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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|ClinicalTrials.gov Identifier: NCT04430855|
Recruitment Status : Recruiting
First Posted : June 12, 2020
Last Update Posted : November 6, 2020
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 (HS) in adult participants with moderate to severe disease. The study will assess change in disease signs and symptoms.
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. Adult participants with a diagnosis of hidradenitis suppurativa will be enrolled. Around 60 participants will be enrolled in the study in approximately 28 sites globally.
Participants will undergo approximately 35-days of screening followed by oral tablet upadacitinib or placebo once daily for 48 weeks and a 30-day follow-up visit after the last dose of study drug for a total study duration of up to 57 weeks.
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.
|Condition or disease||Intervention/treatment||Phase|
|Hidradenitis Suppurativa (HS)||Drug: Upadacitinib Drug: Placebo Upadacitinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Upadacitinib in Adult Subjects With Moderate to Severe Hidradenitis Suppurativa|
|Actual Study Start Date :||July 14, 2020|
|Estimated Primary Completion Date :||June 17, 2021|
|Estimated Study Completion Date :||March 30, 2022|
Experimental: Upadacitinib Dose A
Participants will receive Upadacitinib Dose A for 12 weeks (Period 1) followed by Upadacitinib Dose A for 36 weeks (Period 2).
Other Name: RINVOQ
Experimental: Placebo followed by Upadacitinib Dose B
Participants will receive placebo for 12 weeks (Period 1) followed by Upadacitinib Dose B for 36 weeks (Period 2).
Other Name: RINVOQ
Drug: Placebo Upadacitinib
- Percentage of participants achieving Hidradenitis Suppurativa Clinical Response (HiSCR) [ Time Frame: 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.
- Percentage of Participants Achieving Skin Pain Numeric Rating Scale 30 (NRS30) [ Time Frame: Week 12 ]The Patient's Global Assessment of Skin Pain Numeric Rating Scale (NRS) assesses the worst skin pain and the average skin pain due to HS. The percentage of participants who achieved at least 30% reduction and at least 1 unit reduction from Baseline in the Patient's Global Assessment of Skin Pain (NRS30) - at worst in participants with NRS >=3 at Baseline are assessed.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04430855
|Contact: ABBVIE CALL CENTERemail@example.com|
|Study Director:||AbbVie Inc.||AbbVie|