Back to resultsA Study to Evaluate Safety and Effectiveness of Cendakimab (CC-93538) in Participants With Moderate to Severe Atopic Dermatitis
Primary Purpose
Dermatitis, Atopic, Eczema
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
CC-93538
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Dermatitis, Atopic focused on measuring Atopic Dermatitis, Cendakimab, CC-93538
Eligibility Criteria
Inclusion Criteria:
Participants must satisfy the following criteria to be enrolled in the study:
- Participant must be ≥ 18 years and ≤ 75 years of age and have a body weight of ≥ 40 kg (88.2 lb) at the time of signing the informed consent form (ICF).
- Participant has chronic atopic dermatitis (AD) as defined by Hanifin and Rajka that has been present for ≥ 1 year prior to the baseline visit (Day 1).
Participant has moderate to severe, active, and symptomatic AD defined by meeting all of the following criteria on the day of the baseline visit (Day 1):
- Body Surface Area (BSA) ≥ 10%, and
- EASI score ≥ 16, and
- vIGA-AD ≥ 3, and
- Pruritus Numeric Rating Scale (NRS) severity score ≥ 4.
- Participant must have a documented history of inadequate response to treatment with topical medications for at least 4 weeks, unless topical treatments are otherwise medically inadvisable or has required systemic therapy for control of disease.
- Participant must be willing to apply a stable dose of topical emollient (eg, over-the-counter moisturizer, non-medicated emollient, etc.) twice daily for ≥ 7 days prior to the Baseline visit and continue application throughout the study.
- Participant must commit to avoid prolonged exposure to the sun and not to use tanning booths, sun lamps or other ultraviolet light sources during the study.
- Participants currently receiving concomitant medications for any reason other than AD, such as inhaled corticosteroids, leukotriene receptor antagonists (eg, montelukast), or mast cell stabilizers (eg, cromolyn sodium) for asthma, must be on a stable regimen, which is defined as not starting a new drug, changing, or stopping dosage within 7 days or 5 half-lives (whichever is longer) prior to Day 1 and through the treatment duration of the study.
- Female participants of childbearing potential must agree to practice a highly effective method of contraception.
Exclusion Criteria:
- The presence of any of the following will exclude a participant from enrollment: Evidence of an active and/or concurrent inflammatory skin condition (eg, seborrheic dermatitis, psoriasis, acute allergic contact dermatitis, etc.) that would interfere with the Investigator or participant-driven evaluations of AD.
- Evidence of acute AD flare between the Screening and Baseline/ Randomization (eg, doubling of the EASI score between Screening and Baseline).
- Use of topical treatments that could affect the assessment of AD (eg, corticosteroids, calcineurin inhibitors, tars, antibiotic creams, topical antihistamines) within 7 days of the Day 1 visit.
- Received phototherapy narrowband UVB (NB-UVB) or broad band phototherapy within 4 weeks prior to the Baseline visit.
- Evidence of immunosuppression, participant is receiving, or has received systemic immunosuppressive or immunomodulating drugs (eg, azathioprine, cyclosporine, systemic corticosteroids, interferon gamma (IFN-γ), Janus kinase inhibitors, methotrexate, mycophenolate-mofetil, etc.) within 4 weeks prior to the Baseline visit.
- Treatment with immunomodulatory biologics
- Concurrent treatment with another IP
- Received a live attenuated vaccine within 1 month prior to the first Screening Visit or anticipates the need to be vaccinated with a live attenuated vaccine during the study.
- Active parasitic/helminthic infection or a suspected parasitic/helminthic infection.
- Ongoing infection
- A history of idiopathic anaphylaxis or a major immunologic reaction (such as anaphylactic reaction, anaphylactoid reaction, or serum sickness) to an immunoglobulin G (IgG) containing agent. A known hypersensitivity to any ingredient in the investigational product (IP) is also exclusionary.
Sites / Locations
- Clinical Research Center of Alabama
- Local Institution - 119
- Cahaba Dermatology
- Local Institution - 114
- Burke Pharmaceutical Research
- Local Institution - 129
- First OC Dermatology
- Local Institution - 105
- George Washington University School of Medicine and Health Sciences
- Local Institution - 128
- Total Vein and Skin, LLC
- Local Institution - 106
- Palm Beach Dermatology Group
- GCP Global Clinical Professionals
- Local Institution - 135
- ForCare Clinical Research
- Local Institution - 101
- Local Institution - 103
- Metabolic Research Institute Inc
- Aeroallergy Research Labs of Savannah
- Local Institution - 134
- Local Institution - 108
- Sneeze Wheeze and Itch Associates LLC
- DS Research
- Local Institution - 115
- Dawes Fretzin Clinical Research Group, LLC
- Local Institution - 110
- Local Institution - 107
- Randall Dermatology
- Local Institution - 138
- Randall Dermatology - Westfield Campus
- Kansas City Dermatology P.A.
- Local Institution - 116
- DS Research
- Local Institution - 117
- DermAssociates
- Local Institution - 125
- Local Institution - 133
- Skin Research Clarkston/Clarkston Dermatology
- Local Institution - 137
- Skin Specialists PC
- JDR Dermatology Research, LLC
- Local Institution - 121
- Local Institution - 112
- Skin Laser and Surgery Specialists of New York and New Jersey LLC
- Icahn School of Medicine at Mount Sinai
- Local Institution - 130
- Local Institution - 126
- Sadick Research Group
- Central Sooner Research
- Local Institution - 111
- Local Institution - 127
- Vital Prospects Clinical Research Institute PC - CRN - PPDS
- Local Institution - 109
- Oregon Medical Research Center, P.C.
- Clinical Partners, LLC
- Local Institution - 123
- International Clinical Research
- Local Institution - 100
- Clinical Research Partners LLC
- Local Institution - 104
- West End Dermatology Associates
- Institute for Skin Advancement
- Local Institution - 203
- Local Institution - 213
- Rao Dermatology
- Dr. Chih-ho Hong Medical Inc.
- Local Institution - 207
- Enverus Medical Research
- Local Institution - 200
- Local Institution - 205
- Wiseman Dermatology Research Inc.
- Local Institution - 208
- Lynderm Research Inc
- DermEdge
- Local Institution - 211
- Local Institution - 209
- The Centre for Clinical Trials Inc.
- Centre de Recherche Dermatologique du Quebec Metropolitain CRDQ
- Local Institution - 202
- Kawashima Dermatology
- Local Institution - 503
- Local Institution - 507
- Miyata Dermatology Clinic
- Kozni ambulance Kutna Hora
- Local Institution - 407
- Dermamedica
- Local Institution - 403
- CCBR Ostrava
- Local Institution - 404
- Center for Clinical and Basic Research Czech Pardubice
- Local Institution - 405
- CCBR Czech Prague s.r.o.
- Local Institution - 400
- FN Motol
- Local Institution - 401
- Clintrial
- Local Institution - 402
- Dermatologicka Ambulance MUDr. Petr Trestik
- Local Institution - 406
- Fukuoka University Hospital
- Local Institution - 514
- Kyushu Central Hospital of the Mutual Aid Association of Public School Teachers
- Local Institution - 504
- Ichinomiya Municipal Hospital
- Local Institution - 506
- Local Institution - 511
- Teikyo University Hospital
- Local Institution - 515
- Saruwatari Dermatology Clinic
- Local Institution - 513
- Yamanashi Prefectual Central Hospital
- Local Institution - 505
- University Hospital Kyoto Prefectural University of Medicine
- Charme-Clinique
- Local Institution - 510
- Local Institution - 508
- Nagoya City University Hospital
- Local Institution - 512
- Takagi Dermatology
- Local Institution - 517
- Nakatsu Hifuka Clinic
- Local Institution - 500
- Sapporo Skin Clinic
- Local Institution - 501
- Medical Corporation Kojinkai Housui Sogo Medical Clinic
- Local Institution - 502
- Tokyo Medical University Hospital
- Local Institution - 509
- Nomura Dermatology Clinic
- Copernicus Podmiot Leczniczy Sp. z o.o.
- Local Institution - 310
- Care Clinic
- Local Institution - 309
- Centrum Medyczne Angelius Provita
- Local Institution - 306
- Centrum Medyczne Dermoklinika
- Local Institution - 311
- Local Institution - 312
- Miejski Szpital Zespolony w Olsztynie
- Klinika Zdybski
- Local Institution - 300
- Laser Clinic Dermatologia Laserowa Medycyna Estetyczna
- Local Institution - 308
- Local Institution - 302
- Twoja Przychodnia Szczecinskie Centrum Medyczne
- High-Med Przychodnia Specjalistyczna
- Local Institution - 301
- Klinika Ambroziak Estederm
- Local Institution - 307
- Wojskowy Instytut Medyczny
- Centrum Zdrowia WroMedica
- Local Institution - 305
- Kliniczny Szpital Wojewódzki nr 1 im. F. Chopina w Rzeszowie
- Local Institution - 304
- Local Institution - 303
- Specjalistyczne Gabinety Lekarskie DERMED
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
Dose 1: CC-93538 SC QW
Dose 2: CC-93538 and Placebo SC Q2W
Dose 3: CC-93538 and Placebo SC Q2W
Placebo SC QW
Arm Description
Administration of CC-93538 Subcutaneous (SC) Once weekly (QW) for 16 weeks.
Starting at the baseline visit, active IP will be administered. On the alternate weeks, placebo will be administered to maintain the blind.
