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

• ClinicalTrials.gov Identifier: NCT04430855
• Recruitment Status: Completed
• First Posted: June 12, 2020
• Results First Posted: February 6, 2023
• Last Update Posted: February 6, 2023
• Sponsor: AbbVie
• Information provided by (Responsible Party): AbbVie

Tracking Information

• First Submitted Date: June 11, 2020
• First Posted Date: June 12, 2020
• Results First Submitted Date: January 10, 2023
• Results First Posted Date: February 6, 2023
• Last Update Posted Date: February 6, 2023
• Actual Study Start Date: July 14, 2020
• Actual Primary Completion Date: April 22, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 10, 2023)

Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12 [ Time Frame: Baseline and 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.

Original Primary Outcome Measures (submitted: June 11, 2020)

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.

Current Secondary Outcome Measures (submitted: January 10, 2023)

Percentage of Participants Achieving PGA Skin Pain Numeric Rating Scale 30 (NRS30) Response at Week 12 Among Participants With Baseline NRS ≥ 3 [ Time Frame: Baseline and Week 12 ]

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.

Original Secondary Outcome Measures (submitted: June 11, 2020)

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.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study of Oral Upadacitinib Tablet Compared to Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa to Assess Change in Disease Symptoms
• Official Title: A Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Upadacitinib in Adult Subjects With Moderate to Severe Hidradenitis Suppurativa
• 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.

• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Hidradenitis Suppurativa (HS)

Intervention

• Drug: Upadacitinib
  Tablet; Oral
  Other Name: RINVOQ
• Drug: Placebo
  Tablet; Oral

Study Arms

• Experimental: 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).
  Intervention: Drug: Upadacitinib
• Experimental: 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).
  Interventions:

  • Drug: Upadacitinib
  • Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 28, 2022): 68
• Original Estimated Enrollment (submitted: June 11, 2020): 60
• Actual Study Completion Date: January 25, 2022
• Actual Primary Completion Date: April 22, 2021 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada, Japan, Puerto Rico, United States

Administrative Information

• NCT Number: NCT04430855
• Other Study ID Numbers: M20-040
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
• Supporting Materials: Study Protocol
• Supporting Materials: Statistical Analysis Plan (SAP)
• Supporting Materials: Clinical Study Report (CSR)
• Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
• URL: https://vivli.org/ourmember/abbvie/

• Current Responsible Party: AbbVie
• Original Responsible Party: Same as current
• Current Study Sponsor: AbbVie
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: ABBVIE INC.; AbbVie

• PRS Account: AbbVie
• Verification Date: January 2023