,
    • a serious infection, defined as requiring hospitalization or IV anti-infectives within 8 weeks prior to the first IMP dose, with the last dose having been received within 7 days of Screening,
    • recurrent or chronic infections, e.g., chronic pyelonephritis, chronic osteomyelitis, bronchiectasis, or other active infection that, in the opinion of the Investigator, might cause this study to be detrimental to the subject.
  3. Subject has a known history of infection with hepatitis B, hepatitis C, or human immunodeficiency virus.
  4. Subject had myocardial infarction, unstable angina pectoris, or ischemic stroke within the past 6 months prior to the first IMP dose.
  5. Subject has any active malignancy, including evidence of cutaneous basal or squamous cell carcinoma or melanoma.
  6. Subject has a history of malignancy within 5 years from the time of Screening EXCEPT treated and considered cured cutaneous basal or squamous cell carcinoma, in situ cervical carcinoma, OR in situ breast ductal carcinoma.
  7. Subjects with a history of alcohol or drug abuse in the previous 2 years.
  8. Female subjects of childbearing potential who do not agree to abstain from heterosexual activity or practice a dual method of contraception, for example, a combination of the following: (1) oral contraceptive, depo progesterone, or intrauterine device; and (2) a barrier method (condom or diaphragm). Male subjects with female partners of childbearing potential who are not using birth control as described above must use a barrier method of contraception (e.g., condom) if not surgically sterile (i.e., vasectomy). Contraceptive methods must be practiced upon entering the study and through 17 weeks after the last dose of IMP. If a subject discontinues prematurely, the contraceptive method must be practiced for 17 weeks following final administration of IMP. A FSH test should be performed to confirm menopause for those women with no menses for less than 1 year.
  9. Subject currently enrolled in another investigational device/procedure or drug study, or Baseline of this study is less than 30 days or 5 half-lives (whichever is longer) since ending another investigational device/procedure or drug study(s), or receiving other investigational agent(s).
  10. Subject previously has been enrolled (randomized) in this study.
  11. Subject has any kind of disorder that, in the opinion of the Investigator, may compromise the ability of the subject to give written informed consent and/or to comply with all required study procedures.
  12. Donation or loss of 400 mL or more of blood within 8 weeks before dosing.
  13. Subjects who have been placed in an institution on official or judicial orders.
  14. Subjects who are related to or dependent on the Investigator, Sponsor, or study site such that a conflict of interest could arise.

Sites / Locations

  • Sunpharma Site no 47Recruiting
  • Sunpharma Site no 42Recruiting
  • Sunpharma Site no 29Recruiting
  • Sunpharma Site no 31Recruiting
  • Sunpharma Site no 30Recruiting
  • Sunpharma Site no 43
  • Sunpharma Site no 35Recruiting
  • Sunpharma Site no 48Recruiting
  • Sunpharma site no. 17Recruiting
  • Sunpharma site no. 15Recruiting
  • Sunpharma Site no 40Recruiting
  • Sunpharma Site no 36Recruiting
  • Sunpharma Site no 32
  • Sunpharma site no. 21Recruiting
  • Sunpharma site no. 02Recruiting
  • Sunpharma Site no 39
  • Sunpharma Site no 55Recruiting
  • Sunpharma Site no. 75Recruiting
  • Sunpharma site no. 19Recruiting
  • Sunpharma site no. 05Recruiting
  • Sunpharma Site no. 76Recruiting
  • SunPharma Site no 22Recruiting
  • Sunpharma Site no 46Recruiting
  • Sunpharma Site no. 122
  • Sunpharma Site no 41Recruiting
  • Sunpharma Site no 54Recruiting
  • Sunpharma Site no 38Recruiting
  • Sunpharma Site no 37Recruiting
  • Sunpharma site no. 20Recruiting
  • Sunpharma Site no 26Recruiting
  • Sunpharma site no. 07Recruiting
  • Sunpharma site no. 10
  • Sunpharma Site no 45Recruiting
  • Sunpharma site no. 14Recruiting
  • Sunpharma Site no. 123
  • Sunpharma Site no 53Recruiting
  • Sunpharma Site no 27Recruiting
  • Sunpharma Site no 44Recruiting
  • Sunpharma site no. 09
  • Sunpharma Site no 52Recruiting
  • Sunpharma Site no. 73Recruiting
  • Sunpharma Site no 56Recruiting
  • Sunpharma Site no. 119Recruiting
  • Sunpharma Site no 33Recruiting
  • Sunpharma site no. 18
  • Sunpharma site no. 11Recruiting
  • Sunpharma Site no. 124
  • Sunpharma site no. 25
  • Sunpharma Site no 34Recruiting
  • Sunpharma Site no 50Recruiting
  • Sunpharma site no. 13
  • Sunpharma Site no 49Recruiting
  • Sunpharma site no. 06
  • Sunpharma site no. 08Recruiting
  • Sunpharma site no. 04Recruiting
  • Sunpharma Site no 28Recruiting
  • Sunpharma Site no. 74Recruiting
  • Sunpharma site no. 03
  • Sunpharma site no. 16Recruiting
  • Sunpharma site no. 01Recruiting
  • Sunpharma Site no. 121
  • Sunpharma site no. 12
  • Sunpharma Site no. 81Recruiting
  • Sunpharma Site no. 84
  • Sunpharma Site no 68Recruiting
  • Sunpharma site no. 24Recruiting
  • Sunpharma Site no 67
  • Sunpharma Site no. 82Recruiting
  • Sunpharma Site no. 83Recruiting
  • Sunpharma Site no. 97
  • Sunpharma site 98
  • Sun pharma site 99Recruiting
  • Sunpharma Site no. 100
  • Sunpharma Site no. 101
  • Sunpharma Site no. 96Recruiting
  • Sunpharma Site no. 125
  • Sunpharma Site no. 85Recruiting
  • Sunpharma site no. 102
  • Sunpharma Site no. 87Recruiting
  • Sunpharma Site no. 86Recruiting
  • Sunpharma Site no. 89Recruiting
  • Sunpharma Site no. 91Recruiting
  • Sunpharma Site no. 90Recruiting
  • Sunpharma Site no. 103Recruiting
  • Sunpharma Site no. 120
  • Sunpharma Site no. 104
  • Sunpharma Site no. 126
  • Sunpharma Site no 69Recruiting
  • Sunpharma Site no 72Recruiting
  • Sunpharma Site no 71Recruiting
  • Sunpharma Site no 70Recruiting
  • Sunpharma Site no. 95Recruiting
  • Sunpharma Site no. 93Recruiting
  • Sunpharma Site no. 110Recruiting
  • Sunpharma Site no. 94Recruiting
  • Sunpharma Site no. 109
  • Sunpharma Site no. 107Recruiting
  • Sunpharma Site no. 106Recruiting
  • Sunpharma Site no. 92Recruiting
  • Sunpharma Site no. 108Recruiting
  • Sunpharma Site no. 111Recruiting
  • Sunpharma Site no. 88Recruiting
  • Sunpharma Site no. 113Recruiting
  • Sunpharma Site no. 114
  • Sunpharma Site no. 112Recruiting
  • Sunpharma Site no. 115
  • Sunpharma Site no 57Recruiting
  • SunPharma Site No 23
  • Sunpharma Site no. 118
  • Sunpharma Site no 58Recruiting
  • Sunpharma Site no. 78Recruiting
  • Sunpharma Site no. 116Recruiting
  • Sunpharma Site no. 77Recruiting
  • Sunpharma Site no. 117Recruiting
  • Sunpharma Site no 59Recruiting
  • Sunpharma Site no 51
  • Sunpharma Site no 65Recruiting
  • Sunpharma Site no 63Recruiting
  • Sunpharma Site no. 79Recruiting
  • Sunpharma Site no. 80
  • Sunpharma Site no 62Recruiting
  • Sunpharma Site no 61Recruiting
  • Sunpharma Site no 60Recruiting
  • Sunpharma Site no 64Recruiting
  • Sunpharma Site no 66Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm A

