Back to resultsA Study to Assess Change in Disease Activity and Adverse Events of Oral Upadacitinib in Adult and Adolescent Participants With Moderate to Severe Hidradenitis Suppurativa Who Have Failed Anti-TNF Therapy (Step-Up HS)
Primary Purpose
Hidradenitis Suppurativa
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Upadacitinib
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hidradenitis Suppurativa focused on measuring Hidradenitis Suppurativa, Upadacitinib, ABT-494, Rinvoq, STEP-UP HS
Eligibility Criteria
Inclusion Criteria: Diagnosis of HS for at least 6 months prior to Baseline, as determined by the investigator (i.e., through medical history and interview of subject). Documented history of previous use of ≥ 1 TNF inhibitor for HS for at least 12 weeks and/or 1 approved non-anti-TNF biologic therapy for HS for at least 16 weeks characterized by inadequate response or for any duration characterized by intolerance as determined by the investigator. Participant must have a total AN count of ≥ 5 at Baseline. HS lesions must be present in at least 2 distinct anatomic areas at Baseline. At least 1 anatomic area of HS involvement characterized as Hurley Stage II or higher at Baseline. Draining fistula count of ≤ 20 at Baseline. Exclusion Criteria: History of active skin disease other than HS that could interfere with the assessment of HS, including skin infections (bacterial, fungal, or viral) requiring systemic treatment within 4 weeks of the Baseline visit. Treatment with any investigational drug of chemical or biologic nature within a minimum of 30 days or 5 half-lives (whichever is longer) prior to the first dose of study drug or be currently enrolled in another interventional clinical study. Investigational drugs are also prohibited during the study. Previous treatment with any cell-depleting therapies including but not limited to anti-CD20 (e.g., rituximab) within 12 months prior to Baseline or until B cell count returns to normal level or pre-treatment level. Use of prescription topical therapies (including topical antibiotics) that can also be used to treat HS within 14 days prior to the Baseline visit. Received any systemic (including oral) antibiotic treatment for HS or any other chronic inflammatory disorder within 14 days prior to the Baseline visit.
Sites / Locations
- Cahaba Dermatology Skin Health Center /ID# 254876Recruiting
- Medical Dermatology Specialist /ID# 254226Recruiting
- Clinical Trials Institute at Northwest Arkansas /ID# 254924Recruiting
- Burke Pharmaceutical Research /ID# 254238Recruiting
- Arkansas Research Trials, LLC /ID# 254233Recruiting
- NW Arkansas Clinical Trials Center /ID# 254311Recruiting
- T. Joseph Raoof, MD, Inc. /ID# 254374Recruiting
- Dermatology Research Associates /ID# 254846Recruiting
- Integrative Skin Science and Research /ID# 254930Recruiting
- Clinical Trials Research Institute /ID# 254466Recruiting
- Skin Care Research - Boca Raton /ID# 253814Recruiting
- Apex Clinical Trials /ID# 255756Recruiting
- Florida Academic Centers Research and Education /ID# 254011Recruiting
- Skin Care Research - Hollywood /ID# 254508Recruiting
- Advanced Clinical Research Institute /ID# 253746Recruiting
- Skin Care Research - Tampa /ID# 256440Recruiting
- Avita Clinical Research /ID# 254471Recruiting
- Centricity Research /ID# 255470Recruiting
- Treasure Valley Medical Research /ID# 255208Recruiting
- DeNova Research /ID# 254372Recruiting
- Northshore University Health System Dermatology Clinical Trials Unit /ID# 254389Recruiting
- Dawes Fretzin, LLC /ID# 254390Recruiting
- Michigan Dermatology Institute /ID# 254468Recruiting
- MediSearch Clinical Trials /ID# 254392Recruiting
- Vivida Dermatology- Flamingo /ID# 254227Recruiting
- Skin Cancer and Dermatology Institute (SCDI) /ID# 254410Recruiting
- Onsite Clinical Solutions /ID# 254854Recruiting
- ClinOhio Research Services /ID# 254851Recruiting
- Dermatologists of Southwest Ohio, Inc /ID# 254297Recruiting
- Lynn Health Science Institute (LHSI) /ID# 253791Recruiting
- Arlington Research Center, Inc /ID# 253805Recruiting
- Bellaire Dermatology Associates /ID# 253797Recruiting
- Dermatology Treatment and Research Center /ID# 253795Recruiting
- Modern Research Associates, PLLC /ID# 253810Recruiting
- HRMD Research Dallas /ID# 255256Recruiting
- Suzanne Bruce and Associates-Houston /ID# 254228Recruiting
- Texas Dermatology Research Center, LLC /ID# 254928Recruiting
- Center for Clinical Studies - Webster TX /ID# 254242Recruiting
- The Education & Research Foundation, Inc. /ID# 254852Recruiting
- Virginia Clinical Research, Inc. /ID# 254538Recruiting
- Premier Clinical Research /ID# 254847Recruiting
- Fukuoka University Hospital /ID# 254729Recruiting
- Meiwa Hospital /ID# 254728Recruiting
- University Hospital Kyoto Prefectural University of Medicine /ID# 254481Recruiting
- University of the Ryukyus Hospital /ID# 254517Recruiting
- Kindai University Hospital /ID# 254574Recruiting
- Toranomon Hospital /ID# 253819Recruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm Type
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Period 1: Upadacitinib Dose A
Period 1: Placebo
Period 2: Group 1 - Upadacitinib Dose A
Period 2: Group 2 - Placebo
Period 2: Group 3 - Upadacitinib Dose A
Period 2: Group 4 - Upadacitinib Dose A
Period 2: Group 5 - Upadacitinib Dose B
Period 2: Group 6 - Placebo
Period 3: Long-Term Extension
Arm Description
Participants will receive Upadicitinib Dose A once daily for 16 weeks.
Participants will receive Placebo once daily for 16 weeks.
Participants who were randomized to placebo in Period 1 who did not achieve HiSCR 50 (clinical non-responder, CNR) at Week 16 will receive Upadacitinib Dose A once daily for 20 weeks.
Participants who were randomized to placebo in Period 1 who achieve HiSCR 50 (clinical responder, CR) at Week 16 will continue to receive placebo once daily for 20 weeks.
Participants who were randomized to upadacitinib Dose A in Period 1 who did not achieve HiSCR 50 (CNR) at Week 16 will continue to receive upadacitinib Dose A once daily for 20 weeks.
Participants who were randomized to upadacitinib Dose A in Period 1 who achieve HiSCR 50 (CR) at Week 16 will receive upadacitinib Dose A once daily for 20 weeks.
Participants who were randomized to upadacitinib Dose A in Period 1 who achieve HiSCR 50 (CR) at Week 16 will receive upadacitinib Dose B once daily for 20 weeks.
Participants who were randomized to upadacitinib Dose A in Period 1 who achieve HiSCR 50 (CR) at Week 16 will receive placebo once daily for 20 weeks.
Eligible participants will continue to receive upadacitinib or placebo for 68 weeks. Participants will be followed-up for approximately 30 days.
Outcomes
Primary Outcome Measures
Percentage of Participants Achieving Hidradenitis Suppurative Clinical Response (HiSCR) 50
HiSCR 50 is defined as at least a 50% reduction in the total abscess and inflammatory nodule (AN) count with no increase in abscess count and no increase in draining fistula count relative to Baseline.
Secondary Outcome Measures
Percentage of Participants Achieving Hidradenitis Suppurative Clinical Response (HiSCR) 75
HiSCR 75 is defined as at least a 75% reduction in the total abscess and inflammatory nodule (AN) count with no increase in abscess count and no increase in draining fistula count relative to Baseline.
Percentage of Participants Achieving Numeric Rating Scale 30 (NRS30) at Week 4 Among Subjects with NRS ≥ 3 at Baseline
Achievement will be considered at least a 30% reduction and at least 2 units reduction from Baseline in NRS scale in the Patient's Global Assessment (PGA) of HS-related skin pain based on worst skin pain in a 24-hour recall period (maximal daily pain). The PGA Skin Pain is an 11-point numerical rating scale with ratings for the item ranging from 0 (no skin pain) to 10 (skin pain as bad as you can imagine).
Incidence of Hidradenitis Suppurativa (HS) Flare During Period 1
Defined as at least one occurrence of a ≥ 25% increase in AN count, with a minimum absolute increase of 2 relative to Baseline.
Change from Baseline in Hidradenitis Suppurativa Symptom Assessment (HSSA)
The HSSA (24-hour recall) is a 9-item PRO questionnaire developed to assess the primary symptoms of HS in the 7 consecutive days prior to assessments. Each item of the HSSA is scored on an 11-point (0 to 10) NRS, where 0 represents no symptoms and 10 represents extreme symptom experience.
Change from Baseline in Hidradenitis Suppurativa Impact Assessment (HSIA)
The HSIA is an 18-item PRO questionnaire developed to assess the impact of HS on the daily lives of subjects in the 7 days prior to the assessment. Items 1 - 16 of the HSIA are scored on a 0 to 10 NRS, where 0 represents no impact and 10 represents extreme impact.
Change from Baseline in Dermatology Life Quality Index (DLQI) for Adult Subjects and Adolescent Subjects Age 17 Years Old or Children's DLQI (CDLQI) for Adolescent Subjects Ages 12 to 16 Years Old
The DLQI and the CDLQI are both 10-item questionnaires used to assess the impact of hidradenitis suppurativa (HS) disease symptoms and treatment on quality of life that consists of 10 questions scored on a 4-point scale where 0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much.
Change from Baseline in Hidradenitis Suppurativa (HS)-Related Odor, Based on Hidradenitis Suppurativa Symptom Assessment (HSSA) Question 8
The HSSA (24-hour recall) is a 9-item PRO questionnaire developed to assess the primary symptoms of HS in the 7 consecutive days prior to assessments. Each item of the HSSA is scored on an 11-point (0 to 10) NRS, where 0 represents no symptoms and 10 represents extreme symptom experience.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05889182
Brief Title
A Study to Assess Change in Disease Activity and Adverse Events of Oral Upadacitinib in Adult and Adolescent Participants With Moderate to Severe Hidradenitis Suppurativa Who Have Failed Anti-TNF Therapy
Acronym
Step-Up HS
Official Title
A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Efficacy and Safety of Upadacitinib in Adult and Adolescent Subjects With Moderate to Severe Hidradenitis Suppurativa Who Have Failed Anti-TNF Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 21, 2023 (Actual)
Primary Completion Date
November 24, 2025 (Anticipated)
Study Completion Date
August 1, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Hidradenitis suppurativa (HS) is an inflammatory skin disease that causes painful lesions in the axilla (underarm), inguinal (groin) and anogenital (anal/genital) regions. This study will assess how safe and effective upadacitinib is in treating adult and adolescent participants with moderate to severe HS who have failed to respond to or are intolerant of anti-tumor necrosis factor (TNF) therapy. Adverse events and change in disease activity will be assessed.
Upadacitinib is an approved drug for ulcerative colitis, atopic dermatitis, rheumatoid arthritis, psoriatic arthritis, and axial spondylarthritis and is being developed for the treatment of HS. This study is "double-blinded", meaning that neither the trial participants nor the study doctors will know who will be given upadacitinib and who will be given placebo. This study is comprised of 3 periods. In Period 1, participants are randomized into 2 groups called treatment arms where each group receives a different treatment. There is a 1 in 2 chance that participants will be assigned to placebo. In Period 2, participants are placed into 6 different groups depending on their placement and results in Period 1. Period 3 is the long-term extension period where participants will continue treatment from Period 2. Approximately 1328 adult and adolescent participants diagnosed with HS will be enrolled in approximately 275 sites worldwide.