Starting at the baseline visit, active IP and matching placebo will be administered. On the alternate weeks, placebo will be administered weekly to maintain the blind.
Administration of placebo each week.
Outcomes
Primary Outcome Measures
Percent change in EASI from Baseline at Week 16
The Eczema Area and Severity Index (EASI) is a composite scoring system assessed by the Investigator based on the proportion of each of the 4 body regions (head and neck, upper limbs, lower limbs, and trunk) affected with Atopic Dermatitis (AD)
Secondary Outcome Measures
Proportion of participants with an vIGAAD score from Baseline at Week 16
The Validated Investigator Global Assessment (vIGA)-AD is a validated 5-point assessment intended to assess the global severities of key acute clinical signs of AD, including erythema, induration/papulation, oozing/crusting (lichenification excluded).
Proportion of participants with at least a 75% improvement from Baseline in Eczema Area and Severity Index (EASI-75) at Week 16
The EASI is a composite scoring system assessed by the Investigator based on the proportion of each of the 4 body regions (head and neck, upper limbs, lower limbs, and trunk) affected with AD.
Percent change from Baseline in Pruritus Numerical Rating Scale (NRS) at Week 16
Pruritus NRS is a single item, participant reported outcome (PRO) of itch severity.
Proportion of participants with Pruritus NRS change of ≥ 4 points from Baseline at Week 16
Pruritus NRS is a single item, participant reported outcome (PRO) of itch severity.
Time to achieve at least 4 points of improvement in the severity of pruritus NRS scale in the first 16 weeks of treatment
Pruritus NRS is a single item, participant reported outcome (PRO) of itch severity.
Proportion of participants with at least a 90% improvement from Baseline in Eczema Area and Severity Index (EASI-90) at Week 16
The Eczema Area and Severity Index (EASI) is a composite scoring system assessed by the Investigator based on the proportion of each of the 4 body regions (head and neck, upper limbs, lower limbs, and trunk) affected with Atopic Dermatitis (AD)
Mean change in SCORAD Scores from Baseline at Week 16
The Scoring Atopic Dermatitis Index (SCORAD) is a validated scoring index for atopic dermatitis, which combines extent (0 to 100), severity (0 to 18), and subjective symptoms (0 to 20) based on pruritus and sleep loss, each scored (0 to 10).
Percent change in BSA involved with AD from baseline at Week 16
Percentage body surface area of the skin that displays signs or symptoms consistent with atopic dermatitis
Incidence of Adverse Events (AEs)
An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE.
Assessment of Immunogenicity through measurement of serum concentrations of anti-drug antibodies to CC-93538
Evaluated by the presence of anti-drug antibodies to CC-93538
Pharmacokinetics-Cthrough
Serum trough concentration of CC-93538
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04800315
Brief Title
A Study to Evaluate Safety and Effectiveness of Cendakimab (CC-93538) in Participants With Moderate to Severe Atopic Dermatitis
Official Title
A Phase 2, Multicenter, Global, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Safety and Efficacy of Cendakimab (CC-93538) in Adult Subjects With Moderate to Severe Atopic Dermatitis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
May 14, 2021 (Actual)
Primary Completion Date
July 20, 2022 (Actual)
Study Completion Date
November 9, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celgene
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
The purpose of this study is to evaluate the effectiveness and safety of 3 dose regimen of CC-93538 in adult participants with moderate to severe Atopic Dermatitis (AD).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dermatitis, Atopic, Eczema
Keywords
Atopic Dermatitis, Cendakimab, CC-93538
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
221 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dose 1: CC-93538 SC QW
Arm Type
Experimental
Arm Description
Administration of CC-93538 Subcutaneous (SC) Once weekly (QW) for 16 weeks.
Arm Title
Dose 2: CC-93538 and Placebo SC Q2W
Arm Type
Experimental
Arm Description
Starting at the baseline visit, active IP will be administered. On the alternate weeks, placebo will be administered to maintain the blind.
Arm Title
Dose 3: CC-93538 and Placebo SC Q2W
Arm Type
Experimental
Arm Description
Starting at the baseline visit, active IP and matching placebo will be administered.
On the alternate weeks, placebo will be administered weekly to maintain the blind.
Arm Title
Placebo SC QW
Arm Type
Placebo Comparator
Arm Description
Administration of placebo each week.
Intervention Type
Drug
Intervention Name(s)
CC-93538
Other Intervention Name(s)
RPC4064, cendakimab
Intervention Description
Subcutaneous once weekly
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Subcutaneous Every other week
Primary Outcome Measure Information:
Title
Percent change in EASI from Baseline at Week 16
Description
The Eczema Area and Severity Index (EASI) is a composite scoring system assessed by the Investigator based on the proportion of each of the 4 body regions (head and neck, upper limbs, lower limbs, and trunk) affected with Atopic Dermatitis (AD)
Time Frame
Up to week 16
Secondary Outcome Measure Information:
Title
Proportion of participants with an vIGAAD score from Baseline at Week 16
Description
The Validated Investigator Global Assessment (vIGA)-AD is a validated 5-point assessment intended to assess the global severities of key acute clinical signs of AD, including erythema, induration/papulation, oozing/crusting (lichenification excluded).
