A Study of Oral Upadacitinib Tablet Compared to Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa to Assess Change in Disease Symptoms

Hidradenitis Suppurativa (HS) Clinical Trial

Official title:

A Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Upadacitinib in Adult Subjects With Moderate to Severe Hidradenitis Suppurativa

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04430855
• Other study ID #: M20-040
• Status: Completed
• Phase: Phase 2
• Start date: July 14, 2020
• Est. completion date: January 25, 2022

Study information

• Verified date: January 2023
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: January 25, 2022
• Est. primary completion date: April 22, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hidradenitis
• Hidradenitis Suppurativa
• Hidradenitis Suppurativa (HS)

Intervention

Drug:
• Upadacitinib
Tablet; Oral
• Placebo
Tablet; Oral

Locations

Country	Name	City	State
Canada	Dermatology Research Institute Inc. /ID# 218780	Calgary	Alberta
Canada	Dr. Wei Jing Loo Medicine Prof /ID# 218779	London	Ontario
Canada	Lynderm Research Inc. /ID# 218778	Markham	Ontario
Canada	Winnipeg Clinic /ID# 218963	Winnipeg	Manitoba
Japan	University Hospital Kyoto Prefectural University of Medicine /ID# 220859	Kyoto-shi	Kyoto
Japan	Toranomon Hospital /ID# 218588	Minato-ku	Tokyo
Japan	Takagi Dermatology Clinic /ID# 218587	Obihiro-shi	Hokkaido
Puerto Rico	Cruz-Santana, Carolina, PR /ID# 221188	Carolina
United States	Skin Care Research - Boca Raton /ID# 218809	Boca Raton	Florida
United States	Beth Israel Deaconess Medical Center /ID# 218306	Boston	Massachusetts
United States	Medical University of South Carolina /ID# 218318	Charleston	South Carolina
United States	University Hospitals Case Medical Center /ID# 218326	Cleveland	Ohio
United States	Duke Cancer Center /ID# 218526	Durham	North Carolina
United States	Psoriasis Treatment Center of Central New Jersey /ID# 218330	East Windsor	New Jersey
United States	Duplicate_Center for Clinical Studies /ID# 218307	Houston	Texas
United States	Dawes Fretzin, LLC /ID# 218310	Indianapolis	Indiana
United States	University of Arkansas for Medical Sciences /ID# 218404	Little Rock	Arkansas
United States	Lakes Research, LLC /ID# 218854	Miami	Florida
United States	Medical Dermatology Specialist /ID# 221084	Phoenix	Arizona
United States	University of Pittsburgh MC /ID# 218329	Pittsburgh	Pennsylvania
United States	Washington University-School of Medicine /ID# 218331	Saint Louis	Missouri
United States	Medderm Associates /ID# 218317	San Diego	California
United States	Northshore University Health System Dermatology Clinical Trials Unit /ID# 218319	Skokie	Illinois
United States	Dermatology Specialists of Spokane /ID# 218760	Spokane	Washington
United States	ForCare Clinical Research /ID# 218013	Tampa	Florida
United States	Southside Dermatology /ID# 218321	Tulsa	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Canada,  Japan,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline and Week 12
Secondary	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.	Baseline and Week 12

External Links

•   This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.