Participants will receive oral tablets of upadacitinib or placebo once daily for 36 weeks in Period 1 and Period 2. Eligible participants from Period 1 and Period 2 will enter Period 3 and receive oral tablets of upadacitinib or placebo once daily for 68 weeks. Participants will be followed up for approximately 30 days.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular outpatient visits during the study. The effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hidradenitis Suppurativa
Keywords
Hidradenitis Suppurativa, Upadacitinib, ABT-494, Rinvoq, STEP-UP HS
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1328 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Period 1: Upadacitinib Dose A
Arm Type
Experimental
Arm Description
Participants will receive Upadicitinib Dose A once daily for 16 weeks.
Arm Title
Period 1: Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive Placebo once daily for 16 weeks.
Arm Title
Period 2: Group 1 - Upadacitinib Dose A
Arm Type
Experimental
Arm Description
Participants who were randomized to placebo in Period 1 who did not achieve HiSCR 50 (clinical non-responder, CNR) at Week 16 will receive Upadacitinib Dose A once daily for 20 weeks.
Arm Title
Period 2: Group 2 - Placebo
Arm Type
Placebo Comparator
Arm Description
Participants who were randomized to placebo in Period 1 who achieve HiSCR 50 (clinical responder, CR) at Week 16 will continue to receive placebo once daily for 20 weeks.
Arm Title
Period 2: Group 3 - Upadacitinib Dose A
Arm Type
Experimental
Arm Description
Participants who were randomized to upadacitinib Dose A in Period 1 who did not achieve HiSCR 50 (CNR) at Week 16 will continue to receive upadacitinib Dose A once daily for 20 weeks.
Arm Title
Period 2: Group 4 - Upadacitinib Dose A
Arm Type
Experimental
Arm Description
Participants who were randomized to upadacitinib Dose A in Period 1 who achieve HiSCR 50 (CR) at Week 16 will receive upadacitinib Dose A once daily for 20 weeks.
Arm Title
Period 2: Group 5 - Upadacitinib Dose B
Arm Type
Experimental
Arm Description
Participants who were randomized to upadacitinib Dose A in Period 1 who achieve HiSCR 50 (CR) at Week 16 will receive upadacitinib Dose B once daily for 20 weeks.
Arm Title
Period 2: Group 6 - Placebo
Arm Type
Experimental
Arm Description
Participants who were randomized to upadacitinib Dose A in Period 1 who achieve HiSCR 50 (CR) at Week 16 will receive placebo once daily for 20 weeks.
Arm Title
Period 3: Long-Term Extension
Arm Type
Experimental
Arm Description
Eligible participants will continue to receive upadacitinib or placebo for 68 weeks. Participants will be followed-up for approximately 30 days.
Intervention Type
Drug
Intervention Name(s)
Upadacitinib
Other Intervention Name(s)
ABT-494, RINVOQ
Intervention Description
Oral Tablets
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral Tablets
Primary Outcome Measure Information:
Title
Percentage of Participants Achieving Hidradenitis Suppurative Clinical Response (HiSCR) 50
Description
HiSCR 50 is defined as at least a 50% reduction in the total abscess and inflammatory nodule (AN) count with no increase in abscess count and no increase in draining fistula count relative to Baseline.
Time Frame
Baseline to Week 16
Secondary Outcome Measure Information:
Title
Percentage of Participants Achieving Hidradenitis Suppurative Clinical Response (HiSCR) 75
Description
HiSCR 75 is defined as at least a 75% reduction in the total abscess and inflammatory nodule (AN) count with no increase in abscess count and no increase in draining fistula count relative to Baseline.