Time Frame
Up to week 16
Title
Proportion of participants with at least a 75% improvement from Baseline in Eczema Area and Severity Index (EASI-75) at Week 16
Description
The EASI is a composite scoring system assessed by the Investigator based on the proportion of each of the 4 body regions (head and neck, upper limbs, lower limbs, and trunk) affected with AD.
Time Frame
Up to week 16
Title
Percent change from Baseline in Pruritus Numerical Rating Scale (NRS) at Week 16
Description
Pruritus NRS is a single item, participant reported outcome (PRO) of itch severity.
Time Frame
Up to week 16
Title
Proportion of participants with Pruritus NRS change of ≥ 4 points from Baseline at Week 16
Description
Pruritus NRS is a single item, participant reported outcome (PRO) of itch severity.
Time Frame
Up to week 16
Title
Time to achieve at least 4 points of improvement in the severity of pruritus NRS scale in the first 16 weeks of treatment
Description
Pruritus NRS is a single item, participant reported outcome (PRO) of itch severity.
Time Frame
Up to week 16
Title
Proportion of participants with at least a 90% improvement from Baseline in Eczema Area and Severity Index (EASI-90) at Week 16
Description
The Eczema Area and Severity Index (EASI) is a composite scoring system assessed by the Investigator based on the proportion of each of the 4 body regions (head and neck, upper limbs, lower limbs, and trunk) affected with Atopic Dermatitis (AD)
Time Frame
Up to week 16
Title
Mean change in SCORAD Scores from Baseline at Week 16
Description
The Scoring Atopic Dermatitis Index (SCORAD) is a validated scoring index for atopic dermatitis, which combines extent (0 to 100), severity (0 to 18), and subjective symptoms (0 to 20) based on pruritus and sleep loss, each scored (0 to 10).
Time Frame
Up to week 16
Title
Percent change in BSA involved with AD from baseline at Week 16
Description
Percentage body surface area of the skin that displays signs or symptoms consistent with atopic dermatitis
Time Frame
Up to week 16
Title
Incidence of Adverse Events (AEs)
Description
An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE.
Time Frame
Up to week 32
Title
Assessment of Immunogenicity through measurement of serum concentrations of anti-drug antibodies to CC-93538
Description
Evaluated by the presence of anti-drug antibodies to CC-93538
Time Frame
Up to week 32
Title
Pharmacokinetics-Cthrough
Description
Serum trough concentration of CC-93538
Time Frame
Up to week 32
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participants must satisfy the following criteria to be enrolled in the study:
Participant must be ≥ 18 years and ≤ 75 years of age and have a body weight of ≥ 40 kg (88.2 lb) at the time of signing the informed consent form (ICF).
Participant has chronic atopic dermatitis (AD) as defined by Hanifin and Rajka that has been present for ≥ 1 year prior to the baseline visit (Day 1).
Participant has moderate to severe, active, and symptomatic AD defined by meeting all of the following criteria on the day of the baseline visit (Day 1):
Body Surface Area (BSA) ≥ 10%, and
EASI score ≥ 16, and
vIGA-AD ≥ 3, and
Pruritus Numeric Rating Scale (NRS) severity score ≥ 4.
Participant must have a documented history of inadequate response to treatment with topical medications for at least 4 weeks, unless topical treatments are otherwise medically inadvisable or has required systemic therapy for control of disease.
Participant must be willing to apply a stable dose of topical emollient (eg, over-the-counter moisturizer, non-medicated emollient, etc.) twice daily for ≥ 7 days prior to the Baseline visit and continue application throughout the study.
Participant must commit to avoid prolonged exposure to the sun and not to use tanning booths, sun lamps or other ultraviolet light sources during the study.
Participants currently receiving concomitant medications for any reason other than AD, such as inhaled corticosteroids, leukotriene receptor antagonists (eg, montelukast), or mast cell stabilizers (eg, cromolyn sodium) for asthma, must be on a stable regimen, which is defined as not starting a new drug, changing, or stopping dosage within 7 days or 5 half-lives (whichever is longer) prior to Day 1 and through the treatment duration of the study.
Female participants of childbearing potential must agree to practice a highly effective method of contraception.
Exclusion Criteria:
The presence of any of the following will exclude a participant from enrollment: Evidence of an active and/or concurrent inflammatory skin condition (eg, seborrheic dermatitis, psoriasis, acute allergic contact dermatitis, etc.) that would interfere with the Investigator or participant-driven evaluations of AD.