Arm B

Arm Description

Outcomes

Primary Outcome Measures

The proportion of subjects who achieve American College of Rheumatology [ACR20]
the proportion of subjects achieving a 20% reduction from Baseline in response criteria

Secondary Outcome Measures

The proportion of subjects achieving American College of Rheumatology [ACR50]
the proportion of subjects achieving a 50% reduction from Baseline in response criteria
The proportion of subjects achieving American College of Rheumatology [ACR70]
the proportion of subjects achieving a 70% reduction from Baseline in response criteria
The proportion of subjects achieving Psoriasis Area and Severity Index 75 response among subjects with Body surface area ≥3% at baseline
The change from Baseline in the van der Heijde modified total Sharp score
The change from Baseline in the van der Heijde modified total Sharp score
Change from Baseline in American College of Rheumatology Response Criteria Components Score
Tender Joint Count (68), Swollen Joint Count (66), Physician's Global Assessment of Arthritis (Visual Analog Scale, 0-100), Patient's Global Assessment of Arthritis (Visual Analog Scale, 0-100), Patient's Assessment of Arthritis Pain (Visual Analog Scale, 0-100), C-reactive protein levels, Erythrocyte sedimentation rate levels
change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index
change from Baseline in Leeds Enthesitis Index
The change from Baseline in Leeds Dactylitis Index
The proportion of subjects who achieve a disease activity score-C-reactive protein < 3.2
The change from Baseline in van der Heijde modified Sharp sub-scores (erosion score and joint space narrowing score)
The proportion of subjects with the Change in van der Heijde modified total Sharp score <0 and < 0.5
The proportion of subjects with active Psoriasis and Body surface area ≥3%
with: Psoriasis Area and Severity Index 90 and Psoriasis Area and Severity Index 100
The change from Baseline in subjects with active Psoriasis and Body surface area ≥ 3% ("those with involvement of nails" )
Physician Global Assessment-Psoriasis and nail psoriasis severity index
The proportion of subjects achieving American College of Rheumatology [ACR20, ACR50 and ACR70]
the proportion of subjects achieving a 20/50/70% reduction from Baseline in response criteria
The change from Baseline in American College of Rheumatology Response Criteria Components Score
Tender Joint Count (68), Swollen Joint Count (66), Physician's Global Assessment of Arthritis (Visual Analog Scale, 0-100), Patient's Global Assessment of Arthritis (Visual Analog Scale, 0-100), Patient's Assessment of Arthritis Pain (Visual Analog Scale, 0-100), C-reactive protein levels, Erythrocyte sedimentation rate levels
The change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index
The change from Baseline
Leeds Enthesitis Index, Leeds Dactylitis Index, Health Assessment Questionnaire Disability Index Score
The proportion of subjects who achieve a Disease Activity Score(28 [joints]-C-reactive protein) < 3.2
The change from Baseline in van der Heijde modified total Sharp score
The change from Baseline in van der Heijde modified Sharp sub-scores (erosion score and joint space narrowing score)
The proportion of subjects with the change in van der Heijde modified total Sharp score <0 and < 0.5
In subjects with active Psoriasis and Body surface area ≥3%, the proportion of subjects
Psoriasis Area and Severity Index 75, Psoriasis Area and Severity Index 90 and Psoriasis Area and Severity Index 100
In subjects with active Psoriasis and Body surface area ≥3% those with involvement of nails , the change from Baseline in nail psoriasis severity index
In subjects with active Psoriasis and Body surface area ≥3%, the change from Baseline in Physician Global Assessment-Psoriasis
Change from baseline in health assessment questionnaire - disability index (HAQ-DI) score
The change from Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components
Physical Functioning Domain, Role-Physical Domain, Role-Emotional Domain, Bodily Pain Domain, Mental Health Domain, General Health Domain, Vitality Domain, Social Functioning Domain, Physical Component Summary Score, Mental Component Summary Score
The change from Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue Scores