Time Frame
Baseline to Week 16
Title
Percentage of Participants Achieving Numeric Rating Scale 30 (NRS30) at Week 4 Among Subjects with NRS ≥ 3 at Baseline
Description
Achievement will be considered at least a 30% reduction and at least 2 units reduction from Baseline in NRS scale in the Patient's Global Assessment (PGA) of HS-related skin pain based on worst skin pain in a 24-hour recall period (maximal daily pain). The PGA Skin Pain is an 11-point numerical rating scale with ratings for the item ranging from 0 (no skin pain) to 10 (skin pain as bad as you can imagine).
Time Frame
Baseline to Week 4
Title
Incidence of Hidradenitis Suppurativa (HS) Flare During Period 1
Description
Defined as at least one occurrence of a ≥ 25% increase in AN count, with a minimum absolute increase of 2 relative to Baseline.
Time Frame
Week 16
Title
Change from Baseline in Hidradenitis Suppurativa Symptom Assessment (HSSA)
Description
The HSSA (24-hour recall) is a 9-item PRO questionnaire developed to assess the primary symptoms of HS in the 7 consecutive days prior to assessments. Each item of the HSSA is scored on an 11-point (0 to 10) NRS, where 0 represents no symptoms and 10 represents extreme symptom experience.
Time Frame
Baseline to Week 16
Title
Change from Baseline in Hidradenitis Suppurativa Impact Assessment (HSIA)
Description
The HSIA is an 18-item PRO questionnaire developed to assess the impact of HS on the daily lives of subjects in the 7 days prior to the assessment. Items 1 - 16 of the HSIA are scored on a 0 to 10 NRS, where 0 represents no impact and 10 represents extreme impact.
Time Frame
Baseline to Week 16
Title
Change from Baseline in Dermatology Life Quality Index (DLQI) for Adult Subjects and Adolescent Subjects Age 17 Years Old or Children's DLQI (CDLQI) for Adolescent Subjects Ages 12 to 16 Years Old
Description
The DLQI and the CDLQI are both 10-item questionnaires used to assess the impact of hidradenitis suppurativa (HS) disease symptoms and treatment on quality of life that consists of 10 questions scored on a 4-point scale where 0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much.
Time Frame
Baseline to Week 16
Title
Change from Baseline in Hidradenitis Suppurativa (HS)-Related Odor, Based on Hidradenitis Suppurativa Symptom Assessment (HSSA) Question 8
Description
The HSSA (24-hour recall) is a 9-item PRO questionnaire developed to assess the primary symptoms of HS in the 7 consecutive days prior to assessments. Each item of the HSSA is scored on an 11-point (0 to 10) NRS, where 0 represents no symptoms and 10 represents extreme symptom experience.
Time Frame
Baseline to Week 16
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of HS for at least 6 months prior to Baseline, as determined by the investigator (i.e., through medical history and interview of subject).
Documented history of previous use of ≥ 1 TNF inhibitor for HS for at least 12 weeks and/or 1 approved non-anti-TNF biologic therapy for HS for at least 16 weeks characterized by inadequate response or for any duration characterized by intolerance as determined by the investigator.
Participant must have a total AN count of ≥ 5 at Baseline.
HS lesions must be present in at least 2 distinct anatomic areas at Baseline.
At least 1 anatomic area of HS involvement characterized as Hurley Stage II or higher at Baseline.
Draining fistula count of ≤ 20 at Baseline.
Exclusion Criteria:
History of active skin disease other than HS that could interfere with the assessment of HS, including skin infections (bacterial, fungal, or viral) requiring systemic treatment within 4 weeks of the Baseline visit.
Treatment with any investigational drug of chemical or biologic nature within a minimum of 30 days or 5 half-lives (whichever is longer) prior to the first dose of study drug or be currently enrolled in another interventional clinical study. Investigational drugs are also prohibited during the study.