Evidence of acute AD flare between the Screening and Baseline/ Randomization (eg, doubling of the EASI score between Screening and Baseline).
Use of topical treatments that could affect the assessment of AD (eg, corticosteroids, calcineurin inhibitors, tars, antibiotic creams, topical antihistamines) within 7 days of the Day 1 visit.
Received phototherapy narrowband UVB (NB-UVB) or broad band phototherapy within 4 weeks prior to the Baseline visit.
Evidence of immunosuppression, participant is receiving, or has received systemic immunosuppressive or immunomodulating drugs (eg, azathioprine, cyclosporine, systemic corticosteroids, interferon gamma (IFN-γ), Janus kinase inhibitors, methotrexate, mycophenolate-mofetil, etc.) within 4 weeks prior to the Baseline visit.
Treatment with immunomodulatory biologics
Concurrent treatment with another IP
Received a live attenuated vaccine within 1 month prior to the first Screening Visit or anticipates the need to be vaccinated with a live attenuated vaccine during the study.
Active parasitic/helminthic infection or a suspected parasitic/helminthic infection.
Ongoing infection
A history of idiopathic anaphylaxis or a major immunologic reaction (such as anaphylactic reaction, anaphylactoid reaction, or serum sickness) to an immunoglobulin G (IgG) containing agent. A known hypersensitivity to any ingredient in the investigational product (IP) is also exclusionary.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Clinical Research Center of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Local Institution - 119
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Cahaba Dermatology
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35244
Country
United States
Facility Name
Local Institution - 114
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35244
Country
United States
Facility Name
Burke Pharmaceutical Research
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913-6440
Country
United States
Facility Name
Local Institution - 129
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913-6440
Country
United States
Facility Name
First OC Dermatology
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Local Institution - 105
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
George Washington University School of Medicine and Health Sciences
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037-3201
Country
United States
Facility Name
Local Institution - 128
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037-3201
Country
United States
Facility Name
Total Vein and Skin, LLC
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33437
Country
United States
Facility Name
Local Institution - 106
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33484-6500
Country
United States
Facility Name
Palm Beach Dermatology Group
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33484-6500
Country
United States
Facility Name
GCP Global Clinical Professionals
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33702
Country
United States
Facility Name
Local Institution - 135
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33702
Country
United States
Facility Name
ForCare Clinical Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33624-2038
Country
United States
Facility Name
Local Institution - 101
City
Tampa
State/Province
Florida
ZIP/Postal Code
33624-2038
Country
United States
Facility Name
Local Institution - 103
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401-3430
Country
United States
Facility Name
Metabolic Research Institute Inc
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401-3430
Country
United States
Facility Name
Aeroallergy Research Labs of Savannah
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406-2668
Country
United States
Facility Name
Local Institution - 134
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406-2668
Country
United States
Facility Name
Local Institution - 108
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702-5115
Country
United States
Facility Name
Sneeze Wheeze and Itch Associates LLC
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702-5115
Country
United States
Facility Name
DS Research
City
Clarksville
State/Province
Indiana
ZIP/Postal Code
47129-2201
Country
United States
Facility Name
Local Institution - 115
City
Clarksville
State/Province
Indiana
ZIP/Postal Code
47129-2201
Country
United States
Facility Name
Dawes Fretzin Clinical Research Group, LLC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46256
Country
United States
Facility Name
Local Institution - 110
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46256
Country
United States
Facility Name
Local Institution - 107
City
West Lafayette
State/Province
Indiana
ZIP/Postal Code
47906-1569
Country
United States
Facility Name
Randall Dermatology
City
West Lafayette
State/Province
Indiana
ZIP/Postal Code
47906-1569
Country
United States
Facility Name
Local Institution - 138
City
Westfield
State/Province
Indiana
ZIP/Postal Code
46074
Country
United States
Facility Name
Randall Dermatology - Westfield Campus
City
Westfield
State/Province
Indiana
ZIP/Postal Code
46074
Country
United States
Facility Name
Kansas City Dermatology P.A.