Full Information

First Posted
March 13, 2020
Last Updated
September 5, 2023
Sponsor
Sun Pharmaceutical Industries Limited
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1. Study Identification

Unique Protocol Identification Number
NCT04314544
Brief Title
Efficacy and Safety of Tildrakizumab Compared to Placebo in Subjects With Active Psoriatic Arthritis I (INSPIRE 1)
Official Title
A Phase III, Randomized, Double-Blind, Single-Dose, Placebo-Controlled Study to Demonstrate the Efficacy and Safety of Tildrakizumab in Subjects With Active Psoriatic Arthritis I (INSPIRE 1)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
March 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sun Pharmaceutical Industries Limited

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a multicenter Phase III, Randomized, Double-Blind, Single-Dose, Placebo-Controlled Study to Demonstrate the Efficacy and Safety of tildrakizumab in Subjects with Active Psoriatic Arthritis I (INSPIRE 1)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Active Psoriatic Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
472 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm A
Arm Type
Experimental
Arm Title
Arm B
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
TILD
Intervention Description
one 1 mL injection of study medication
Intervention Type
Drug
Intervention Name(s)
matching placebo injections
Intervention Description
one 1 mL injection of placebo
Primary Outcome Measure Information:
Title
The proportion of subjects who achieve American College of Rheumatology [ACR20]
Description
the proportion of subjects achieving a 20% reduction from Baseline in response criteria
Time Frame
at week 24
Secondary Outcome Measure Information:
Title
The proportion of subjects achieving American College of Rheumatology [ACR50]
Description
the proportion of subjects achieving a 50% reduction from Baseline in response criteria
Time Frame
at Week 24
Title
The proportion of subjects achieving American College of Rheumatology [ACR70]
Description
the proportion of subjects achieving a 70% reduction from Baseline in response criteria
Time Frame
at Week 24
Title
The proportion of subjects achieving Psoriasis Area and Severity Index 75 response among subjects with Body surface area ≥3% at baseline
Time Frame
at Weeks 24
Title
The change from Baseline in the van der Heijde modified total Sharp score
Time Frame
at Week 24
Title
The change from Baseline in the van der Heijde modified total Sharp score
Time Frame
at Week 16
Title
Change from Baseline in American College of Rheumatology Response Criteria Components Score
Description
Tender Joint Count (68), Swollen Joint Count (66), Physician's Global Assessment of Arthritis (Visual Analog Scale, 0-100), Patient's Global Assessment of Arthritis (Visual Analog Scale, 0-100), Patient's Assessment of Arthritis Pain (Visual Analog Scale, 0-100), C-reactive protein levels, Erythrocyte sedimentation rate levels
Time Frame
at Week 24
Title
change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index
Time Frame
at Week 24
Title
change from Baseline in Leeds Enthesitis Index
Time Frame
at Week 24
Title
The change from Baseline in Leeds Dactylitis Index
Time Frame
at Week 24
Title
The proportion of subjects who achieve a disease activity score-C-reactive protein < 3.2
Time Frame
at Week 24
Title
The change from Baseline in van der Heijde modified Sharp sub-scores (erosion score and joint space narrowing score)
Time Frame
at Week 24
Title
The proportion of subjects with the Change in van der Heijde modified total Sharp score <0 and < 0.5
Time Frame
at Week 24.
Title
The proportion of subjects with active Psoriasis and Body surface area ≥3%
Description
with: Psoriasis Area and Severity Index 90 and Psoriasis Area and Severity Index 100
Time Frame
at Week 24
Title
The change from Baseline in subjects with active Psoriasis and Body surface area ≥ 3% ("those with involvement of nails" )
Description
Physician Global Assessment-Psoriasis and nail psoriasis severity index
Time Frame
at Week 24
Title
The proportion of subjects achieving American College of Rheumatology [ACR20, ACR50 and ACR70]
Description
the proportion of subjects achieving a 20/50/70% reduction from Baseline in response criteria
Time Frame
at week 52
Title
The change from Baseline in American College of Rheumatology Response Criteria Components Score
Description
Tender Joint Count (68), Swollen Joint Count (66), Physician's Global Assessment of Arthritis (Visual Analog Scale, 0-100), Patient's Global Assessment of Arthritis (Visual Analog Scale, 0-100), Patient's Assessment of Arthritis Pain (Visual Analog Scale, 0-100), C-reactive protein levels, Erythrocyte sedimentation rate levels
Time Frame
at Week 52
Title
The change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index
Time Frame
at Week 52
Title
The change from Baseline
Description
Leeds Enthesitis Index, Leeds Dactylitis Index, Health Assessment Questionnaire Disability Index Score
Time Frame
at Week 52
Title
The proportion of subjects who achieve a Disease Activity Score(28 [joints]-C-reactive protein) < 3.2
Time Frame
at Week 52
Title
The change from Baseline in van der Heijde modified total Sharp score
Time Frame
at Week 52
Title
The change from Baseline in van der Heijde modified Sharp sub-scores (erosion score and joint space narrowing score)
Time Frame
at Week 52
Title
The proportion of subjects with the change in van der Heijde modified total Sharp score <0 and < 0.5
Time Frame
at Week 52
Title
In subjects with active Psoriasis and Body surface area ≥3%, the proportion of subjects
Description
Psoriasis Area and Severity Index 75, Psoriasis Area and Severity Index 90 and Psoriasis Area and Severity Index 100
Time Frame
at Week 52
Title