Previous treatment with any cell-depleting therapies including but not limited to anti-CD20 (e.g., rituximab) within 12 months prior to Baseline or until B cell count returns to normal level or pre-treatment level.
Use of prescription topical therapies (including topical antibiotics) that can also be used to treat HS within 14 days prior to the Baseline visit.
Received any systemic (including oral) antibiotic treatment for HS or any other chronic inflammatory disorder within 14 days prior to the Baseline visit.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ABBVIE CALL CENTER
Phone
844-663-3742
Email
abbvieclinicaltrials@abbvie.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Cahaba Dermatology Skin Health Center /ID# 254876
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35244
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
205-778-1564
Facility Name
Medical Dermatology Specialist /ID# 254226
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006-2722
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
602-354-5770
Facility Name
Clinical Trials Institute at Northwest Arkansas /ID# 254924
City
Fayetteville
State/Province
Arkansas
ZIP/Postal Code
72703-6245
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
479-544-3483
Facility Name
Burke Pharmaceutical Research /ID# 254238
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913-6404
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
501-620-4449
Facility Name
Arkansas Research Trials, LLC /ID# 254233
City
North Little Rock
State/Province
Arkansas
ZIP/Postal Code
72117
Country
United States
Individual Site Status
Recruiting
Facility Name
NW Arkansas Clinical Trials Center /ID# 254311
City
Rogers
State/Province
Arkansas
ZIP/Postal Code
72758
Country
United States
Individual Site Status
Recruiting
Facility Name
T. Joseph Raoof, MD, Inc. /ID# 254374
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
Site Coordinator
Phone
818-714-1431
Facility Name
Dermatology Research Associates /ID# 254846
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
310-337-7171
Facility Name
Integrative Skin Science and Research /ID# 254930
City
Sacramento
State/Province
California
ZIP/Postal Code
95815
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Trials Research Institute /ID# 254466
City
Thousand Oaks
State/Province
California
ZIP/Postal Code
91320-2130
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
805-298-7021
Facility Name
Skin Care Research - Boca Raton /ID# 253814
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486-2269
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
+1-561-948-3116
Facility Name
Apex Clinical Trials /ID# 255756
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
+1-813-321-1786
Facility Name
Florida Academic Centers Research and Education /ID# 254011
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
954-743-0747
Facility Name
Skin Care Research - Hollywood /ID# 254508
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021-6748
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
+1-561-948-3116
Facility Name
Advanced Clinical Research Institute /ID# 253746
City
Tampa
State/Province
Florida
ZIP/Postal Code
33602
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
+1-813-879-7546
Facility Name
Skin Care Research - Tampa /ID# 256440
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607-6438
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
561-948-3116
Facility Name
Avita Clinical Research /ID# 254471
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613-1825
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
+1-813-603-1800
Facility Name
Centricity Research /ID# 255470
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904-2954
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
706-321-0495
Facility Name
Treasure Valley Medical Research /ID# 255208
City
Boise
State/Province
Idaho
ZIP/Postal Code
83706
Country
United States
Individual Site Status
Recruiting
Facility Name
DeNova Research /ID# 254372
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Name
Northshore University Health System Dermatology Clinical Trials Unit /ID# 254389
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60077
Country
United States
Individual Site Status
Recruiting
Facility Name
Dawes Fretzin, LLC /ID# 254390
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46256
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
317-516-5030 X102
Facility Name
Michigan Dermatology Institute /ID# 254468
City
Waterford
State/Province
Michigan
ZIP/Postal Code
48328-3277
Country
United States
Individual Site Status
Recruiting
Facility Name
MediSearch Clinical Trials /ID# 254392
City
Saint Joseph
State/Province
Missouri
ZIP/Postal Code
64506
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
816-364-1515
Facility Name
Vivida Dermatology- Flamingo /ID# 254227
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119-5190
Country
United States
Individual Site Status
Recruiting
Facility Name
Skin Cancer and Dermatology Institute (SCDI) /ID# 254410
City
Reno
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Individual Site Status
Recruiting
Facility Name
Onsite Clinical Solutions /ID# 254854
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28277-3816
Country
United States
Individual Site Status
Recruiting
Facility Name
ClinOhio Research Services /ID# 254851
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213-4440
Country
United States
Individual Site Status
Recruiting
Facility Name
Dermatologists of Southwest Ohio, Inc /ID# 254297
City
Mason
State/Province
Ohio
ZIP/Postal Code
45040-4520
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
513-701-5526
Facility Name
Lynn Health Science Institute (LHSI) /ID# 253791
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
(405) 602-3916
Facility Name
Arlington Research Center, Inc /ID# 253805
City
Arlington
State/Province
Texas
ZIP/Postal Code
76011
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
817-795-7546
Facility Name
Bellaire Dermatology Associates /ID# 253797
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
832-331-7070
Facility Name
Dermatology Treatment and Research Center /ID# 253795
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Individual Site Status
Recruiting
Facility Name
Modern Research Associates, PLLC /ID# 253810
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Individual Site Status
Recruiting
Facility Name
HRMD Research Dallas /ID# 255256
City
Dallas
State/Province
Texas
ZIP/Postal Code
75240-6246
Country
United States
Individual Site Status
Recruiting
Facility Name
Suzanne Bruce and Associates-Houston /ID# 254228
City
Houston
State/Province
Texas
ZIP/Postal Code
77056
Country
United States
Individual Site Status
Recruiting
Facility Name
Texas Dermatology Research Center, LLC /ID# 254928
City
Plano
State/Province
Texas
ZIP/Postal Code
75025
Country
United States
Individual Site Status
Recruiting
Facility Name
Center for Clinical Studies - Webster TX /ID# 254242
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
281-343-3300
Facility Name
The Education & Research Foundation, Inc. /ID# 254852
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24501-1403
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
(434) 847-8400
Facility Name
Virginia Clinical Research, Inc. /ID# 254538
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
757-625-0151
Facility Name
Premier Clinical Research /ID# 254847
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Individual Site Status
Recruiting
Facility Name
Fukuoka University Hospital /ID# 254729
City
Fukuoka-shi
State/Province
Fukuoka
ZIP/Postal Code
814-0180
Country
Japan
Individual Site Status
Recruiting
Facility Name
Meiwa Hospital /ID# 254728
City
Nishinomiya-shi
State/Province
Hyogo
ZIP/Postal Code
663-8186
Country
Japan
Individual Site Status
Recruiting
Facility Name
University Hospital Kyoto Prefectural University of Medicine /ID# 254481
City
Kyoto-shi
State/Province
Kyoto
ZIP/Postal Code
602-8566
Country
Japan
Individual Site Status
Recruiting
Facility Name
University of the Ryukyus Hospital /ID# 254517
City
Nakagami-gun
State/Province
Okinawa
ZIP/Postal Code
903-0215
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kindai University Hospital /ID# 254574
City
Osakasayama-shi
State/Province
Osaka
ZIP/Postal Code
589-8511
Country
Japan
Individual Site Status
Recruiting
Facility Name
Toranomon Hospital /ID# 253819
City
Minato-ku
State/Province
Tokyo
ZIP/Postal Code
105-8470
Country
Japan
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
IPD Sharing Time Frame
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
IPD Sharing Access Criteria
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
IPD Sharing URL
https://vivli.org/ourmember/abbvie/
Links:
URL
https://www.abbvieclinicaltrials.com/study/?id=M23-698
Description
Related Info
Learn more about this trial
A Study to Assess Change in Disease Activity and Adverse Events of Oral Upadacitinib in Adult and Adolescent Participants With Moderate to Severe Hidradenitis Suppurativa Who Have Failed Anti-TNF Therapy
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