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66215-2377
Country
United States
Facility Name
Local Institution - 116
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66215-2377
Country
United States
Facility Name
DS Research
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40241
Country
United States
Facility Name
Local Institution - 117
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40241
Country
United States
Facility Name
DermAssociates
City
Silver Spring
State/Province
Maryland
ZIP/Postal Code
20902-5006
Country
United States
Facility Name
Local Institution - 125
City
Silver Spring
State/Province
Maryland
ZIP/Postal Code
20902-5006
Country
United States
Facility Name
Local Institution - 133
City
Clarkston
State/Province
Michigan
ZIP/Postal Code
48346
Country
United States
Facility Name
Skin Research Clarkston/Clarkston Dermatology
City
Clarkston
State/Province
Michigan
ZIP/Postal Code
48346
Country
United States
Facility Name
Local Institution - 137
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68144
Country
United States
Facility Name
Skin Specialists PC
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68144
Country
United States
Facility Name
JDR Dermatology Research, LLC
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148
Country
United States
Facility Name
Local Institution - 121
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148
Country
United States
Facility Name
Local Institution - 112
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601-1974
Country
United States
Facility Name
Skin Laser and Surgery Specialists of New York and New Jersey LLC
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601-1974
Country
United States
Facility Name
Icahn School of Medicine at Mount Sinai
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021-5506
Country
United States
Facility Name
Local Institution - 130
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021-5506
Country
United States
Facility Name
Local Institution - 126
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States
Facility Name
Sadick Research Group
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States
Facility Name
Central Sooner Research
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73069-6301
Country
United States
Facility Name
Local Institution - 111
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73069-6301
Country
United States
Facility Name
Local Institution - 127
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136-8303
Country
United States
Facility Name
Vital Prospects Clinical Research Institute PC - CRN - PPDS
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136-8303
Country
United States
Facility Name
Local Institution - 109
City
Portland
State/Province
Oregon
ZIP/Postal Code
97223
Country
United States
Facility Name
Oregon Medical Research Center, P.C.
City
Portland
State/Province
Oregon
ZIP/Postal Code
97223
Country
United States
Facility Name
Clinical Partners, LLC
City
Johnston
State/Province
Rhode Island
ZIP/Postal Code
02919
Country
United States
Facility Name
Local Institution - 123
City
Johnston
State/Province
Rhode Island
ZIP/Postal Code
02919
Country
United States
Facility Name
International Clinical Research
City
Murfreesboro
State/Province
Tennessee
ZIP/Postal Code
37130
Country
United States
Facility Name
Local Institution - 100
City
Murfreesboro
State/Province
Tennessee
ZIP/Postal Code
37130
Country
United States
Facility Name
Clinical Research Partners LLC
City
Henrico
State/Province
Virginia
ZIP/Postal Code
23233-1487
Country
United States
Facility Name
Local Institution - 104
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23233-1436
Country
United States
Facility Name
West End Dermatology Associates
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23233-1436
Country
United States
Facility Name
Institute for Skin Advancement
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3A 2N1
Country
Canada
Facility Name
Local Institution - 203
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3A 2N1
Country
Canada
Facility Name
Local Institution - 213
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1C3
Country
Canada
Facility Name
Rao Dermatology
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1C3
Country
Canada
Facility Name
Dr. Chih-ho Hong Medical Inc.
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3R 6A7
Country
Canada
Facility Name
Local Institution - 207
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3R 6A7
Country
Canada
Facility Name
Enverus Medical Research
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3V 0C6
Country
Canada
Facility Name
Local Institution - 200
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3V 0C6
Country
Canada
Facility Name
Local Institution - 205
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3M 3Z4
Country
Canada
Facility Name
Wiseman Dermatology Research Inc.
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3M 3Z4
Country
Canada
Facility Name
Local Institution - 208
City
Markham
State/Province
Ontario
ZIP/Postal Code
L3P IX3
Country
Canada
Facility Name
Lynderm Research Inc
City
Markham
State/Province
Ontario
ZIP/Postal Code
L3P IX3
Country
Canada
Facility Name
DermEdge
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L4Y 4C5
Country
Canada
Facility Name
Local Institution - 211
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L4Y 4C5
Country
Canada
Facility Name
Local Institution - 209
City
Oakville
State/Province
Ontario
ZIP/Postal Code
L6J 7W5
Country
Canada
Facility Name
The Centre for Clinical Trials Inc.
City
Oakville
State/Province
Ontario
ZIP/Postal Code
L6J 7W5
Country
Canada
Facility Name
Centre de Recherche Dermatologique du Quebec Metropolitain CRDQ
City
Quebec
ZIP/Postal Code
G1V 4X7
Country
Canada
Facility Name
Local Institution - 202
City
Quebec
ZIP/Postal Code
G1V 4X7
Country
Canada
Facility Name
Kawashima Dermatology
City
Ichikawa
ZIP/Postal Code
272-0033
Country
China
Facility Name
Local Institution - 503
City
Ichikawa
ZIP/Postal Code
272-0033
Country
China
Facility Name
Local Institution - 507
City
Matsudo
ZIP/Postal Code
271-0092
Country
China
Facility Name
Miyata Dermatology Clinic
City
Matsudo
ZIP/Postal Code
271-0092
Country
China
Facility Name
Kozni ambulance Kutna Hora
City
Kutná Hora
ZIP/Postal Code
284 01
Country
Czechia
Facility Name
Local Institution - 407
City
Kutná Hora
ZIP/Postal Code
284 01
Country
Czechia
Facility Name
Dermamedica
City
Náchod
ZIP/Postal Code
547 01
Country
Czechia
Facility Name
Local Institution - 403
City
Náchod
ZIP/Postal Code
547 01
Country
Czechia
Facility Name
CCBR Ostrava
City
Ostrava
ZIP/Postal Code
702 00
Country
Czechia
Facility Name
Local Institution - 404
City
Ostrava
ZIP/Postal Code
702 00
Country
Czechia
Facility Name
Center for Clinical and Basic Research Czech Pardubice
City
Pardubice
ZIP/Postal Code
530 02
Country
Czechia
Facility Name
Local Institution - 405
City
Pardubice
ZIP/Postal Code
530 02
Country
Czechia
Facility Name
CCBR Czech Prague s.r.o.
