Hidradenitis Suppurativa (HS)Phase 2NCT04430855
A Study of Oral Upadacitinib Tablet Compared to Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa to Assess Change in Disease Symptoms
A Phase 2 study testing Upadacitinib in people with Hidradenitis Suppurativa (HS), run by AbbVie at 26 sites in 4 countries.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hidradenitis Suppurativa (HS)
- What is being tested?
- Upadacitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 26 sitesin 4 countries
- Study dates
- 14 Jul 2020to 25 Jan 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- -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.
Trial locations and contacts
26 sites in 4 countries.
26 sites in 4 countries
United States18 sites
Skin Care Research - Boca Raton /ID# 218809
Boca Raton, Florida, 33486-2269
Beth Israel Deaconess Medical Center /ID# 218306
Boston, Massachusetts, 02215-5400
Medical University of South Carolina /ID# 218318
Charleston, South Carolina, 29425
University Hospitals Case Medical Center /ID# 218326
Cleveland, Ohio, 44106
Duke Cancer Center /ID# 218526
Durham, North Carolina, 27710-3000
Psoriasis Treatment Center of Central New Jersey /ID# 218330
East Windsor, New Jersey, 08520
Duplicate_Center for Clinical Studies /ID# 218307
Houston, Texas, 77004
Dawes Fretzin, LLC /ID# 218310
Indianapolis, Indiana, 46256
University of Arkansas for Medical Sciences /ID# 218404
Little Rock, Arkansas, 72205
Lakes Research, LLC /ID# 218854
Miami, Florida, 33014
Medical Dermatology Specialist /ID# 221084
Phoenix, Arizona, 85006-2722
University of Pittsburgh MC /ID# 218329
Pittsburgh, Pennsylvania, 15260
Medderm Associates /ID# 218317
San Diego, California, 92103
Northshore University Health System Dermatology Clinical Trials Unit /ID# 218319
Skokie, Illinois, 60077
Dermatology Specialists of Spokane /ID# 218760
Spokane, Washington, 99202
Washington University-School of Medicine /ID# 218331
St Louis, Missouri, 63110
ForCare Clinical Research /ID# 218013
Tampa, Florida, 33613-1244
Southside Dermatology /ID# 218321
Tulsa, Oklahoma, 74132
Canada4 sites
Dermatology Research Institute Inc. /ID# 218780
Calgary, Alberta, T2J 7E1
Dr. Wei Jing Loo Medicine Prof /ID# 218779
London, Ontario, N6H 5L5
Lynderm Research Inc. /ID# 218778
Markham, Ontario, L3P 1X2
Winnipeg Clinic /ID# 218963
Winnipeg, Manitoba, R3C 0N2
Japan3 sites
University Hospital Kyoto Prefectural University of Medicine /ID# 220859
Kyoto, Kyoto, 602-8566
Toranomon Hospital /ID# 218588
Minato-ku, Tokyo, 105-8470
Takagi Dermatology Clinic /ID# 218587
Obihiro-shi, Hokkaido, 080-0013
About this study
Official title: A Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Upadacitinib in Adult Subjects With Moderate to Severe Hidradenitis Suppurativa
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.
Read the 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.
- Conditions
- Hidradenitis Suppurativa (HS)
- Being tested
- Upadacitinib, Placebo
- Keywords
- Hidradenitis suppurativa (HS), Upadacitinib
- Medical subject headings
- Hidradenitis Suppurativa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UpadacitinibDrug
Also called RINVOQ
Tablet; Oral
PlaceboDrug
Tablet; Oral
| Study group | Role | What they receive |
|---|---|---|
| Upadacitinib 30 mg | Experimental | 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). Receives: Drug: Upadacitinib |
| Placebo followed by Upadacitinib 15 mg | Experimental | 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). Receives: Drug: Upadacitinib; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at 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.
Measured: Baseline and Week 12
Secondary outcomes (1)
Percentage of Participants Achieving PGA Skin Pain Numeric Rating Scale 30 (NRS30) Response at Week 12 Among Participants With Baseline NRS ≥ 3
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.
Measured: Baseline and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2020
- Study start14 Jul 2020
- Primary completion22 Apr 2021
- Study completion25 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hidradenitis Suppurativa (HS)Studies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04430855
- Sponsor's protocol ID
- M20-040
- Status last verified
- Jan 2023
- First submitted
- 11 Jun 2020
- Last updated
- 6 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Ackerman LS, Schlosser BJ, Zhan T, Prajapati VH, Fretzin S, Takahashi H, Huang X, Camp HS, Kimball AB. Improvements in moderate-to-severe hidradenitis suppurativa with upadacitinib: Results from a phase 2, randomized, placebo-controlled study. J Am Acad Dermatol. 2025 Jun;92(6):1252-1260. doi: 10.1016/j.jaad.2024.12.046. Epub 2025 Feb 4.
PubMed 39909350
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Upadacitinib in Adult Subjects With Moderate to Severe Hidradenitis Suppurativa
- ClinicalTrials.gov ID
- NCT04430855
- Acronym / sponsor ID
- M20-040
- Conditions
- Hidradenitis Suppurativa (HS)
- Keywords
- Hidradenitis suppurativa (HS), Upadacitinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 14 Jul 2020 (actual)
- Primary completion
- 22 Apr 2021 (actual)
- Study completion
- 25 Jan 2022 (actual)
- First posted
- 12 Jun 2020 (actual)
- Results
- Posted 6 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Upadacitinib 30 mg | Experimental | Drug: UpadacitinibParticipants 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). |
| Placebo followed by Upadacitinib 15 mg | Experimental | Drug: Upadacitinib, Drug: PlaceboParticipants 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- -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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UpadacitinibAlso: RINVOQTablet; Oral | Drug | Placebo followed by Upadacitinib 15 mg, Upadacitinib 30 mg |
| PlaceboTablet; Oral | Drug | Placebo followed by Upadacitinib 15 mg |
Primary outcome
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.
1 secondary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39909350Ackerman LS, Schlosser BJ, Zhan T, Prajapati VH, Fretzin S, Takahashi H, Huang X, Camp HS, Kimball AB. Improvements in moderate-to-severe hidradenitis suppurativa with upadacitinib: Results from a phase 2, randomized, placebo-controlled study. J Am Acad Dermatol. 2025 Jun;92(6):1252-1260. doi: 10.1016/j.jaad.2024.12.046. Epub 2025 Feb 4.
- This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ABBVIE INC. study director
AbbVie
26 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Upadacitinib in people with Hidradenitis Suppurativa (HS), run by AbbVie at 26 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in United States, Canada, Japan, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12 (time frame: Baseline and Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04430855, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2023.