In subjects with active Psoriasis and Body surface area ≥3% those with involvement of nails , the change from Baseline in nail psoriasis severity index
Time Frame
at Week 52
Title
In subjects with active Psoriasis and Body surface area ≥3%, the change from Baseline in Physician Global Assessment-Psoriasis
Time Frame
at Week 52
Title
Change from baseline in health assessment questionnaire - disability index (HAQ-DI) score
Time Frame
at Week 24
Title
The change from Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components
Description
Physical Functioning Domain, Role-Physical Domain, Role-Emotional Domain, Bodily Pain Domain, Mental Health Domain, General Health Domain, Vitality Domain, Social Functioning Domain, Physical Component Summary Score, Mental Component Summary Score
Time Frame
Weeks 24 and 52
Title
The change from Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue Scores
Time Frame
at Week 24
Other Pre-specified Outcome Measures:
Title
The proportion of subjects achieving American College of Rheumatology [ACR20]
Description
the proportion of subjects achieving a 20% reduction from Baseline in response criteria
Time Frame
Weeks 24 and 52
Title
The proportion of subjects achieving American College of Rheumatology [ACR50]
Description
the proportion of subjects achieving a 50% reduction from Baseline in response criteria
Time Frame
Weeks 24 and 52
Title
The proportion of subjects achieving American College of Rheumatology [ACR70]
Description
the proportion of subjects achieving a 70% reduction from Baseline in response criteria
Time Frame
Weeks 24 and 52
Title
The change from Baseline in American College of Rheumatology Response Criteria Components Score
Description
Tender Joint Count (68), Swollen Joint Count (66), Physician's Global Assessment of Arthritis (Visual Analog Scale, 0-100), Patient's Global Assessment of Arthritis (Visual Analog Scale, 0-100), Patient's Assessment of Arthritis Pain (Visual Analog Scale, 0-100), C-reactive protein levels and Erythrocyte sedimentation rate levels
Time Frame
Weeks 24 and 52
Title
The change from Baseline
Description
Leeds Enthesitis Index, Leeds Dactylitis Index, Bath Ankylosing Spondylitis Disease Activity Index and Health Assessment Questionnaire Disability Index score
Time Frame
Weeks 24 and 52
Title
The proportion of subjects who achieve a Disease activity score-C-reactive protein < 3.2
Time Frame
Weeks 24 and 52
Title
The proportion of subjects with active Psoriasis and Body surface area ≥ 3%
Description
Psoriasis Area and Severity Index 75, Psoriasis Area and Severity Index 90 and Psoriasis Area and Severity Index 100
Time Frame
Weeks 24 and 52
Title
The change from Baseline in the levels of "Metabolic Biomarkers"
Time Frame
at Week 24
Title
the change from baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA)
Time Frame
at Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 and Week 52
Title
proportion of subjects who achieve a response based on Modified Psoriatic Arthritis Responder Criteria (PsARC)
Time Frame
at Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 and Week 52.
Title
change from baseline in Work Productivity and Activity Impairment Questionnaire Scores
Time Frame
at Week 12,16 24, 48 and 52
Title
change from baseline in Psoriatic Arthritis Disease Activity Score (PASDAS)
Time Frame
at Week 8,16, 24 and 52.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject has provided written informed consent. Subject is ≥ 18 years of age at time of Screening. RF and anti-CCP Ab negative. Subjects must have prior exposure to anti-TNF agent(s) use for the treatment of PsO or PsA. Exclusion Criteria: Subject has a planned surgical intervention between Baseline and the Week 24 evaluation for a pretreatment condition. Subject has an active infection or history of infections as follows: any active infection for which systemic anti-infectives were used within 28 days prior to first IMP dose, with the last dose having been received within 7 days of Screening, a serious infection, defined as requiring hospitalization or IV anti-infectives within 8 weeks prior to the first IMP dose, with the last dose having been received within 7 days of Screening, recurrent or chronic infections, e.g., chronic pyelonephritis, chronic osteomyelitis, bronchiectasis, or other active infection that, in the opinion of the Investigator, might cause this study to be detrimental to the subject. Subject has a known history of infection with hepatitis B, hepatitis C, or human immunodeficiency virus. Subject had myocardial infarction, unstable angina pectoris, or ischemic stroke within the past 6 months prior to the first IMP dose. Subject has any active malignancy, including evidence of cutaneous basal or squamous cell carcinoma or melanoma. Subject has a history of malignancy within 5 years from the time of Screening EXCEPT treated and considered cured cutaneous basal or squamous cell carcinoma, in situ cervical carcinoma, OR in situ breast ductal carcinoma. Subjects with a history of alcohol or drug abuse in the previous 2 years. Female subjects of childbearing potential who do not agree to abstain from heterosexual activity or practice a dual method of contraception, for example, a combination of the following: (1) oral contraceptive, depo progesterone, or intrauterine device; and (2) a barrier method (condom or diaphragm). Male subjects with female partners of childbearing potential who are not using birth control as described above must use a barrier method of contraception (e.g., condom) if not surgically sterile (i.e., vasectomy). Contraceptive methods must be practiced upon entering the study and through 17 weeks after the last dose of IMP. If a subject discontinues prematurely, the contraceptive method must be practiced for 17 weeks following final administration of IMP. A FSH test should be performed to confirm menopause for those women with no menses for less than 1 year. Subject currently enrolled in another investigational device/procedure or drug study, or Baseline of this study is less than 30 days or 5 half-lives (whichever is longer) since ending another investigational device/procedure or drug study(s), or receiving other investigational agent(s). Subject previously has been enrolled (randomized) in this study. Subject has any kind of disorder that, in the opinion of the Investigator, may compromise the ability of the subject to give written informed consent and/or to comply with all required study procedures. Donation or loss of 400 mL or more of blood within 8 weeks before dosing. Subjects who have been placed in an institution on official or judicial orders. Subjects who are related to or dependent on the Investigator, Sponsor, or study site such that a conflict of interest could arise.