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. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT04430855 |
|
Recruitment Status :
Completed
First Posted : June 12, 2020
Last Update Posted : March 24, 2022
|
- Study Details
- Tabular View
- Results Submitted
- Disclaimer
- How to Read a Study Record
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) |
| Actual Enrollment : | 68 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 |
| Actual Primary Completion Date : | April 22, 2021 |
| Actual Study Completion Date : | January 25, 2022 |
| 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 Upadcitinib Dose B for 36 weeks (Period 2).
|
Drug: Upadacitinib
Tablet; Oral
Other Name: RINVOQ Drug: Placebo Upadacitinib Tablet; Oral |
- 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.
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.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
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
Show 26 study locations
| Study Director: | ABBVIE INC. | AbbVie |
| Responsible Party: | AbbVie |
| ClinicalTrials.gov Identifier: | NCT04430855 |
| Other Study ID Numbers: |
M20-040 |
| First Posted: | June 12, 2020 Key Record Dates |
| Last Update Posted: | March 24, 2022 |
| Last Verified: | March 2022 |
| 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 |
| 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 |
|
Hidradenitis suppurativa (HS) Upadacitinib |
|
Hidradenitis Suppurativa Hidradenitis Sweat Gland Diseases Skin Diseases Skin Diseases, Bacterial Bacterial Infections Bacterial Infections and Mycoses Infections |
Skin Diseases, Infectious Suppuration Upadacitinib Janus Kinase Inhibitors Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antirheumatic Agents |