Zasocitinib for Vitiligo

Recruiting at 69 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Takeda

Must not be taking: Immunosuppressants, Phototherapy

Disqualifiers: Segmental vitiligo, Active TB, Hepatitis, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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

Compensation: Varies

Number of Visits: 11

Duration: 52 weeks

200 Participants Needed

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 individuals with nonsegmental vitiligo, a condition where the immune system attacks skin cells, causing loss of skin color. Participants will receive either zasocitinib or a placebo (a look-alike pill with no medicine) for a year, with some starting on the placebo and switching to zasocitinib after six months. Suitable candidates have nonsegmental vitiligo with patches on both sides of their body. 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 treatment.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop your current medications. However, if you require immunomodulatory or immunosuppressive systemic treatment for an immune-related disease, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that zasocitinib was safe in earlier studies. In one study involving individuals with plaque psoriasis, most experienced only mild side effects, such as headaches or minor stomach issues, while serious side effects were rare. Another study demonstrated stable lab results over 12 weeks, indicating a positive sign for safety.

Zasocitinib is also undergoing testing for other conditions, suggesting it could be a safe treatment option. Although research continues for its use in vitiligo, current data is promising for its safety in humans. Always consult a doctor before deciding to join a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for vitiligo, which often include corticosteroids and topical immunomodulators, Zasocitinib offers a novel approach by targeting specific pathways involved in the autoimmune response. Researchers are excited about Zasocitinib because it works by inhibiting Janus kinase (JAK) pathways, which play a key role in the immune system's attack on skin pigment cells. This targeted mechanism may lead to more effective repigmentation with potentially fewer side effects. Additionally, Zasocitinib is administered orally, providing a convenient alternative to creams and ointments that can be cumbersome for patients. Overall, these features make Zasocitinib a promising candidate in the quest for better vitiligo treatments.

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

Research has shown that Janus kinase inhibitors (JAK inhibitors), such as zasocitinib, can improve vitiligo symptoms. Studies have found that these inhibitors lead to improvements in the Vitiligo Area Scoring Index (VASI), which measures skin repigmentation. For instance, some studies reported up to a 75% improvement in facial vitiligo scores. Additionally, real-world evidence supports the effectiveness and safety of these treatments for vitiligo patients, particularly when used for more than six months. Overall, zasocitinib may help restore skin color in people with vitiligo by targeting the immune response responsible for the loss of skin color.

In this trial, participants will receive different doses of zasocitinib or a placebo followed by zasocitinib to evaluate its effectiveness and safety in treating vitiligo. ^{2 6 7 8 9}

Who Is on the Research Team?

Study Director

Principal Investigator

Takeda

Are You a Good Fit for This Trial?

Adults aged 18-75 with nonsegmental vitiligo, having symmetrical skin depigmentation patches, can join this study. They must agree to birth control measures and be able to follow the trial procedures. People with over 50% hair color loss on face/body or certain infectious/noninfectious diseases, allergies, or abnormal lab results cannot participate.

Inclusion Criteria

Participant meets the birth control requirement as specified

For participants in the EU/EEA or UK, the investigator must have no reason to believe that the participant would be placed at risk by participating in the trial with regard to specific guidelines

Participant has provided written informed consent and any required privacy authorization before the initiation of any trial procedures

Exclusion Criteria

I do not have any recent or current serious infections.

More than half of my hair on my face or body has turned white.

Participant has specific noninfectious disorders as outlined

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either zasocitinib or placebo for up to 1 year, with placebo participants switching to zasocitinib after 6 months

52 weeks

11 visits (in-person)

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 trial is testing Zasocitinib's safety and effectiveness for treating nonsegmental vitiligo compared to a placebo. Participants will take either the actual drug or placebo for up to one year, with those initially on placebo switching to Zasocitinib after six months.

How Is the Trial Designed?

Group I: Zasocitinib Medium Dose Experimental Treatment 1 Intervention

Participants will receive Zasocitinib capsules, medium dose, orally, up to Week 52.

Group II: Zasocitinib Low Dose Experimental Treatment 1 Intervention

Participants will receive Zasocitinib capsules, low dose, orally, up to Week 52.

Group III: Zasocitinib High Dose Experimental Treatment 1 Intervention

Participants will receive Zasocitinib capsules, high dose, orally, up to Week 52.

Group IV: Placebo Group 2/ Zasocitinib High Dose Experimental Treatment 2 Interventions

Participants will receive Placebo Group 2, orally, up to Week 24 followed by Zasocitinib capsules, high dose, orally, up to Week 52.

Group V: Placebo Group 1/ Zasocitinib Medium Dose Experimental Treatment 2 Interventions

Participants will receive Placebo Group 1 orally, up to Week 24 followed by Zasocitinib capsules, medium dose, orally, up to Week 52.

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12126450/

Efficacy and Safety of JAK Inhibitors in the Management of ... Outcomes included a 75% improvement in Facial-Vitiligo Area Scoring Index (F-VASI), mean Vitiligo Area Scoring Index (VASI) improvement, ...

2. jamanetwork.com jamanetwork.com/journals/jamadermatology/fullarticle/2822710

Tyrosine Kinase 2 Inhibition With Zasocitinib in Psoriasis Treatment-emergent adverse events were reported for 53% to 62% of zasocitinib-treated and 44% of placebo-treated patients, with no dose ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0190962225023047

Efficacy and safety of the oral Janus kinase 1 inhibitor ... At week 24, povorcitinib significantly improved T-VASI from baseline (15 mg, 19.1%; 45 mg, 17.8%; 75 mg, 15.7%) versus placebo (−2.3%; least squares mean ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40976534/

Real world effectiveness and safety of oral Janus kinase ... Conclusion: Oral JAKi were effective and safe for patients with vitiligo. Patients taking oral JAKi for more than 6 months had better outcomes ...

5. jaad.org jaad.org/article/S0190-9622(24)02822-6/fulltext

Systemic Janus kinase inhibitor treatment for vitiligo Mean improvements in Total Vitiligo Area and Severity Index (T-VASI) were observed with tofacitinib (78.2%, n = 20), baricitinib (48.2%, n = 9), ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07108283

A Study of Zasocitinib in Adults With Nonsegmental Vitiligo A phase of research to describe clinical trials that focus on the safety of a drug. They are usually conducted with healthy volunteers, and the goal is to ...

7. practicaldermatology.com practicaldermatology.com/news/zasocitinib-effecgive-in-tyk2-inhibition-for-inflammatory-skin-disease/2474891/

Zasocitinib Effective in TYK2 Inhibition for Inflammatory ... "The long-term safety and efficacy of zasocitinib are being assessed in ongoing phase 3 clinical trials in moderate-to-severe plaque psoriasis.".

8. drugtargetreview.com drugtargetreview.com/article/187029/inside-zasocitinib-a-new-model-for-tyk2-inhibition-in-immune-mediated-diseases/

Inside Zasocitinib: a new model for TYK2 inhibition in ... Zasocitinib, a selective TYK2 inhibitor by Takeda, shows promise as a targeted oral therapy for immune-mediated inflammatory diseases.

9. dermatologytimes.com dermatologytimes.com/view/phase-2b-trial-reinforces-zasocitinib-s-safety-profile

Phase 2b Trial Reinforces Zasocitinib's Safety Profile Melinda Gooderham, MSc, MD, FRCPC, emphasized the significance of the study's results, showcasing stable laboratory parameters over a 12-week ...