Tulisokibart for Hidradenitis Suppurativa

Recruiting at 67 trial locations

Overseen By Toll Free Number

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Merck Sharp & Dohme LLC

Must not be taking: Biologics, Immunosuppressants

Disqualifiers: Active skin conditions, Cancer, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

147 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of a new treatment, tulisokibart, for individuals with moderate to severe hidradenitis suppurativa, a chronic skin condition causing painful bumps and abscesses. Researchers aim to determine if tulisokibart can reduce symptoms by at least 50% after 16 weeks compared to a placebo (a non-active treatment). Participants will initially receive a high, medium, or low dose of tulisokibart, or a placebo, before switching to a medium or high dose later. This trial may suit those who have had hidradenitis suppurativa for at least six months, experience it in multiple body areas, and have not responded well to antibiotics. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is there any evidence suggesting that tulisokibart is likely to be safe for humans?

Research shows that tulisokibart is being tested for safety in humans. In earlier studies, participants tolerated the treatment well at various doses. Some side effects occurred, but they were mostly mild, such as headaches or slight skin irritation.

Tulisokibart is now in phase 2b trials, indicating it has already passed initial safety tests. This phase focuses on finding the right dose, so serious side effects are usually rare at this stage. This suggests the treatment is generally safe, but ongoing trials will provide more detailed information.

While tulisokibart is being tested for hidradenitis suppurativa, it is also under study for other conditions. This broader testing helps ensure its safety across different groups of people. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for hidradenitis suppurativa?

Researchers are excited about Tulisokibart for Hidradenitis Suppurativa because it offers a fresh approach compared to existing treatments like antibiotics and biologics. Unlike these standard options, Tulisokibart works by specifically targeting inflammatory pathways that are believed to play a key role in this condition. This targeted action could potentially lead to more effective management of symptoms with fewer side effects. Additionally, the trial explores different dosing regimens, which might offer flexibility in treatment options for patients. Overall, Tulisokibart has the potential to provide a more precise and tailored treatment experience for individuals suffering from Hidradenitis Suppurativa.

What evidence suggests that tulisokibart might be an effective treatment for hidradenitis suppurativa?

Research has shown that tulisokibart could help treat hidradenitis suppurativa, a skin condition that causes painful lumps. Studies suggest that tulisokibart may reduce swelling and redness and lower the number of painful bumps. The treatment aims to cut these symptoms by at least half without causing new lumps to form. Early results indicated that some doses of tulisokibart worked better than a placebo in achieving this goal. This trial will evaluate different doses of tulisokibart, making it a promising option for managing moderate to severe hidradenitis suppurativa. ^{2 3 4 5 6}

Who Is on the Research Team?

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Are You a Good Fit for This Trial?

This trial is for individuals with moderate to severe hidradenitis suppurativa (HS), a skin condition, who haven't responded well to antibiotics or can't take them. Participants should have had HS symptoms for at least 6 months and no more than 20 draining tunnels at the time of screening.

Inclusion Criteria

Has moderate or severe HS

I've had a poor response or can't take antibiotics for my skin condition.

I have had symptoms of HS for 6 months or more and have been diagnosed with HS.

Exclusion Criteria

Has other active skin conditions that may interfere with the assessment of HS

Has known allergies, hypersensitivity, or intolerance to tulisokibart or its excipients

I have an immune condition that might need biologic therapy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Double-blind Treatment

Participants receive either a high, medium, or low dose of tulisokibart or placebo for 16 weeks

16 weeks

Main Extension

Participants continue treatment in a 40-week main extension period

40 weeks

Optional Extension

Participants may opt into a 60-week optional extension for long-term treatment

60 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Tulisokibart

Trial Overview The study tests Tulisokibart against a placebo in people with HS. It's randomized and double-blind, meaning neither participants nor researchers know who gets the real drug. The goal is to see if Tulisokibart helps reduce HS symptoms by at least half after 16 weeks.

How Is the Trial Designed?

Group I: Arm 3: Low Dose Experimental Treatment 1 Intervention

Participants receive a low dose tulisokibart regimen.

Group II: Arm 2: Medium Dose Experimental Treatment 1 Intervention

Participants receive a medium dose tulisokibart regimen.

Group III: Arm 1: High Dose Experimental Treatment 1 Intervention

Participants receive a high dose tulisokibart regimen.

Group IV: Arm 4: Placebo Placebo Group 1 Intervention

Participants receive a placebo regimen, and are then allocated to a medium or high tulisokibart dose regimen after Week 16.

Who Is Running the Clinical Trial?

Merck Sharp & Dohme LLC

Lead Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06956235

Study to Evaluate Tulisokibart for 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 ...

2. merckclinicaltrials.com merckclinicaltrials.com/trial/nct06956235/

Study to Evaluate Tulisokibart for Hidradenitis Suppurativa Tulisokibart is being tested to see if it may help control the inflammationInflammationRedness, swelling, pain, and increased warmth or heat in the area (a ...

3. merck.com merck.com/news/merck-expands-tulisokibart-clinical-development-program-with-initiation-of-phase-2b-trials-in-three-additional-immune-mediated-inflammatory-diseases/

Merck Expands Tulisokibart Clinical Development Program ... Hidradenitis suppurativa affects a variable proportion of the population, with prevalence estimates ranging from 0.1% to 0.8%.

4. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/604955

Study to Evaluate Tulisokibart for Hidradenitis Suppurativa ... 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 ...

5. trialx.com trialx.com/clinical-trials/listings/299161/study-to-evaluate-tulisokibart-for-hidradenitis-suppurativa-mk-7240-012/?&radius=11000

Study to Evaluate Tulisokibart for Hidradenitis Suppurativa ... This is a phase 2b randomized, double-blind, placebo-controlled study of the safety and efficacy of tulisokibart in participants with moderate ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06956235

Study to Evaluate Tulisokibart for 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 ...