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Head, Clinical development
Phone
91 2266455645
Ext
5689
Email
Clinical.Trial@sunpharma.com
Facility Information:
Facility Name
Sunpharma Site no 47
City
Anniston
State/Province
Alabama
ZIP/Postal Code
36207
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vishala Chindalore, M.D./CCRP
Phone
256-236-0055
Email
vchindalore@pinnacletrials.com
Facility Name
Sunpharma Site no 42
City
Dothan
State/Province
Alabama
ZIP/Postal Code
36305
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Edmond Lacour, M.D.
Phone
334-699-1632
Email
e.laco@secclinicalresearch.com
Facility Name
Sunpharma Site no 29
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85297
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Kreutz, M.D.
Phone
480-588-6253
Email
kreutz.research@azarthritis.com
Facility Name
Sunpharma Site no 31
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Areena Swarup, M.D.
Phone
480-321-8581
Email
swarup.research@azarthritis.com
Facility Name
Sunpharma Site no 30
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Saima Chohan, M.D.
Phone
480-626-6651
Email
chohan.research@azarthritis.com
Facility Name
Sunpharma Site no 43
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Individual Site Status
Withdrawn
Facility Name
Sunpharma Site no 35
City
Covina
State/Province
California
ZIP/Postal Code
91722
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samy Metyas, M.D., MSc., FACR, FACP
Phone
626-869-5730
Email
drmetyas@gmail.com
Facility Name
Sunpharma Site no 48
City
Encino
State/Province
California
ZIP/Postal Code
91436
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joseph Raoof, M.D.
Phone
818-788-5060
Email
joseph@drraoof.com
Facility Name
Sunpharma site no. 17
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vivian T Laquer, M.D
Phone
714-531-2966
Email
vivian.laquer@gmail.com
Facility Name
Sunpharma site no. 15
City
Thousand Oaks
State/Province
California
ZIP/Postal Code
91320
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Navid Ezra, M.D.
Phone
805-298-7021
Email
navid.ezra@gmail.com
Facility Name
Sunpharma Site no 40
City
Denver
State/Province
Colorado
ZIP/Postal Code
80230
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher Antolini, M.D.
Phone
303-394-2828
Email
rantolini@dacdenver.com
Facility Name
Sunpharma Site no 36
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80528
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Thakor, M.D.
Phone
970-440-2121
Email
mthakor@tektonresearch.com
Facility Name
Sunpharma Site no 32
City
Bridgeport
State/Province
Connecticut
ZIP/Postal Code
06606
Country
United States
Individual Site Status
Withdrawn
Facility Name
Sunpharma site no. 21
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Levin, M.D.
Phone
727-466-0078
Ext
225
Email
rlevin@crwf.com
Facility Name
Sunpharma site no. 02
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carlos A Sesin, M.D.
Phone
305-456-9062
Email
c.sesin@sweethoperesearch.com
Facility Name
Sunpharma Site no 39
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Individual Site Status
Withdrawn
Facility Name
Sunpharma Site no 55
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34741
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karamali Bandealy
Phone
407-750-5300
Email
KBandealy@vidaclinicalresearch.com
Facility Name
Sunpharma Site no. 75
City
Margate
State/Province
Florida
ZIP/Postal Code
33063
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jigar Shah
Phone
954-669-1052
Email
jshah@lifeclinicaltrials.com
Facility Name
Sunpharma site no. 19
City
Miami
State/Province
Florida
ZIP/Postal Code
33135
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ricardo J Garcia-Alemany, M.D.
Phone
305-631-6704
Email
rgarciamd@suncoastresearch.com
Facility Name
Sunpharma site no. 05
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Farrukh Zaidi, M.D.
Phone
727-849-4131
Email
fzaidi@suncoastclinicalresearch.com
Facility Name
Sunpharma Site no. 76
City
Ocoee
State/Province
Florida
ZIP/Postal Code
34761
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mariangeli Arroyo-Avila
Phone
732-800-4415
Email
marroyo.acro@gmail.com
Facility Name
SunPharma Site no 22
City
Tamarac
State/Province
Florida
ZIP/Postal Code
33321
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Steven Kimmel, M.D.
Phone
954-545-8400
Email
wbrakimmel@gmail.com
Facility Name
Sunpharma Site no 46
City
Gainesville
State/Province
Georgia
ZIP/Postal Code
30501
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marta T Bognar, M.D.
Phone
770-531-3711
Email
mtb@articularishealthcare.com
Facility Name
Sunpharma Site no. 122
City
Glenview
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Sunpharma Site no 41
City
Oak Brook
State/Province
Illinois
ZIP/Postal Code
60523
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angela Crowley, M.D.
Phone
630-491-1900
Email
acrowley@affinityhealthcorp.com
Facility Name
Sunpharma Site no 54
City
Orland Park
