Hidradenitis SuppurativaPhase 2NCT06956235
Study to Evaluate Tulisokibart for Hidradenitis Suppurativa (MK-7240-012)
A Phase 2 study testing Tulisokibart in people with Hidradenitis Suppurativa, run by Merck Sharp & Dohme LLC at 68 sites in 15 countries.
Trial summary
This is a phase 2b randomized, double-blind, placebo-controlled study of the safety and efficacy of tulisokibart in participants with moderate to severe hidradenitis suppurativa. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hidradenitis Suppurativa
- What is being tested?
- Tulisokibart
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 149 participants
- Where
- 68 sitesin 15 countries
- Study dates
- 9 Jun 2025to 6 Jun 2028
- Phase
- Phase 2
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has signs and symptoms of hidradenitis suppurativa (HS) for ≥6 months prior to Screening and a clinical diagnosis of HS at Screening
- Has moderate or severe HS defined as a total combined number of ≥ 5 abscesses and/or inflammatory nodules, with HS lesions present in ≥ 2 distinct anatomical areas and ≥ 1 anatomic area of HS involvement characterized as Hurley Stage II or III
- Has a history of inadequate response to a course of systemic antibiotics for treatment of HS or intolerance to or has a contraindication to systemic antibiotics for treatment of HS
- Has ≤20 draining tunnel count at Screening and Randomization
Who cannot join
- Has other active skin conditions that may, in the judgment of the investigator, interfere with the assessment of HS
- Has any immune-mediated inflammatory condition that is not well controlled and which may potentially require biologic therapy
- Has a transplanted organ and requires continued systemic immunosuppression
- Has a history of cancer (except fully treated nonmelanoma skin cancers or cervical carcinoma in situ after complete surgical removal) and is disease free for <5 years
- Has had a diagnostic evaluation suggestive of malignancy (eg, chest or breast imaging) and the possibility of malignancy cannot be reasonably excluded following additional clinical assessments
- Has a known infection with hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV)
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- Has any active infection
- Has active tuberculosis
- Has had major surgery within the past 3 months or has a major surgery planned during the study
- Has a history of clinically significant drug or alcohol abuse within the past 6 months
- Has prior exposure to tulisokibart
- Has undergone laser therapy or surgical procedures for their lesions within the past 6 weeks or is planning to have laser therapy or surgical procedures for lesions during participation in the study
- Has known allergies, hypersensitivity, or intolerance to tulisokibart or its excipients
Trial locations and contacts
68 sites in 15 countries.
68 sites in 15 countries
United States19 sites
Palmetto Clinical Trial Services, LLC ( Site 0023)
Anderson, South Carolina, 29621
Arlington Center for Dermatology ( Site 0045)
Arlington, Texas, 76011
Cahaba Dermatology & Skin Health Center ( Site 0012)
Birmingham, Alabama, 35244
Beth Israel Deaconess Medical Center ( Site 0044)
Boston, Massachusetts, 02215
DJL Clinical Research, PLLC ( Site 0021)
Charlotte, North Carolina, 28211
University Hospitals Cleveland Medical Center ( Site 0046)
Cleveland, Ohio, 44106
Texas Dermatology Research Center ( Site 0019)
Dallas, Texas, 75246
Wright State Physicians Health Center ( Site 0041)
Fairborn, Ohio, 45324
Reveal Research Institute ( Site 0018)
Frisco, Texas, 75033
Dawes Fretzin Clinical Research Group, LLC ( Site 0025)
Indianapolis, Indiana, 46250
Skin Care Physicians of Georgia ( Site 0033)
Macon, Georgia, 31217
Mount Sinai Doctors - East 85th Street ( Site 0050)
New York, New York, 10028
Northridge Clinical Trials ( Site 0004)
Northridge, California, 91325
Medical Dermatology Specialists ( Site 0027)
Phoenix, Arizona, 85006
Northwest Arkansas Clinical Trials Center, PLLC ( Site 0049)
Rogers, Arkansas, 72758
Integrative Skin Science and Research ( Site 0015)
Sacramento, California, 95815
Progressive Clinical Research ( Site 0020)
San Antonio, Texas, 78213
Olympian Clinical Research ( Site 0010)
Tampa, Florida, 33615
Revival Research Institute, LLC ( Site 0005)
Troy, Michigan, 48084
China7 sites
The First Hospital of Jilin University ( Site 1502)
Changchun, Jilin, 130021