City
Prague
ZIP/Postal Code
130 00
Country
Czechia
Facility Name
Local Institution - 400
City
Prague
ZIP/Postal Code
130 00
Country
Czechia
Facility Name
FN Motol
City
Praha 5
ZIP/Postal Code
15006
Country
Czechia
Facility Name
Local Institution - 401
City
Praha 5
ZIP/Postal Code
15006
Country
Czechia
Facility Name
Clintrial
City
Praha
ZIP/Postal Code
100 00
Country
Czechia
Facility Name
Local Institution - 402
City
Praha
ZIP/Postal Code
100 00
Country
Czechia
Facility Name
Dermatologicka Ambulance MUDr. Petr Trestik
City
Svitavy
ZIP/Postal Code
568 02
Country
Czechia
Facility Name
Local Institution - 406
City
Svitavy
ZIP/Postal Code
568 02
Country
Czechia
Facility Name
Fukuoka University Hospital
City
Fukuoka-shi, Fukuoka
ZIP/Postal Code
814-0180
Country
Japan
Facility Name
Local Institution - 514
City
Fukuoka-shi, Fukuoka
ZIP/Postal Code
814-0180
Country
Japan
Facility Name
Kyushu Central Hospital of the Mutual Aid Association of Public School Teachers
City
Fukuoka
ZIP/Postal Code
815-8588
Country
Japan
Facility Name
Local Institution - 504
City
Fukuoka
ZIP/Postal Code
815-8588
Country
Japan
Facility Name
Ichinomiya Municipal Hospital
City
Ichinomiya
ZIP/Postal Code
491-8558
Country
Japan
Facility Name
Local Institution - 506
City
Ichinomiya
ZIP/Postal Code
491-8558
Country
Japan
Facility Name
Local Institution - 511
City
Itabashi-ku
ZIP/Postal Code
173-8606
Country
Japan
Facility Name
Teikyo University Hospital
City
Itabashi-ku
ZIP/Postal Code
173-8606
Country
Japan
Facility Name
Local Institution - 515
City
Kagoshima
ZIP/Postal Code
890-0055
Country
Japan
Facility Name
Saruwatari Dermatology Clinic
City
Kagoshima
ZIP/Postal Code
890-0055
Country
Japan
Facility Name
Local Institution - 513
City
Kofu
ZIP/Postal Code
400-0027
Country
Japan
Facility Name
Yamanashi Prefectual Central Hospital
City
Kofu
ZIP/Postal Code
400-0027
Country
Japan
Facility Name
Local Institution - 505
City
Kyoto-City
ZIP/Postal Code
602-8566
Country
Japan
Facility Name
University Hospital Kyoto Prefectural University of Medicine
City
Kyoto-City
ZIP/Postal Code
602-8566
Country
Japan
Facility Name
Charme-Clinique
City
Matsudo
ZIP/Postal Code
270-2223
Country
Japan
Facility Name
Local Institution - 510
City
Matsudo
ZIP/Postal Code
270-2223
Country
Japan
Facility Name
Local Institution - 508
City
Nagoya
ZIP/Postal Code
467-8602
Country
Japan
Facility Name
Nagoya City University Hospital
City
Nagoya
ZIP/Postal Code
467-8602
Country
Japan
Facility Name
Local Institution - 512
City
Obihiro
ZIP/Postal Code
080-0013
Country
Japan
Facility Name
Takagi Dermatology
City
Obihiro
ZIP/Postal Code
080-0013
Country
Japan
Facility Name
Local Institution - 517
City
Osaka
ZIP/Postal Code
Osaka
Country
Japan
Facility Name
Nakatsu Hifuka Clinic
City
Osaka
ZIP/Postal Code
Osaka
Country
Japan
Facility Name
Local Institution - 500
City
Sapporo-shi, Hokkaido
ZIP/Postal Code
060-0063
Country
Japan
Facility Name
Sapporo Skin Clinic
City
Sapporo-shi, Hokkaido
ZIP/Postal Code
060-0063
Country
Japan
Facility Name
Local Institution - 501
City
Sapporo
ZIP/Postal Code
060-0063
Country
Japan
Facility Name
Medical Corporation Kojinkai Housui Sogo Medical Clinic
City
Sapporo
ZIP/Postal Code
060-0063
Country
Japan
Facility Name
Local Institution - 502
City
Shinjuku
ZIP/Postal Code
160-0023
Country
Japan
Facility Name
Tokyo Medical University Hospital
City
Shinjuku
ZIP/Postal Code
160-0023
Country
Japan
Facility Name
Local Institution - 509
City
Yokohoma City, Kanagawa
ZIP/Postal Code
221-0825
Country
Japan
Facility Name
Nomura Dermatology Clinic
City
Yokohoma City, Kanagawa
ZIP/Postal Code
221-0825
Country
Japan
Facility Name
Copernicus Podmiot Leczniczy Sp. z o.o.
City
Gdansk
ZIP/Postal Code
80-803
Country
Poland
Facility Name
Local Institution - 310
City
Gdansk
ZIP/Postal Code
80-803
Country
Poland
Facility Name
Care Clinic
City
Katowice
ZIP/Postal Code
40-568
Country
Poland
Facility Name
Local Institution - 309
City
Katowice
ZIP/Postal Code
40-568
Country
Poland
Facility Name
Centrum Medyczne Angelius Provita
City
Katowice
ZIP/Postal Code
40-611
Country
Poland
Facility Name
Local Institution - 306
City
Katowice
ZIP/Postal Code
40-611
Country
Poland
Facility Name
Centrum Medyczne Dermoklinika
City
Lodz
ZIP/Postal Code
90-436
Country
Poland
Facility Name
Local Institution - 311
City
Lodz
ZIP/Postal Code
90-436
Country
Poland
Facility Name
Local Institution - 312
City
Olsztyn
ZIP/Postal Code
10-229
Country
Poland
Facility Name
Miejski Szpital Zespolony w Olsztynie
City
Olsztyn
ZIP/Postal Code
10-229
Country
Poland
Facility Name
Klinika Zdybski
City
Ostrowiec Świętokrzyski
ZIP/Postal Code
27-400
Country
Poland
Facility Name
Local Institution - 300
City
Ostrowiec Świętokrzyski
ZIP/Postal Code
27-400
Country
Poland
Facility Name
Laser Clinic Dermatologia Laserowa Medycyna Estetyczna
City
Szczecin
ZIP/Postal Code
70-332
Country
Poland
Facility Name
Local Institution - 308
City
Szczecin
ZIP/Postal Code
70-332
Country
Poland
Facility Name
Local Institution - 302
City
Szczecin
ZIP/Postal Code
71-434
Country
Poland
Facility Name
Twoja Przychodnia Szczecinskie Centrum Medyczne
City
Szczecin
ZIP/Postal Code
71-434
Country
Poland
Facility Name
High-Med Przychodnia Specjalistyczna
City
Warsaw
ZIP/Postal Code
01-817
Country
Poland
Facility Name
Local Institution - 301
City
Warsaw
ZIP/Postal Code
01-817
Country
Poland
Facility Name
Klinika Ambroziak Estederm
City
Warsaw
ZIP/Postal Code
02-953
Country
Poland
Facility Name
Local Institution - 307
City
Warsaw
ZIP/Postal Code
02-953
Country
Poland
Facility Name
Wojskowy Instytut Medyczny
City
Warsaw
ZIP/Postal Code
04-141
Country
Poland
Facility Name
Centrum Zdrowia WroMedica
City
Wroclaw
ZIP/Postal Code
51-685
Country
Poland
Facility Name
Local Institution - 305
City
Wroclaw
ZIP/Postal Code
51-685
Country
Poland
Facility Name
Kliniczny Szpital Wojewódzki nr 1 im. F. Chopina w Rzeszowie
City
Wrocław
ZIP/Postal Code
50-367
Country
Poland
Facility Name
Local Institution - 304
City
Wrocław
ZIP/Postal Code
50-367
Country
Poland
Facility Name
Local Institution - 303
City
Łódź
ZIP/Postal Code
90-265
Country
Poland
Facility Name
Specjalistyczne Gabinety Lekarskie DERMED
City
Łódź
ZIP/Postal Code
90-265
Country
Poland
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Information relating to our policy on data sharing and the process for requesting data can be found at the following link:
https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/
IPD Sharing Time Frame
See Plan Description
IPD Sharing Access Criteria
See Plan Description
IPD Sharing URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html
Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/s/US/English/USenHome
Description
BMS Clinical Trial Patient Recruiting
URL
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls
Learn more about this trial
A Study to Evaluate Safety and Effectiveness of Cendakimab (CC-93538) in Participants With Moderate to Severe Atopic Dermatitis
We'll reach out to this number within 24 hrs