A clinical study of tulisokibart in people with hidradenitis suppurativa (MK-7240-012)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Merck Sharp & Dohme LLC

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17]

Trial duration

11 Aug 2025 → ongoing

Decision date (initial)

2025-08-04

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Merck Sharp & Dohme LLC

External identifiers

EU CT number

2024-520039-33-00

WHO UTN

U1111-1316-5263

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacogenetic, Pharmacodynamic, Pharmacogenomic, Safety, Therapy, Efficacy, Pharmacokinetic

1. To evaluate the efficacy of tulisokibart compared with placebo as assessed by the proportion of participants achieving HiSCR50 at Week 16

Secondary objectives 3

1. To evaluate the efficacy of tulisokibart compared with placebo as assessed by the proportion of participants achieving HiSCR75 at Week 16
2. To evaluate the efficacy of tulisokibart compared with placebo as assessed by mean change from baseline in the DLQI at Week 16
3. To evaluate the safety and tolerability of tulisokibart

Conditions and MedDRA coding

Hidradenitis Suppurativa

Regulatory references

Plan to share IPD

Yes

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Has signs and symptoms of hidradenitis suppurativa (HS) for ≥ 6 months prior to Screening and a clinical diagnosis of HS at Screening
2. 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
3. Has a history of inadequate response to a course of systemic antibiotics for treatment of HS or intolerance to systemic antibiotics for treatment of HS
4. Has ≤20 draining tunnel count at Screening and Randomization

Exclusion criteria 13

1. Has other active skin conditions that may, in the judgment of the investigator, interfere with the assessment of HS
2. Has any immune-mediated inflammatory condition that is not well controlled and which may potentially require biologic therapy
3. Has a transplanted organ and requires continued systemic immunosuppression
4. 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
5. 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
6. Has a known infection with hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV)
7. Has any active infection
8. Has active tuberculosis
9. Has had major surgery within the past 3 months or has a major surgery planned during the study
10. Has a history of clinically significant drug or alcohol abuse within the past 6 months
11. Has prior exposure to tulisokibart
12. 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
13. Has known allergies, hypersensitivity, or intolerance to tulisokibart or its excipients

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR)50 at Week 16

Secondary endpoints 4

1. Percentage of Participants Achieving HiSCR75 at Week 16
2. Mean Change from Baseline in Dermatology Life Quality Index (DLQI) at Week 16
3. Percentage of Participants Who Experience One or More Adverse Events (AEs)
4. Percentage of Participants Who Discontinue Study Intervention Due to an AE

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Merck Sharp & Dohme LLC

Sponsor organisation

Merck Sharp & Dohme LLC

Address

126 East Lincoln Avenue, P. O. Box 2000 P. O. Box 2000

City

Rahway

Postcode

07065-4607

Country

United States

Scientific contact point

Organisation

Merck Sharp & Dohme LLC

Contact name

Aileen Dualan

Public contact point

Organisation

Merck Sharp & Dohme LLC

Contact name

Aileen Dualan

Third parties 12

Locations

5 EU/EEA countries · 13 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 61 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

5 submissions — initial application plus substantial / non-substantial modifications