The Second Xiangya Hospital of Central South University ( Site 1505)
Changsha, Hunan, 410011
Dermatology Hospital of Southern Medical University ( Site 1504)
Guangzhou, Guangdong, 516006
The first Affiliated Hospital, Zhejiang University School of Medicine ( Site 1501)
Hangzhou, Zhejiang, 310003
Ruijin Hospital Shanghai Jiaotong University School of Medicine ( Site 1515)
Shanghai, Shanghai Municipality, 200025
Huashan Hospital of Fudan University ( Site 1506)
Shanghai, Shanghai Municipality, 200040
PEOPLE'S HOSPITAL OF XINJIANG UYGUR AUTONOMOUS REGION ( Site 1509)
Ürümqi, Xinjiang, 830001
Japan6 sites
Fukuoka University Hospital ( Site 1604)
Fukuoka, 814-0180
University of the Ryukyus Hospital ( Site 1601)
Ginowan, Okinawa, 901-2725
University Hospital,Kyoto Prefectural University of Medicine ( Site 1605)
Kyoto, 602-8566
Nagoya City University Hospital ( Site 1603)
Nagoya, Aichi-ken, 467-8602
Medical Corporation Kojinkai Sapporo Skin Clinic ( Site 1606)
Sapporo, Hokkaido, 060-0063
Nihon University Itabashi Hospital ( Site 1602)
tabashi City, Tokyo, 173-8610
Canada5 sites
Brunswick Dermatology Center ( Site 0101)
Frederiction, New Brunswick, E3B 1G9
Lynderm Research Inc. ( Site 0104)
Markham, Ontario, L3P 1X3
SKiN Centre for Dermatology ( Site 0103)
Peterborough, Ontario, K9J 5K2
York Dermatology Clinic & Research Centre ( Site 0106)
Richmond Hill, Ontario, L4B 1L1
Wiseman Dermatology Research Inc. ( Site 0107)
Winnipeg, Manitoba, R3M 3Z4
Argentina4 sites
CIPREC ( Site 0202)
CABA, C1061AAT
Hospital Italiano de Buenos Aires ( Site 0205)
CABA, C1199ABB
Psoriahue ( Site 0203)
CABA, C1425DKG
Derma Internacional SA ( Site 0206)
CABA, C1426EGR
France4 sites
CHU de Bordeaux Hop St ANDRE ( Site 0603)
Bordeaux, Gironde, 33075
Hôpital Edouard Herriot ( Site 0601)
Lyon, Auvergne-Rhône-Alpes, 69003
Hopitaux Universitaires Paris Centre-Hopital Cochin ( Site 0602)
Paris, 75679
HIA Sainte Anne ( Site 0606)
Toulon, Var, 83800 Cede
Spain4 sites
Hospital Universitari Vall d'Hebron ( Site 1102)
Barcelona, 08035
Hospital Universitari de Bellvitge ( Site 1101)
Barcelona, 08907
Hospital Universitario Virgen Nieves ( Site 1104)
Granada, 18012
Hospital de Manises ( Site 1103)
Manises, Valencia, 46940
Australia3 sites
Fremantle Dermatology ( Site 1402)
Fremantle, Western Australia, 6160
Liverpool Hospital ( Site 1403)
Liverpool, New South Wales, 1871
The Alfred Hospital ( Site 1401)
Melbourne, Victoria, 3004
Chile3 sites
Centro Skin Med Limitada ( Site 0305)
Santiago, Region M. de Santiago, 7580206
Clinica Dermacross ( Site 0301)
Santiago, Region M. de Santiago, 7640881
Centro Internacional de Estudios Clinicos (CIEC) ( Site 0302)
Santiago, Region M. de Santiago, 8420383
Italy3 sites
AOU Ospedali Riuniti di Ancona ( Site 1805)
Ancona, The Marches, 60126
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico ( Site 1806)
Milan, 20122
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 1801)
Roma, 00168
Colombia2 sites
Fundación Valle del Lili ( Site 0403)
Cali, Valle del Cauca Department, 760032
Servicios de Salud IPS Suramericana S.A.S. - IPS Sura San Diego ( Site 0404)
Medellín, Antioquia, 050021
Germany2 sites
Charite - Universtitatsmedizin Berlin CCM ( Site 0708)
Berlin, 10117
Frankfurt Universitaetsklinikum EC ( Site 0706)
Frankfurt am Main, Hesse, 60590
Netherlands2 sites
Amphia Ziekenhuis, locatie Breda Molengracht ( Site 0902)
Breda, North Brabant, 4818 CK
Erasmus Medisch Centrum ( Site 0901)
Rotterdam, South Holland, 3015 GD
Singapore2 sites
National Universtity Hospital IMU ( Site 0802)
Singapore, Central Singapore, 117599
National Skin Centre ( Site 0801)
Singapore, Central Singapore, 308205
United Kingdom2 sites
Russells Hall Hospital ( Site 1303)
Dudley, England, DY1 2HQ
Royal London Hospital ( Site 1301)
London, England, E1 1BB
About this study
Official title: A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tulisokibart in Participants With Moderate to Severe Hidradenitis Suppurativa
This is a phase 2b randomized, double-blind, placebo-controlled study of the safety and efficacy of tulisokibart in participants with moderate to severe hidradenitis suppurativa. The primary hypothesis is that at least 1 dose of tulisokibart is superior to placebo with respect to the proportion of participants achieving a 50% reduction in Hidradenitis Suppurativa Clinical Response (HiSCR50) at Week 16 (ie, at end of double-blind treatment).