State/Province
Illinois
ZIP/Postal Code
60467
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cory Conniff
Phone
847-599-2492
Email
CCONNIFF@CISRESEARCH.COM
Facility Name
Sunpharma Site no 38
City
Schaumburg
State/Province
Illinois
ZIP/Postal Code
60185
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kamran Chaudhary, M.D.
Phone
630-339-5300
Email
kchaudhary@clsresearch.com
Facility Name
Sunpharma Site no 37
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60076
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Hozman, M.D., S. C
Phone
847-673-8473
Email
rhozman@cisresearch.com
Facility Name
Sunpharma site no. 20
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67207
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shadi H Shahouri, M.D., FACR
Phone
316-689-6683
Email
shadi.shahouri@amrllc.com
Facility Name
Sunpharma Site no 26
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70605
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Enrique Mendez, M.D.
Phone
337-312-8619
Email
emendezmd@accurateclinicalresearch.com
Facility Name
Sunpharma site no. 07
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charles A Birbara, M.D.
Phone
508-755-0201
Email
cabirbara@aol.com
Facility Name
Sunpharma site no. 10
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48910
Country
United States
Individual Site Status
Withdrawn
Facility Name
Sunpharma Site no 45
City
Eagan
State/Province
Minnesota
ZIP/Postal Code
55121
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Ridley, M.D.
Phone
651-361-8659
Email
dridley@sprdrem.com
Facility Name
Sunpharma site no. 14
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65810
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David G True, D.O., FACR
Phone
417-883-7889
Email
dtrue@clinvest.com
Facility Name
Sunpharma Site no. 123
City
Webster Groves
State/Province
Missouri
ZIP/Postal Code
63119
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Sunpharma Site no 53
City
Kalispell
State/Province
Montana
ZIP/Postal Code
59901
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roger Diegel
Phone
406-755-1460
Email
jwyatt@krmc.org
Facility Name
Sunpharma Site no 27
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68516
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melvin Churchill, M.D.
Phone
402-420-3433
Email
Melvin.Churchill@nebraskaarthritis.com
Facility Name
Sunpharma Site no 44
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adrienne Hollander, M.D.
Phone
856-424-5005
Email
drhollandertrials@arbda.com
Facility Name
Sunpharma site no. 09
City
Rochester
State/Province
New York
ZIP/Postal Code
14623
Country
United States
Individual Site Status
Withdrawn
Facility Name
Sunpharma Site no 52
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alireza Nami
Phone
203-374-9816
Email
anami@jmmcri.com
Facility Name
Sunpharma Site no. 73
City
Leland
State/Province
North Carolina
ZIP/Postal Code
28451
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Snow, M.D.
Phone
910-726-1806
Email
dsnow@interspond.com
Facility Name
Sunpharma Site no 56
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
George Ronald
Phone
910-815-6108
Email
RGeorge@wilmingtonhealth.com
Facility Name
Sunpharma Site no. 119
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ronald George
Phone
910-815-6108
Email
RGeorge@wilmingtonhealth.com
Facility Name
Sunpharma Site no 33
City
Minot
State/Province
North Dakota
ZIP/Postal Code
58701
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erdal Diri, M.D.
Phone
701-857-2510
Email
erdaldiri@yahoo.com
Facility Name
Sunpharma site no. 18
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Individual Site Status
Suspended
Facility Name
Sunpharma site no. 11
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isam A Diab, M.D.
Phone
440-826-0742
Email
IDIABMD@GMAIL.COM
Facility Name
Sunpharma Site no. 124
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Sunpharma site no. 25
City
Wyomissing
State/Province
Pennsylvania
ZIP/Postal Code
19610
Country
United States
Individual Site Status
Terminated
Facility Name
Sunpharma Site no 34
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29601
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeffrey Lawson, M.D.
Phone
864-527-2307
Email
lawson@piedmontarthritis.com
Facility Name
Sunpharma Site no 50
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul Pickrell, M.D.
Phone
512-388-5717
Email
ppickrell@tektonresearch.com
Facility Name
Sunpharma site no. 13
City
Baytown
State/Province
Texas
ZIP/Postal Code
77521
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Sunpharma Site no 49
City
Grapevine
State/Province
Texas
ZIP/Postal Code
76051
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dhiman Basu, M.D./F.A.C.R
Phone
972-299-8399
Email
dhimanbasu@pccrsolutions.com
Facility Name
Sunpharma site no. 06
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Individual Site Status
Withdrawn
Facility Name
Sunpharma site no. 08
City
Houston
State/Province
Texas
ZIP/Postal Code
77084
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amber Khan, M.D.
Phone
832-672-7973
Email
akhanmd@accurateclinicalresearch.com
Facility Name
Sunpharma site no. 04
City
League City
State/Province
Texas
ZIP/Postal Code
77573
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michelle Eisenberg, M.D.
Phone
210-762-6579
Email
meisenbergmd@accurateclinicalresearch.com
Facility Name
Sunpharma Site no 28
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79410
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jitendra Vasandani, M.D.
Phone
806-993-1040
Email
jitendra.vasandani@yahoo.com
Facility Name
Sunpharma Site no. 74
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75150
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Atul Singhal, M.D.
Phone
972-288-2600
Email
asinghal@swrr.net
Facility Name
