Zasocitinib for Hidradenitis Suppurativa

Not yet recruiting at 48 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Takeda

Must not be taking: Rifampin

Disqualifiers: Tuberculosis, Hepatitis, HIV, others

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

Compensation: Varies

Number of Visits: 12

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called zasocitinib to determine its safety and effectiveness for people with hidradenitis suppurativa (HS), a skin condition that causes painful bumps and abscesses. Participants will receive either zasocitinib or a placebo (a pill with no active medicine) for the first 4 months, followed by zasocitinib for another 8 months. The trial seeks adults who have had HS for at least 6 months and have experienced inadequate results from previous antibiotic treatments. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to the development of a potentially effective therapy.

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

Research has shown that JAK inhibitors, such as zasocitinib, are promising and generally safe for treating Hidradenitis Suppurativa (HS). Studies have found that most patients tolerate these treatments well. Although some side effects, like headaches or mild stomach issues, have been reported, they are usually mild. Serious side effects are rare. Participants should discuss any concerns with their study team to understand how this treatment might work for them. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Hidradenitis Suppurativa?

Zasocitinib is unique because it targets the specific pathways involved in inflammation and immune response, which are critical in hidradenitis suppurativa. Unlike current treatments like antibiotics and TNF inhibitors, Zasocitinib is a Janus kinase (JAK) inhibitor, meaning it blocks the activity of specific enzymes that contribute to the symptoms of this condition. This targeted approach not only promises to reduce inflammation more effectively but also aims to improve symptoms more quickly. Researchers are excited about Zasocitinib because it offers a novel mechanism of action that could lead to better outcomes for patients who struggle with the limitations of existing treatments.

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

Research has shown that zasocitinib may help treat skin conditions like hidradenitis suppurativa. In earlier studies, patients experienced significant improvements in their quality of life as soon as four weeks after starting treatment, with these improvements lasting up to 12 weeks. From week 8, more patients saw a significant decrease in the affected skin area compared to those who took a placebo. This evidence suggests that zasocitinib could effectively reduce the painful symptoms of hidradenitis suppurativa. During the trial, participants will receive either zasocitinib or a placebo in the double-blind period, followed by an open-label period where all participants will receive zasocitinib. ^{6 7 8 9 10}

Who Is on the Research Team?

Study Director

Principal Investigator

Takeda

Are You a Good Fit for This Trial?

This trial is for adults with Hidradenitis Suppurativa, a painful skin condition with swollen bumps and abscesses. Participants will be treated for up to 4 months, followed by an extension where all receive the study drug. Key eligibility includes not having certain health conditions that could interfere with the trial.

Inclusion Criteria

I meet the trial's birth control requirements.

I have HS lesions in 2 different areas, one is at least moderate to severe.

Participants must have a total of greater than or equal to (>=) 5 inflammatory lesions (that is, number of abscesses plus number of inflammatory nodules) at both screening and Day 1

Exclusion Criteria

I show signs of active tuberculosis as determined by a doctor.

I have tested positive for hepatitis B or have indicators of a past or current infection.

I have a history of chronic or recurrent infections.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment (Double-blind)

Participants receive either zasocitinib or placebo for up to 4 months

16 weeks

12 visits (in-person)

Treatment (Open-label)

All participants receive zasocitinib for up to 8 months

36 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Zasocitinib

Trial Overview The study tests Zasocitinib's safety and effectiveness against HS compared to a placebo (a capsule without medicine). Initially, participants are randomly assigned to receive either Zasocitinib or placebo for 16 weeks before all transition to Zasocitinib treatment.

How Is the Trial Designed?

Group I: Open-label: Zasocitinib (Dose A) Experimental Treatment 1 Intervention

Participants will receive zasocitinib (Dose A) from Week 16 to Week 52 during the open label period.

Group II: Double-blinded: Zasocitinib (Dose A) Experimental Treatment 1 Intervention

Participants will receive zasocitinib (Dose A) from Day 1 to Week 16 during the double-blind period.

Group III: Double-blinded: Placebo Placebo Group 1 Intervention

Participants will receive placebo from Day 1 to Week 16 during the double-blind period.

Who Is Running the Clinical Trial?

Takeda

Lead Sponsor

Trials

1,255

Recruited

4,219,000+

Dr. Naoyoshi Hirota

Takeda

Chief Medical Officer since 2020

MD from University of Tokyo

Christophe Weber

Takeda

Chief Executive Officer since 2015

PhD in Molecular Biology from Université de Montpellier

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07244263?term=David+Ryan

A Study of Zasocitinib in Adults With Hidradenitis Suppurativa A type of clinical study in which participants are identified as belonging to study groups and are assessed for biomedical or health outcomes.

2. dermnppa.org dermnppa.org/eadv-2025-viewpoints-early-effective-treatment-optimizes-treatment-outcomes/

EADV 2025 Viewpoints: Early, Effective Treatment ... New data at Week 24 show nearly 60% of efficacy-evaluable patients among the povorcitinib 45mg and 75mg treatment groups achieved HiSCR50. Two ...

3. dermatologytimes.com dermatologytimes.com/view/zasocitinib-shows-early-dlqi-gains-in-patients-with-psoriasis

Zasocitinib Shows Early DLQI Gains in Patients with ... At EADV, research showed benefits of zasocitinib on quality of life were observed as early as week 4 and sustained through week 12.

4. trial.medpath.com trial.medpath.com/clinical-trial/2a07a97d9b41da54/nct07244263-zasocitinib-efficacy-safety-moderate-severe-hidradenitis-suppurativa

A Study of Zasocitinib in Adults With Hidradenitis Suppurativa The main aims of this study are to learn how safe zasocitinib is, how well it works and how well adults with HS tolerate it compared with a placebo. The ...

5. skin.dermsquared.com skin.dermsquared.com/skin/article/view/3139?articlesBySameAuthorPage=8

Zasocitinib (TAK-279), a Selective, Oral TYK2 Inhibitor ... From Week 8 onwards, higher proportions of patients achieved a BSA threshold of ≤1% in the zasocitinib 15mg and 30mg groups than in the placebo ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07244263?aggFilters=funderType%3Aindustry%2Cstatus%3Anot%2CstudyType%3Aint&start=2025-01-01_

A Study of Zasocitinib in Adults With Hidradenitis Suppurativa An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10146646/

Hidradenitis Suppurativa and JAK Inhibitors: A Review of ... Results to date in the literature show promising levels of efficacy and the safety of JAK inhibitors in HS. Several clinical trials are underway.

8. trial.medpath.com trial.medpath.com/clinical-trial/2a07a97d9b41da54/

A Study of Zasocitinib in Adults With Hidradenitis Suppurativa The main aims of this study are to learn how safe zasocitinib is, how well it works and how well adults with HS tolerate it compared with a placebo. The ...

9. jaad.org jaad.org/article/S0190-9622(23)03037-2/fulltext

Efficacy and safety of the oral Janus kinase 1 inhibitor ... This placebo-controlled phase 2 study randomized patients with HS 1:1:1:1 to receive povorcitinib 15, 45, or 75 mg or placebo for 16 weeks.

10. practicaldermatology.com practicaldermatology.com/topics/feature/jak-inhibitors-in-hidradenitis-suppurativa-a-systematic-review/29887/

JAK Inhibitors in Hidradenitis Suppurativa: A Systematic ... This review examines the efficacy and safety of JAK inhibitors in HS treatment, exploring their role as a potential transformative therapy for this challenging ...