A Study of Oral Upadacitinib Tablet Compared to Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa to Assess Change in Disease Symptoms
Primary Purpose
Hidradenitis Suppurativa (HS)
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Upadacitinib
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hidradenitis Suppurativa (HS) focused on measuring Hidradenitis suppurativa (HS), Upadacitinib
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of hidradenitis suppurativa (HS) for at least 1 year prior to Baseline.
- Total abscess and inflammatory nodule (AN) count of >= 5 at Baseline, presence of HS lesions in at least 2 distinct anatomical areas, and draining fistula count of <=20 at Baseline.
- History of inadequate response or an intolerance to adequate trial of oral antibiotics for treatment of HS.
- Required to use a daily antiseptic wash on HS lesions.
Exclusion Criteria:
- History of active skin disease (other than HS) that could interfere with assessment of HS, including skin infections requiring systemic treatment within 4 weeks of the Baseline visit.
Sites / Locations
- Medical Dermatology Specialist /ID# 221084
- University of Arkansas for Medical Sciences /ID# 218404
- Medderm Associates /ID# 218317
- Skin Care Research - Boca Raton /ID# 218809
- Lakes Research, LLC /ID# 218854
- ForCare Clinical Research /ID# 218013
- Northshore University Health System Dermatology Clinical Trials Unit /ID# 218319
- Dawes Fretzin, LLC /ID# 218310
- Beth Israel Deaconess Medical Center /ID# 218306
- Washington University-School of Medicine /ID# 218331
- Psoriasis Treatment Center of Central New Jersey /ID# 218330
- Duke Cancer Center /ID# 218526
- University Hospitals Case Medical Center /ID# 218326
- Southside Dermatology /ID# 218321
- University of Pittsburgh MC /ID# 218329
- Medical University of South Carolina /ID# 218318
- Duplicate_Center for Clinical Studies /ID# 218307
- Dermatology Specialists of Spokane /ID# 218760
- Dermatology Research Institute Inc. /ID# 218780
- Winnipeg Clinic /ID# 218963
- Dr. Wei Jing Loo Medicine Prof /ID# 218779
- Lynderm Research Inc. /ID# 218778
- Takagi Dermatology Clinic /ID# 218587
- University Hospital Kyoto Prefectural University of Medicine /ID# 220859
- Toranomon Hospital /ID# 218588
- Cruz-Santana, Carolina, PR /ID# 221188
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Upadacitinib 30 mg
Placebo followed by Upadacitinib 15 mg
Arm Description
Participants will receive 30 mg upadacitinib orally once a day for 12 weeks (Period 1) followed by 30 mg upadacitinib orally once a day for 36 weeks (Period 2).
Participants will receive matching placebo orally once a day for 12 weeks (Period 1) followed by 15 mg upadacitinib orally once a day for 36 weeks (Period 2).
Outcomes
Primary Outcome Measures
Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12
HiSCR 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 PGA Skin Pain Numeric Rating Scale 30 (NRS30) Response at Week 12 Among Participants With Baseline NRS ≥ 3
The Patient's Global Assessment (PGA) of Skin Pain Numeric Rating Scale (NRS) was used to assess the worst skin pain due to HS. Participants were asked to rate their worst skin pain in the last 24 hours on an 11-point numerical rating scale ranging from 0 (no skin pain) to 10 (skin pain as bad as you can imagine) on a daily basis using an electronic diary. The weekly average score was calculated based on the daily scores from the 7 days prior to the visit (with non-missing values in 4 or more days of the 7 day period).
NRS30 is defined as the percentage of participants who achieved at least a 30% reduction and at least 1 unit reduction from Baseline in the PGA of skin pain NRS in participants with Baseline skin pain NRS ≥ 3.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04430855
Brief Title
A Study of Oral Upadacitinib Tablet Compared to Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa to Assess Change in Disease Symptoms
Official Title
A Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Upadacitinib in Adult Subjects With Moderate to Severe Hidradenitis Suppurativa
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
July 14, 2020 (Actual)
Primary Completion Date
April 22, 2021 (Actual)
Study Completion Date
January 25, 2022 (Actual)
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.
Yes
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 and genital) regions. This study will evaluate how well upadacitinib compared to placebo (no medicine) works to treat hidradenitis suppurativa in adult participants with moderate to severe disease. The study will assess change in disease signs and symptoms.
Detailed Description
Upadacitinib is an investigational drug being developed for the treatment of HS. This study is "double-blinded," which means that neither the trial participants nor the study doctors will know who will be given study drug and who will receive placebo (no medicine). Participants are randomly (by chance) put into 1 of 2 groups, called treatment arms. They are randomized in a 2 to 1 ratio meaning more participants have a chance to receive upadacitinib compared to placebo.
Participants will undergo approximately 35-days of screening followed by a 48-week treatment period and a 30-day follow-up visit after the last dose of study drug for a total study duration of up to 57 weeks. The treatment period will consist of a 12-week placebo-controlled, double-blind period (Period 1) and a 36-week blinded extension period (Period 2).
There may be a higher burden for participants in this trial compared to their standard of care. Participants will attend visits every other week, once a month, or once every 2 months during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, 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 (HS)
Keywords
Hidradenitis suppurativa (HS), Upadacitinib
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
68 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Upadacitinib 30 mg
Arm Type
Experimental
Arm Description
Participants will receive 30 mg upadacitinib orally once a day for 12 weeks (Period 1) followed by 30 mg upadacitinib orally once a day for 36 weeks (Period 2).
Arm Title
Placebo followed by Upadacitinib 15 mg
Arm Type
Experimental
Arm Description
Participants will receive matching placebo orally once a day for 12 weeks (Period 1) followed by 15 mg upadacitinib orally once a day for 36 weeks (Period 2).
Intervention Type
Drug
Intervention Name(s)
Upadacitinib
Other Intervention Name(s)
RINVOQ
Intervention Description
Tablet; Oral
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Tablet; Oral
Primary Outcome Measure Information:
Title
Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12
Description
HiSCR 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 and Week 12
Secondary Outcome Measure Information:
Title
Percentage of Participants Achieving PGA Skin Pain Numeric Rating Scale 30 (NRS30) Response at Week 12 Among Participants With Baseline NRS ≥ 3
Description
The Patient's Global Assessment (PGA) of Skin Pain Numeric Rating Scale (NRS) was used to assess the worst skin pain due to HS. Participants were asked to rate their worst skin pain in the last 24 hours on an 11-point numerical rating scale ranging from 0 (no skin pain) to 10 (skin pain as bad as you can imagine) on a daily basis using an electronic diary. The weekly average score was calculated based on the daily scores from the 7 days prior to the visit (with non-missing values in 4 or more days of the 7 day period).
NRS30 is defined as the percentage of participants who achieved at least a 30% reduction and at least 1 unit reduction from Baseline in the PGA of skin pain NRS in participants with Baseline skin pain NRS ≥ 3.
Time Frame
Baseline and Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of hidradenitis suppurativa (HS) for at least 1 year prior to Baseline.
Total abscess and inflammatory nodule (AN) count of ≥ 5 at Baseline, presence of HS lesions in at least 2 distinct anatomical areas, and draining fistula count of ≤ 20 at Baseline.
History of inadequate response or an intolerance to adequate trial of oral antibiotics for treatment of HS.
Required to use a daily antiseptic wash on HS lesions.
Exclusion Criteria:
-History of active skin disease (other than HS) that could interfere with assessment of HS, including skin infections requiring systemic treatment within 4 weeks of the Baseline visit.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Medical Dermatology Specialist /ID# 221084
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006-2722
Country
United States
Facility Name
University of Arkansas for Medical Sciences /ID# 218404
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Medderm Associates /ID# 218317
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Skin Care Research - Boca Raton /ID# 218809
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486-2269
Country
United States
Facility Name
Lakes Research, LLC /ID# 218854
City
Miami
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
ForCare Clinical Research /ID# 218013
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613-1244
Country
United States
Facility Name
Northshore University Health System Dermatology Clinical Trials Unit /ID# 218319
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60077
Country
United States
Facility Name
Dawes Fretzin, LLC /ID# 218310
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46256
Country
United States
Facility Name
Beth Israel Deaconess Medical Center /ID# 218306
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215-5400
Country
United States
Facility Name
Washington University-School of Medicine /ID# 218331
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Psoriasis Treatment Center of Central New Jersey /ID# 218330
City
East Windsor
State/Province
New Jersey
ZIP/Postal Code
08520
Country
United States
Facility Name
Duke Cancer Center /ID# 218526
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710-3000
Country
United States
Facility Name
University Hospitals Case Medical Center /ID# 218326
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Southside Dermatology /ID# 218321
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74132
Country
United States
Facility Name
University of Pittsburgh MC /ID# 218329
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15260
Country
United States
Facility Name
Medical University of South Carolina /ID# 218318
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Duplicate_Center for Clinical Studies /ID# 218307
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Dermatology Specialists of Spokane /ID# 218760
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Facility Name
Dermatology Research Institute Inc. /ID# 218780
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2J 7E1
Country
Canada
Facility Name
Winnipeg Clinic /ID# 218963
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3C 0N2
Country
Canada
Facility Name
Dr. Wei Jing Loo Medicine Prof /ID# 218779
City
London
State/Province
Ontario
ZIP/Postal Code
N6H 5L5
Country
Canada
Facility Name
Lynderm Research Inc. /ID# 218778
City
Markham
State/Province
Ontario
ZIP/Postal Code
L3P 1X2
Country
Canada
Facility Name
Takagi Dermatology Clinic /ID# 218587
City
Obihiro-shi
State/Province
Hokkaido
ZIP/Postal Code
080-0013
Country
Japan
Facility Name
University Hospital Kyoto Prefectural University of Medicine /ID# 220859
City
Kyoto-shi
State/Province
Kyoto
ZIP/Postal Code
602-8566
Country
Japan
Facility Name
Toranomon Hospital /ID# 218588
City
Minato-ku
State/Province
Tokyo
ZIP/Postal Code
105-8470
Country
Japan
Facility Name
Cruz-Santana, Carolina, PR /ID# 221188
City
Carolina
ZIP/Postal Code
00985
Country
Puerto Rico
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.rxabbvie.com/
Description
This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.
Learn more about this trial
A Study of Oral Upadacitinib Tablet Compared to Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa to Assess Change in Disease Symptoms
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