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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04430855
Recruitment Status : Recruiting
First Posted : June 12, 2020
Last Update Posted : November 6, 2020
Sponsor:
Information provided by (Responsible Party):
AbbVie

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 (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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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).
Drug: Upadacitinib
Tablet; Oral
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).
Drug: Upadacitinib
Tablet; Oral
Other Name: RINVOQ

Drug: Placebo Upadacitinib
Tablet; Oral




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Contacts
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Contact: ABBVIE CALL CENTER 847.283.8955 abbvieclinicaltrials@abbvie.com

Locations
Show Show 28 study locations
Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie
Additional Information:
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT04430855    
Other Study ID Numbers: M20-040
First Posted: June 12, 2020    Key Record Dates
Last Update Posted: November 6, 2020
Last Verified: November 2020
Individual Participant Data (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 and 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
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
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 (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
URL: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html

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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
Keywords provided by AbbVie:
Hidradenitis suppurativa (HS)
Upadacitinib
Additional relevant MeSH terms:
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Hidradenitis Suppurativa
Hidradenitis
Sweat Gland Diseases
Skin Diseases
Skin Diseases, Bacterial
Bacterial Infections
Skin Diseases, Infectious
Infection
Suppuration
Upadacitinib
Janus Kinase Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents