Deuruxolitinib for Alopecia Areata

Recruiting at 21 trial locations

Overseen By Head Regulatory Affairs

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: Sun Pharmaceutical Industries, Inc.

Must not be taking: Hair regrowth, Immune response

Disqualifiers: Scalp inflammation, Psoriasis, Pregnancy, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Compensation: Varies

Number of Visits: 4

Duration: 24 weeks

355 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called deuruxolitinib, a JAK inhibitor, for teenagers who have lost at least half of their scalp hair due to alopecia areata, a condition where the immune system attacks hair follicles. The study aims to determine if deuruxolitinib is safe and effective in promoting hair regrowth. Participants will take either the actual drug or a placebo (a pill with no active drug) for up to 24 weeks, with an option for an extended period. Those who have had alopecia areata for at least 6 months and can meet study requirements might be suitable for this trial. As a Phase 3 trial, this study represents the final step before potential FDA approval, offering participants a chance to contribute to a promising treatment's journey to market.

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

Yes, you will need to stop taking any medications that might affect hair regrowth or immune response at least 28 days before starting the trial and during the study.

Is there any evidence suggesting that deuruxolitinib is likely to be safe for adolescents?

Research has shown that deuruxolitinib is generally well-tolerated in adults. One study found that patients taking deuruxolitinib did not encounter any new safety issues, with nothing unexpected or unusually harmful reported. Another source confirmed this, stating that a detailed safety review found no new concerns for those using the medication.

Deuruxolitinib is a Janus kinase (JAK) inhibitor. JAK inhibitors are often used to treat alopecia areata, a condition that causes hair loss, and have been studied for their safety. Overall, evidence suggests that deuruxolitinib is safe to use, with no new risks identified in the studies conducted.

Since this trial is in a late phase, it indicates that the treatment has already demonstrated a good level of safety in earlier studies. However, it's important to remember that all medications can have some side effects, and people may experience them differently. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for alopecia areata?

Researchers are excited about Deuruxolitinib for alopecia areata because it offers a new approach to tackling this condition. Unlike traditional treatments like corticosteroids or topical immunotherapy, which can have varied results and side effects, Deuruxolitinib is a JAK inhibitor. It works by specifically targeting the pathways involved in the autoimmune attack on hair follicles, potentially leading to more effective and predictable hair regrowth. This targeted mechanism of action could provide a more reliable solution for those struggling with alopecia areata.

What evidence suggests that deuruxolitinib might be an effective treatment for alopecia areata?

Research has shown that deuruxolitinib holds promise for treating alopecia areata, particularly in individuals with significant hair loss. In earlier studies, many adults who had lost 50% or more of their scalp hair reduced this to 20% or less after 24 weeks of treatment, indicating significant hair regrowth. In this trial, participants will receive either deuruxolitinib or a placebo for up to 24 weeks. Deuruxolitinib has demonstrated strong short-term results, outperforming other similar treatments. Overall, the treatment has proven effective and safe for adults, which is a positive sign for its potential use in teenagers. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

Adolescents aged 12 to less than 18 with severe alopecia areata, having lost 50% or more of their scalp hair. Specific inclusion and exclusion criteria details were not provided.

Inclusion Criteria

Willing to comply with the study visits and requirements of the study protocol

At least 50% scalp hair loss, as defined by a Severity of Alopecia Tool (SALT) score ≥50

I am between 12 and 17 years old.

Exclusion Criteria

Clinically significant medical condition, psychiatric disease, or social condition, as determined by the Investigator, that may unfavorably alter the risk-benefit of study participation, adversely affect study compliance, or confound interpretation of study results

I don't have scalp conditions like psoriasis or injuries that could affect hair loss assessment.

I haven't taken any medication in the last 28 days that could affect hair growth or my immune system.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive deuruxolitinib or placebo for 24 weeks in a double-blind, randomized, placebo-controlled manner

24 weeks

Visits at Weeks 4, 8, 12, 16, 20, and 24

Open-label Extension

Participants receive deuruxolitinib for an additional 52 weeks

52 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Deuruxolitinib

Trial Overview

The trial is testing the safety and effectiveness of a medication called Deuruxolitinib compared to a placebo in treating severe alopecia areata in adolescents.

How Is the Trial Designed?

Group I: Treatment Period: Deuruxolitinib 8 mg Experimental Treatment 1 Intervention

Deuruxolitinib tablets, orally, twice daily (BID) for up to 24 weeks

Group II: Open-Label Extension: Deuruxolitinib 8 mg BID Experimental Treatment 1 Intervention

Deuruxolitinib tablets, orally, BID for up to 52 weeks

Group III: Treatment Period: Placebo Placebo Group 1 Intervention

Deuruxolitinib-matched placebo tablets, orally, BID for up to 24 weeks

Who Is Running the Clinical Trial?

Sun Pharmaceutical Industries, Inc.

Lead Sponsor

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12539349/

PMC - PubMed Central

In conclusion, deuruxolitinib shows promising efficacy in treating moderate to severe AA, leading to significant improvements in hair regrowth and patient- ...

2.

jaad.org

jaad.org/article/S0190-9622(24)02550-7/fulltext

Efficacy and safety of deuruxolitinib, an oral selective ...

Significant proportions of adult patients with alopecia areata and ≥50% scalp hair loss achieved ≤20% scalp hair loss during 24 weeks of ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07133308

NCT07133308 | Study to Evaluate the Efficacy and Safety ...

This study evaluates the safety and effectiveness of deuruxolitinib in adolescents aged 12 to less than 18 years who have 50% or greater scalp hair loss.

4.

ajmc.com

ajmc.com/view/deuruxolitinib-demonstrates-efficacy-safety-in-adults-with-alopecia-areata

Deuruxolitinib Demonstrates Efficacy, Safety in Adults With ...

Deuruxolitinib showed significant efficacy and safety in hair regrowth stimulation among adult patients with alopecia areata, particularly in those with ...

5.

hcplive.com

hcplive.com/view/deuruxolitinib-greatest-short-term-efficacy-among-jakis-severe-alopecia-areata

Deuruxolitinib Shows Greatest Short-Term Efficacy Among ...

Deuruxolitinib 8 mg BID shows superior short-term efficacy among approved oral JAK inhibitors for severe alopecia areata. The study fills a ...

6.

accessdata.fda.gov

accessdata.fda.gov/drugsatfda_docs/nda/2024/217900Orig1s000MultidisciplineR.pdf

217900Orig1s000 MULTI-DISCIPLINE REVIEW Summary ...

Expectations on Safety in the Postmarket Setting. The comprehensive analysis of the deuruxolitinib safety data identified no new safety signals.

7.

ajmc.com

ajmc.com/view/analyzing-the-safety-data-of-jak-inhibitors

Analyzing the Safety Data of JAK Inhibitors

Panelists discuss the key safety data observed with each of the three Janus kinase (JAK) inhibitors for alopecia areata (AA), highlighting ...

8.

ncbi.nlm.nih.gov

ncbi.nlm.nih.gov/books/NBK609110/

Deuruxolitinib - LiverTox - NCBI Bookshelf - NIH

Deuruxolitinib is an orally available small molecule inhibitor of Janus kinases that is used to treat severe alopecia areata.