Sunpharma site no. 03
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Terminated
Facility Name
Sunpharma site no. 16
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pendleton B Wickersham, M.D.
Phone
210-477-2626
Email
drwickersham@cttexas.com
Facility Name
Sunpharma site no. 01
City
Tomball
State/Province
Texas
ZIP/Postal Code
77375
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shaikh Arif Ali, M.D.
Phone
281-517-0550
Email
drali@dmclinicalresearch.com
Facility Name
Sunpharma Site no. 121
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Sunpharma site no. 12
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Individual Site Status
Withdrawn
Facility Name
Sunpharma Site no. 81
City
Phillip
State/Province
Australian Capital Territory
ZIP/Postal Code
2606
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Annamma Dorai-Raj
Phone
61262828410
First Name & Middle Initial & Last Name & Degree
diana@wodedermatology.com.au
Facility Name
Sunpharma Site no. 84
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Individual Site Status
Withdrawn
Facility Name
Sunpharma Site no 68
City
Maroochydore
State/Province
Queensland
ZIP/Postal Code
4558
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Nash
Phone
61754431033
Email
drpnash@tpg.com.au
Facility Name
Sunpharma site no. 24
City
Hobart
State/Province
Tasmania
ZIP/Postal Code
7000
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jane Zochling, Mmed, FRACP
Phone
61-36223-8802
Email
jzochling@southernclinicalresearch.com.au
Facility Name
Sunpharma Site no 67
City
Camberwell
State/Province
Victoria
ZIP/Postal Code
3145
Country
Australia
Individual Site Status
Withdrawn
Facility Name
Sunpharma Site no. 82
City
Fitzroy
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Evange Romas
Phone
03 9231 3645
Email
fatima.sullivan@svha.org.au
Facility Name
Sunpharma Site no. 83
City
Murdoch
State/Province
Western Australia
ZIP/Postal Code
6150
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Helen Keen
Phone
61424180842
Email
daniel.lightowler@uwa.edu.au
Facility Name
Sunpharma Site no. 97
City
Ontario
ZIP/Postal Code
L3P 1X2
Country
Canada
Individual Site Status
Active, not recruiting
Facility Name
Sunpharma site 98
City
Quebec
ZIP/Postal Code
G8Z 1Y2
Country
Canada
Individual Site Status
Active, not recruiting
Facility Name
Sun pharma site 99
City
Brno
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Petr Nemec
Phone
+420 545 214 556 ext:
Email
revmatologie.nemec@seznam.cz
Facility Name
Sunpharma Site no. 100
City
Prague 2
Country
Czechia
Individual Site Status
Active, not recruiting
Facility Name
Sunpharma Site no. 101
City
Prague
ZIP/Postal Code
14000
Country
Czechia
Individual Site Status
Active, not recruiting
Facility Name
Sunpharma Site no. 96
City
Zlín
ZIP/Postal Code
760 01
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Petr Vitek
Phone
61861522222
Email
pv.medical@seznam.cz
Facility Name
Sunpharma Site no. 125
City
Sabadell
ZIP/Postal Code
8208
Country
Estonia
Individual Site Status
Active, not recruiting
Facility Name
Sunpharma Site no. 85
City
Tallinn
ZIP/Postal Code
10117
Country
Estonia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sandra Meisalu
Phone
3726109434
Email
sandra.talli@innomedica.ee
Facility Name
Sunpharma site no. 102
City
Tallin
ZIP/Postal Code
13419
Country
Estonia
Individual Site Status
Active, not recruiting
Facility Name
Sunpharma Site no. 87
City
Tartu
ZIP/Postal Code
50106
Country
Estonia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Airi Poder
Phone
3725058949
Email
airi.poder@std.ee
Facility Name
Sunpharma Site no. 86
City
Tartu
ZIP/Postal Code
50708
Country
Estonia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raili Müller
Phone
3725167731
Email
raili.myller@meditrials.ee
Facility Name
Sunpharma Site no. 89
City
Bad Doberan
ZIP/Postal Code
18209
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gunther Neeck
Phone
+49(0)38203 -73190
Email
gunther.neeck@biomedro.de
Facility Name
Sunpharma Site no. 91
City
Berlin
ZIP/Postal Code
12161
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jan Frederic Brandt-Juergens
Phone
4.91747E+11
Email
info@rheumapraxis-brandt-juergens.de
Facility Name
Sunpharma Site no. 90
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andreas Krause
Phone
+49 30 94792300
Email
andreas.krause@immanuelalbertinen.de
Facility Name
Sunpharma Site no. 103
City
Herne
ZIP/Postal Code
44649
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xenofon Baraliakos
Phone
+49 2325 592 ext: 131
Email
Xenofon.Baraliakos@elisabethgruppe.de
Facility Name
Sunpharma Site no. 120
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Sunpharma Site no. 104
City
Milan
ZIP/Postal Code
20089
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Sunpharma Site no. 126
City
Daejeon
ZIP/Postal Code
35015
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Sunpharma Site no 69
City
Incheon
ZIP/Postal Code
22332
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Won Park
Phone
82328903483
Email
parkwon@inha.ac.kr
Facility Name
Sunpharma Site no 72
City
Seoul
ZIP/Postal Code
16499
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chang-Hee Suh
Phone
82-31-219-5118
Email
hopeajou@aumc.ac.kr
Facility Name
Sunpharma Site no 71
City
Seoul
ZIP/Postal Code
3080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
EunBong Lee
Facility Name
Sunpharma Site no 70
City
Seoul
ZIP/Postal Code
4763
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chan-Bum Choi
Phone
82-2-2290-9208
Email
angeloeye@naver.com
Facility Name
Sunpharma Site no. 95
City
Warsaw
State/Province
Mazowiecki
ZIP/Postal Code
05-830
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marek Krogulec
Phone
48227298856
Email
marekkrogulec@wp.pl
Facility Name
Sunpharma Site no. 93
City
Bialystok
ZIP/Postal Code
15-879
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna N. Nowak
