Psoriasis Clinical 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

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.

View Full Description

Full 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.

View Eligibility Criteria

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.

Study is for people with:

Psoriasis

Phase:

Phase 2

Estimated Enrollment:

68

Study ID:

NCT04430855

Recruitment Status:

Completed

Sponsor:

AbbVie

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 26 Locations for this study

See Locations Near You

Medical Dermatology Specialist /ID# 221084
Phoenix Arizona, 85006, United States
University of Arkansas for Medical Sciences /ID# 218404
Little Rock Arkansas, 72205, United States
Medderm Associates /ID# 218317
San Diego California, 92103, United States
Skin Care Research - Boca Raton /ID# 218809
Boca Raton Florida, 33486, United States
Lakes Research, LLC /ID# 218854
Miami Florida, 33014, United States
ForCare Clinical Research /ID# 218013
Tampa Florida, 33613, United States
Northshore University Health System Dermatology Clinical Trials Unit /ID# 218319
Skokie Illinois, 60077, United States
Dawes Fretzin, LLC /ID# 218310
Indianapolis Indiana, 46256, United States
Beth Israel Deaconess Medical Center /ID# 218306
Boston Massachusetts, 02215, United States
Washington University-School of Medicine /ID# 218331
Saint Louis Missouri, 63110, United States
Psoriasis Treatment Center of Central New Jersey /ID# 218330
East Windsor New Jersey, 08520, United States
Duke Cancer Center /ID# 218526
Durham North Carolina, 27710, United States
University Hospitals Case Medical Center /ID# 218326
Cleveland Ohio, 44106, United States
Southside Dermatology /ID# 218321
Tulsa Oklahoma, 74132, United States
University of Pittsburgh MC /ID# 218329
Pittsburgh Pennsylvania, 15260, United States
Medical University of South Carolina /ID# 218318
Charleston South Carolina, 29425, United States
Duplicate_Center for Clinical Studies /ID# 218307
Houston Texas, 77004, United States
Dermatology Specialists of Spokane /ID# 218760
Spokane Washington, 99202, United States
Dermatology Research Institute Inc. /ID# 218780
Calgary Alberta, T2J 7, Canada
Winnipeg Clinic /ID# 218963
Winnipeg Manitoba, R3C 0, Canada
Dr. Wei Jing Loo Medicine Prof /ID# 218779
London Ontario, N6H 5, Canada
Lynderm Research Inc. /ID# 218778
Markham Ontario, L3P 1, Canada
Takagi Dermatology Clinic /ID# 218587
Obihiro-shi Hokkaido, 080-0, Japan
University Hospital Kyoto Prefectural University of Medicine /ID# 220859
Kyoto-shi Kyoto, 602-8, Japan
Toranomon Hospital /ID# 218588
Minato-ku Tokyo, 105-8, Japan
Cruz-Santana, Carolina, PR /ID# 221188
Carolina , 00985, Puerto Rico

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 2

Estimated Enrollment:

68

Study ID:

NCT04430855

Recruitment Status:

Completed

Sponsor:


AbbVie

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.