Clinical Trials Logo
  1. Home
  2. Hidradenitis Suppurativa (HS)
  3. NCT04430855

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 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04430855
Study type Interventional
Source AbbVie
Contact
Status Completed
Phase Phase 2
Start date July 14, 2020
Completion date January 25, 2022
View Details
See also
  Status Clinical Trial Phase
Completed NCT03173144 - Chronic Inflammatory Disease, Lifestyle and Treatment Response
Completed NCT02896920 - Canadian Humira Post Marketing Observational Epidemiological Study : Assessing Humira Real-life Effectiveness and Impact on HS Burden of Illness
Completed NCT01468233 - Efficacy and Safety Study of Adalimumab in the Treatment of Hidradenitis Suppurativa Phase 3
Completed NCT01468207 - Efficacy and Safety Study of Adalimumab in Treatment of Hidradenitis Suppurativa Phase 3
Completed NCT03894956 - Observational Study Evaluating Long-Term Safety and Effectiveness of Humira in Patients With Hidradenitis Suppurativa
Completed NCT03001115 - Post-Marketing Surveillance of Adalimumab in Korean Hidradenitis Suppurativa Subjects
Not yet recruiting NCT05723757 - Autophagy Dysfunction in Hidradenitis Suppurativa N/A
Completed NCT02808975 - Safety and Efficacy of Adalimumab (Humira) for Hidradenitis Suppurativa (HS) Peri-Surgically Phase 4
Recruiting NCT06212999 - A Study to Evaluate the Long-Term Safety and Efficacy of Povorcitinib in Participants With Moderate to Severe Hidradenitis Suppurativa Phase 3
Active, not recruiting NCT04354012 - Hidradenitis Suppurativa Wound Care Phase 2
Completed NCT03487276 - Efficacy and Safety Study of IFX-1 in Patients With Moderate to Severe Hidradenitis Suppurativa (HS) Phase 2
Recruiting NCT05620836 - A Study to Evaluate the Efficacy and Safety of Povorcitinib (INCB054707) in Participants With Moderate to Severe Hidradenitis Suppurativa (HS) Phase 3
Not yet recruiting NCT05735925 - The Role of Host-microbiota Interplay in Hidradenitis Suppurativa Pathogenesis N/A
Recruiting NCT05620823 - A Study to Evaluate the Efficacy and Safety of Povorcitinib (INCB054707) in Participants With Moderate to Severe Hidradenitis Suppurativa Phase 3
Not yet recruiting NCT06241573 - A Study to Test Long-term Treatment With Spesolimab in People With a Skin Condition Disease Called Hidradenitis Suppurativa (HS) Who Took Part in a Previous Study With Spesolimab Phase 2/Phase 3
Available NCT05583604 - Secukinumab Global MAP Cohort for Adult Patients With Hidradenitis Suppurativa (HS)