Phone
48669142505
Email
nowak@clinicmed.pl
Facility Name
Sunpharma Site no. 110
City
Białystok
ZIP/Postal Code
15-351
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arthur Racewicz
Facility Name
Sunpharma Site no. 94
City
Krakow
ZIP/Postal Code
30-033
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Grazyna Pulka
Phone
48124223271
Email
allmedpl@gmail.com
Facility Name
Sunpharma Site no. 109
City
Krakow
ZIP/Postal Code
30-510
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Sunpharma Site no. 107
City
Lublin
ZIP/Postal Code
20-607
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dariusz Chudzik
Phone
48517226631
Email
dariuszbchudzik@wp.pl
Facility Name
Sunpharma Site no. 106
City
Ponzan
ZIP/Postal Code
60-529
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zygmunt Adamski
Phone
+48 61 841 17 24 ext:
Email
prof.adamski@gmail.com
Facility Name
Sunpharma Site no. 92
City
Poznan
ZIP/Postal Code
61-113
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Rychlewska-Hanczewska
Phone
48603309321
Email
a.hanczewska@wp.pl
Facility Name
Sunpharma Site no. 108
City
Torun
ZIP/Postal Code
87-100
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Slawomir Jeka
Phone
+48 523 655 520 ext:
Email
s.jeka@wp.pl
Facility Name
Sunpharma Site no. 111
City
Warszawa
ZIP/Postal Code
02-118
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Rell-Bakalarska
Phone
+48 501 792 039 ext:
Email
rell-bakalarska@wp.pl
Facility Name
Sunpharma Site no. 88
City
Martin
ZIP/Postal Code
3601
Country
Slovakia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Viliam Manka
Phone
421 902283047
Email
vilcoo@gmail.com
Facility Name
Sunpharma Site no. 113
City
Rimavska Sobota
ZIP/Postal Code
97901
Country
Slovakia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Viola Husarova
Phone
421908920669
Email
husarov001@gmail.com
Facility Name
Sunpharma Site no. 114
City
Svidnik
ZIP/Postal Code
8901
Country
Slovakia
Individual Site Status
Active, not recruiting
Facility Name
Sunpharma Site no. 112
City
Vahom
ZIP/Postal Code
91501
Country
Slovakia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marianna Hauptvoglova
Phone
+421911406561 ext:
Email
hauptvoglova2@centrum.cz
Facility Name
Sunpharma Site no. 115
City
A Coruña
ZIP/Postal Code
15706
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Sunpharma Site no 57
City
Cordoba
ZIP/Postal Code
14004
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alejandro Escudero Contreras
Email
alejandro.escudero.sspa@juntadeandalucia.es
Facility Name
SunPharma Site No 23
City
Córdoba
ZIP/Postal Code
14004
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alejandro Escudero Contreras, Degree in Med.
Phone
34957010429
Email
alejandro.escudero.sspa@juntadeandalucia.es
Facility Name
Sunpharma Site no. 118
City
Gran Canaria
ZIP/Postal Code
35010
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Sunpharma Site no 58
City
La Coruña
ZIP/Postal Code
15006
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francisco Javier Blanco Garcia
Phone
981176398
Email
fblagar@sergas.es
Facility Name
Sunpharma Site no. 78
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alejandro Balsa
Phone
34917277193
Email
alejandro.balsa@salud.madrid.org
Facility Name
Sunpharma Site no. 116
City
Malaga
ZIP/Postal Code
29009
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonio Fernandez Nebro
Phone
34951029000
Email
afnebro@gmail.com
Facility Name
Sunpharma Site no. 77
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paula Cejas
Phone
34664472474
Email
pcejashil@gmail.com
Facility Name
Sunpharma Site no. 117
City
Sevilla
ZIP/Postal Code
41014
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raquel Hernandez Sanchez
Facility Name
Sunpharma Site no 59
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pilar Trenor Larraz
Phone
34961973787
Email
reumaensayosclinico@gmail.com
Facility Name
Sunpharma Site no 51
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Individual Site Status
Withdrawn
Facility Name
Sunpharma Site no 65
City
Taipei
State/Province
Pai-Tou
ZIP/Postal Code
112
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hsiao-Yi Lin
Phone
886-933-7-399
Email
doc1116d@gmail.com
Facility Name
Sunpharma Site no 63
City
Jianguo
State/Province
Taichung
ZIP/Postal Code
402
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James Cheng-Chung Wei
Phone
886 4-2473 9595
Email
wei3228@gmail.com
Facility Name
Sunpharma Site no. 79
City
Hsinchu
ZIP/Postal Code
300
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hsien-Yi Chiu
Phone
886-928-186-936
Email
extra.owl0430@yahoo.com.tw
Facility Name
Sunpharma Site no. 80
City
Kaohsiung
ZIP/Postal Code
80756
Country
Taiwan
Individual Site Status
Withdrawn
Facility Name
Sunpharma Site no 62
City
Kaohsiung
ZIP/Postal Code
833
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ji-Chen Ho
Phone
8.86976E+11
Email
jichenho@cgmh.org.tw
Facility Name
Sunpharma Site no 61
City
Taichung
ZIP/Postal Code
704
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joung-Liang Lan
Phone
886 937759007
Email
jll.trial@gmail.com
Facility Name
Sunpharma Site no 60
City
Tainan
ZIP/Postal Code
710
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hung-An Chen
Phone
88662812811
Email
hachen801039@yahoo.com.tw
Facility Name
Sunpharma Site no 64
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yun-Ting Chang
Phone
+886 4-24739595
Email
qwer741214@yahoo.com.tw
Facility Name
Sunpharma Site no 66
City
Taipei
ZIP/Postal Code
114
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hsiang-Cheng Chen
Phone
886287923311
Email
hccheng@mail.ndmctsgh.edu.tw

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Efficacy and Safety of Tildrakizumab Compared to Placebo in Subjects With Active Psoriatic Arthritis I (INSPIRE 1)

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