Read the detailed description
This study consists of a 16-week Double-blind Period and a 100-week Long-term Extension (LTE) composed of a 40-week Main Extension and a 60-week Optional Extension.
- Conditions
- Hidradenitis Suppurativa
- Being tested
- Tulisokibart, Placebo
- Medical subject headings
- Hidradenitis Suppurativa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TulisokibartDrug
Also called PRA023, MK-7240
Solution in autoinjector for subcutaneous (SC) injection
PlaceboDrug
Solution in autoinjector for SC injection
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: High Dose | Experimental | Participants receive a high dose tulisokibart regimen. Receives: Drug: Tulisokibart |
| Arm 2: Medium Dose | Experimental | Participants receive a medium dose tulisokibart regimen. Receives: Drug: Tulisokibart |
| Arm 3: Low Dose | Experimental | Participants receive a low dose tulisokibart regimen. Receives: Drug: Tulisokibart |
| Arm 4: Placebo | Placebo comparator | Participants receive a placebo regimen, and are then allocated to a medium or high tulisokibart dose regimen after Week 16. Receives: 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) 50 at Week 16
The percentage of participants with ≥50% reduction in total abscesses and inflammatory nodules (AN) count with no increase in abscess count, and no increase in draining tunnels (ie, HiSCR50) will be reported.
Measured: Week 16
Secondary outcomes (4)
Percentage of Participants Achieving HiSCR75 at Week 16
The percentage of participants with ≥75% reduction in total abscesses and inflammatory nodules (AN) count with no increase in abscess count, and no increase in draining tunnels (ie, HiSCR75) will be reported.
Measured: Week 16
Mean Change from Baseline in Dermatology Life Quality Index (DLQI) at Week 16
The DLQI is a validated dermatology-specific instrument that measures the HRQoL in adult patients with skin diseases. The DLQI consists of 10 questions and provides a total HRQoL score, as well as scores for 6 aspects of QoL: symptoms and feelings; daily activities; leisure; work/school; personal relationships; and treatment. The recall period is over the last week. Question responses are assessed using a 4-point Likert rating scale ranging from "not at all" (scored 0) to "very much" (scored 3). The final score ranges from 0 (no impact on QOL) to 30 (maximum impairment). The mean change from baseline in DLQI at Week 16 will be reported.
Measured: Week 16
Percentage of Participants Who Experience One or More Adverse Events (AEs)
An AE is defined as any untoward medical occurrence in a participant administered a study treatment which did not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of study treatment, is also an AE. The percentage of participants with any AE will be reported.
Measured: Up to ~130 weeks
Percentage of Participants Who Discontinue Study Intervention Due to an AE
An AE is defined as any untoward medical occurrence in a participant administered a study treatment which did not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of study treatment, is also an AE. The percentage of participants discontinuing from study intervention due to AE will be reported.
Measured: Up to ~116 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2025
- Study start9 Jun 2025
- Primary completion2 Apr 2026
- Study completion6 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hidradenitis SuppurativaStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06956235
- Sponsor's protocol ID
- 7240-012
- Other IDs
- U1111-1316-5263, 2024-520039-33-00, jRCT2011250007, MK-7240-012
- Status last verified
- Oct 2026
- First submitted
- 30 Apr 2025
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf