Deucravacitinib for Alopecia Areata

Recruiting at 46 trial locations

Overseen By BMS Study Connect Contact Center www.BMSStudyConnect.com

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Bristol-Myers Squibb

Disqualifiers: Diffuse alopecia, Traction alopecia, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

94 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a medication called Deucravacitinib to see if it can help adults with Alopecia Areata, a condition where people lose hair in patches. The study will compare the effects of Deucravacitinib to another treatment over several months. The goal is to find out if the medication is effective and safe.

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

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.

Is Deucravacitinib safe for humans?

The available research does not provide specific safety data for Deucravacitinib in humans, but it has been approved in Canada, suggesting some level of safety evaluation has been conducted. ^{1 2 3 4 5}

How is the drug deucravacitinib different from other treatments for alopecia areata?

Deucravacitinib is unique because it is a selective TYK2 inhibitor, which is a different mechanism of action compared to other treatments like tofacitinib and ruxolitinib that target the Janus kinase pathway. This drug has shown rapid hair regrowth in cases resistant to other treatments, suggesting it could be a promising new option for alopecia areata. ^{5 6 7 8 9}

Research Team

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Eligibility Criteria

This trial is for adults with Alopecia Areata who've had the condition for at least 6 months, with current hair loss affecting over half their scalp and stable for the past 6 months. They should have a SALT score of at least 50, indicating significant hair loss. Those with other types of hair loss or skin conditions that could affect scalp assessment can't participate.

Inclusion Criteria

You have a high score for scalp hair loss, and if you have complete scalp hair loss, you may still be included.

My current scalp hair loss has lasted at least 6 months but not more than 8 years, and hasn't improved significantly in the last 6 months.

You have a SALT score of at least 50, which measures the amount of scalp hair loss. If you have complete scalp hair loss (SALT score of 100), with or without body hair loss, you can still participate.

Exclusion Criteria

I do not have skin conditions on my scalp that could affect hair loss evaluation.

You have a lot of tattoos on your scalp that could make it hard for the doctor to measure your skin condition accurately.

I have a type of hair loss such as diffuse AA or traction alopecia.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Placebo-Controlled Treatment

Participants receive either deucravacitinib or placebo to evaluate efficacy and safety

24 weeks

Regular visits for monitoring and assessments

Active Treatment

Participants receive active treatment with deucravacitinib to further assess safety and efficacy

28 weeks

Regular visits for monitoring and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Deucravacitinib
• Placebo

Trial Overview The study is testing Deucravacitinib's effectiveness compared to a placebo in improving symptoms by Week 24. Participants will be randomly assigned to receive either Deucravacitinib or a placebo, allowing researchers to measure the drug's true impact on Alopecia Areata.

Participant Groups

Group I: Deucravacitinib Dose 2 Experimental Treatment 2 Interventions

Group II: Deucravacitinib Dose 1 Experimental Treatment 2 Interventions

Group III: Placebo, followed by Deucravacitinib Dose 1 or Dose 2. Placebo Group 2 Interventions

Deucravacitinib is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Sotyktu for:

• Moderate to severe plaque psoriasis

Approved in European Union as Sotyktu for:

• Moderate to severe plaque psoriasis

Approved in Canada as Sotyktu for:

• Moderate to severe plaque psoriasis

Who Is Running the Clinical Trial?

Bristol-Myers Squibb

Lead Sponsor

Trials

2,731

Recruited

4,127,000+

Headquarters

New York City, USA

Known For

Oncology & Cardiovascular

Top Products

Eliquis, Opdivo, Revlimid, Orencia

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania

Findings from Research

Baricitinib, a JAK inhibitor, is the first approved treatment for severe alopecia areata, showing significant hair regrowth in scalp, eyebrows, and eyelashes over 36 weeks in two phase 3 clinical trials.

The drug was generally well tolerated, with common side effects including infections and headaches, indicating it is a promising option for patients suffering from this challenging condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Baricitinib: A Review in Severe Alopecia Areata. Fung, S., Shirley, M.[2023]

In the phase 2a ALLEGRO trial involving 142 adults with alopecia areata, both ritlecitinib and brepocitinib significantly improved patient-reported outcomes (AASIS scores) and clinician-assessed hair loss (SALT scores) after 24 weeks compared to placebo.

The study found medium-to-large correlations between patient-reported outcomes and clinician assessments, indicating that both measures are important for evaluating treatment effectiveness in alopecia areata.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterizing the relationships between patient-reported outcomes and clinician assessments of alopecia areata in a phase 2a randomized trial of ritlecitinib and brepocitinib. Winnette, R., Banerjee, A., Sikirica, V., et al.[2022]

In a long-term study involving two patients with alopecia areata, oral ruxolitinib led to sustained, near-complete hair regrowth over a year without any significant side effects.

The results suggest that ruxolitinib is a safe and effective treatment option for individuals with alopecia who do not respond to other therapies, warranting its consideration in community dermatology settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Two cases of alopecia areata treated with ruxolitinib: a discussion of ideal dosing and laboratory monitoring. Vandiver, A., Girardi, N., Alhariri, J., et al.[2021]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Baricitinib: A Review in Severe Alopecia Areata. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Real-world experience and long-term evaluation of tofacitinib in refractory alopecia areata: A prospective, open-label, single-center study in Asian Arab population. [2023]

3. Germany pubmed.ncbi.nlm.nih.gov

A phase 2a randomized vehicle-controlled multi-center study of the safety and efficacy of delgocitinib in subjects with moderate-to-severe alopecia areata. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Characterizing the relationships between patient-reported outcomes and clinician assessments of alopecia areata in a phase 2a randomized trial of ritlecitinib and brepocitinib. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Rapid hair regrowth in an alopecia universalis patient with deucravacitinib: A case report. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Current Treatment of Alopecia Areata. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Tofacitinib for the Treatment of Severe Alopecia Areata in Adults and Adolescents. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Successful Treatment of Severe Alopecia Areata With Oral or Topical Tofacitinib. [2018]

9. England pubmed.ncbi.nlm.nih.gov

Two cases of alopecia areata treated with ruxolitinib: a discussion of ideal dosing and laboratory monitoring. [2021]