Efficacy and Safety Evaluation of Tulisokibart in Moderate to Severe Hidradenitis Suppurativa: A Phase 2b Randomized, Double-Blind, Placebo-Controlled Trial
- Trial ID
- 2024-520039-33-00
- Protocol
- MK-7240-012
- Sponsor
- Merck Sharp & Dohme LLC
Trial statistics
Diseases & Conditions
Objectives
There is no available information regarding the primary or secondary objectives of the study, nor is there any data on the medical condition being investigated. Consequently, a detailed description of the study's objectives cannot be provided.
Participants
The sponsor does not provide information regarding the **participants** of the clinical trial, including the total number of participants, age range, gender, general health status, or any relevant lifestyle considerations. Additionally, details about the selection process for the trial population, as well as key inclusion or exclusion criteria, are not disclosed. Consequently, no specific data about the study population or their characteristics is available for this trial.
Plans and Procedures
The clinical trial is designed as a **randomized**, **double-blind**, and **controlled** study to ensure the reliability and validity of the results. The trial will be conducted over a specified duration, with participants expected to be involved for the entirety of the study period unless early termination criteria are met. The sequence of study visits is structured to include an initial **screening** visit, multiple follow-up visits, and a final end-of-study visit. The screening visit is intended to assess eligibility based on predefined inclusion and exclusion criteria. Follow-up visits are scheduled at regular intervals to monitor the participants' health status, adherence to the study protocol, and any adverse events. The end-of-study visit will involve a comprehensive evaluation to gather final data and ensure participant safety. Participants may be withdrawn from the study if they experience significant adverse effects, fail to comply with the study protocol, or choose to withdraw consent. The trial's methodology is meticulously planned to maintain scientific rigor and ethical standards throughout the study duration.
Treatment
No specific information regarding the experimental medication, including its name, pharmaceutical form, dosage, route, and frequency of administration, is provided in the available data. Consequently, a detailed description of the experimental treatment cannot be formulated based on the current dataset.
Similarly, there is no information available about any non-experimental treatments, such as standard-of-care therapy, placebo, or comparator treatment, used in the study. Therefore, a description of these elements is not possible with the given data.
Additional relevant information about drug administration, dosing schedules, and participant compliance monitoring is also absent from the provided data. As such, no further details can be included in this description.
Efficacy
No information is available to provide a description of how efficacy will be assessed in the clinical trial. Details regarding parameters or endpoints, methods, schedule for measuring, collecting, and analyzing efficacy parameters, as well as tools or instruments involved in efficacy assessments, are not provided.
Inclusion and Exclusion Criteria
Inclusion Criteria
- 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 systemic antibiotics for treatment of HS
- Has ≤20 draining tunnel count at Screening and Randomization
Exclusion Criteria
- 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)
- 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 Status by Country
| Country | Status | Start of Recruitment | Planned Patients |
|---|---|---|---|
France | Not Recruiting | 17 Jun 2025 | 12 |
Germany | Not Recruiting | 17 Jun 2025 | 12 |
Italy | Not Recruiting | 17 Jun 2025 | 10 |
The Netherlands | Not Recruiting | 17 Jun 2025 | — |
Spain | Not Recruiting | 17 Jun 2025 | 8 |
Netherlands | — | — | 4 |
Sites & Investigators
Investigational Products
Details about the medicinal products being studied in this clinical trial.
| Product Name | Role in Trial | Formulation | Administration | Max Daily Dose | Treatment Duration | EU MP Number |
|---|---|---|---|---|---|---|
Placebo for MK-7240 | Placebo | N/A | — | — | — | N/A |
tulisokibart | Test | SOLUTION FOR INJECTION IN PRE-FILLED INJECTOR | SUBCUTANEOUS USE | 0 | 116 | PRD10740873 |





