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

NCT ID: NCT04430855

Last Updated: 2023-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-14
• Study Completion Date: 2022-01-25

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.

Conditions

Hidradenitis Suppurativa (HS)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Upadacitinib 30 mg

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).

Group Type: EXPERIMENTAL

Upadacitinib

Intervention Type: DRUG

Tablet; Oral

Placebo followed by Upadacitinib 15 mg

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).

Group Type: EXPERIMENTAL

Upadacitinib

Intervention Type: DRUG

Tablet; Oral

Placebo

Intervention Type: DRUG

Tablet; Oral

Interventions

Upadacitinib

Tablet; Oral

Intervention Type: DRUG

Placebo

Tablet; Oral

Intervention Type: DRUG

Other Intervention Names

RINVOQ

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AbbVie

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

ABBVIE INC.

Role: STUDY_DIRECTOR

AbbVie

Locations

Medical Dermatology Specialist /ID# 221084

Phoenix, Arizona, United States

University of Arkansas for Medical Sciences /ID# 218404

Little Rock, Arkansas, United States

Medderm Associates /ID# 218317

San Diego, California, United States

Skin Care Research - Boca Raton /ID# 218809

Boca Raton, Florida, United States

Lakes Research, LLC /ID# 218854

Miami, Florida, United States

ForCare Clinical Research /ID# 218013

Tampa, Florida, United States

Northshore University Health System Dermatology Clinical Trials Unit /ID# 218319

Skokie, Illinois, United States

Dawes Fretzin, LLC /ID# 218310

Indianapolis, Indiana, United States

Beth Israel Deaconess Medical Center /ID# 218306

Boston, Massachusetts, United States

Washington University-School of Medicine /ID# 218331

St Louis, Missouri, United States

Psoriasis Treatment Center of Central New Jersey /ID# 218330

East Windsor, New Jersey, United States

Duke Cancer Center /ID# 218526

Durham, North Carolina, United States

University Hospitals Case Medical Center /ID# 218326

Cleveland, Ohio, United States

Southside Dermatology /ID# 218321

Tulsa, Oklahoma, United States

University of Pittsburgh MC /ID# 218329

Pittsburgh, Pennsylvania, United States

Medical University of South Carolina /ID# 218318

Charleston, South Carolina, United States

Duplicate_Center for Clinical Studies /ID# 218307

Houston, Texas, United States

Dermatology Specialists of Spokane /ID# 218760

Spokane, Washington, United States

Dermatology Research Institute Inc. /ID# 218780

Calgary, Alberta, Canada

Winnipeg Clinic /ID# 218963

Winnipeg, Manitoba, Canada

Dr. Wei Jing Loo Medicine Prof /ID# 218779

London, Ontario, Canada

Lynderm Research Inc. /ID# 218778

Markham, Ontario, Canada

Takagi Dermatology Clinic /ID# 218587

Obihiro-shi, Hokkaido, Japan

University Hospital Kyoto Prefectural University of Medicine /ID# 220859

Kyoto, Kyoto, Japan

Toranomon Hospital /ID# 218588

Minato-ku, Tokyo, Japan

Cruz-Santana, Carolina, PR /ID# 221188

Carolina, , Puerto Rico

Countries

United States; Canada; Japan; Puerto Rico

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://www.rxabbvie.com/

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

Other Identifiers

M20-040

Identifier Type: -

Identifier Source: org_study_id