Study to Evaluate the Efficacy and Safety of Deuruxolitinib in Japanese Adults With Severe Alopecia Areata (THRIVE-AAJP)

A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Deuruxolitinib in Adult Patients With Severe Alopecia Areata With an Open-Label Extension Period

This study evaluates the efficacy and safety of deuruxolitinib in Japanese Adults between 18 and 65 years of age who have 50% or greater scalp hair loss.

Study Overview

• Status: Not yet recruiting
• Conditions: Alopecia Areata
• Intervention / Treatment: Drug: Deuruxolitinib; Drug: Placebo

Detailed Description

The efficacy and safety of deuruxolitinib in adult subjects with severe alopecia areata will be evaluated in this study, beginning with a double-blind, randomized, placebo-controlled Treatment Period of 24 weeks. Subjects between 18 and 65 years of age having at least 50% hair loss as measured by SALT and meeting eligibility criteria will be randomized to deuruxolitinib or placebo treatment. In the Open-label Extension part of the study, all participants from the Treatment Period will receive deuruxolitinib for 52 weeks.

• Study Type: Interventional
• Enrollment (Estimated): 78
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Written informed consent has been obtained.
• Japanese subjects with severe alopecia areata who are between 18 and 65 years of age, inclusive, at the time of informed consent.
• Definitive diagnosis of alopecia areata with a current episode of scalp hair loss lasting at least 6 months.
• SALT score of 50 or more at both Screening and Baseline.

Exclusion Criteria:

• Treatment with systemic immunosuppressive medications or agents, including Janus kinase inhibitors, within 4 months prior to randomization.
• Treatment with biologics within 6 months prior to Screening.
• Positive test results for hepatitis B virus, hepatitis C virus, or human immunodeficiency virus at Screening.
• History of active tuberculosis, a positive interferon gamma release assay at Screening, or evidence of tuberculosis-related lesions on chest radiography.
• Clinically significant hematologic abnormalities, hepatic impairment, or renal impairment at Screening.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Deuruxolitinib 8 mg; Participants in this arm will receive deuruxolitinib 8 mg administered orally twice daily (BID) during the 24-week double-blind treatment period and continue to receive deuruxolitinib 8 mg administered orally BID up to 52 weeks	Drug: Deuruxolitinib; Deuruxolitinib will be dosed orally as tablets at a dose of 8 mg
Placebo Comparator: Placebo; Participants in this arm will receive matching placebo administered orally BID during the 24-week double-blind treatment period and then receive deuruxolitinib 8 mg administered orally BID up to 52 weeks.	Drug: Placebo; Deuruxolitinib matching placebo will be dosed orally as tablets for up to 24 weeks and then deuruxolitinib will be dosed for up to 52 weeks; Other Names: Deuruxolitinib

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of subjects achieving an absolute SALT score of 20 or less	SALT is a quantitative assessment of scalp hair loss with scores ranging in severity from 0 (no scalp hair loss) to a maximum of 100 (complete scalp hair loss).	Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of responders (defined as "satisfied" or "very satisfied") on the Satisfaction of Hair Patient Reported Outcome (SPRO) scale	SPRO is a questionnaire answered by the participant and designed to measure how satisfied alopecia areata participants are with their hair at the time of the assessment. The responses range from 1 to 5: 1= very satisfied, 2= satisfied, 3= neither satisfied nor dissatisfied, 4= dissatisfied, and 5= very dissatisfied. Higher scores indicate the greater hair dissatisfaction.	Week 24
Percentage of subjects achieving an absolute SALT score of 20 or less	SALT is a quantitative assessment of scalp hair loss with scores ranging in severity from 0 (no scalp hair loss) to a maximum of 100 (complete scalp hair loss).	Weeks 12, 16, and 20
Relative change in SALT scores from baseline	SALT is a quantitative assessment of scalp hair loss with scores ranging in severity from 0 (no scalp hair loss) to a maximum of 100 (complete scalp hair loss).	Weeks 4, 8, 12, 16, 20, and 24
Percentage of responders (defined as "much improved" or "very much improved") using the CGI-I	The CGI-I is a questionnaire that asks the clinician to evaluate the improvement or worsening of the participant's alopecia areata as compared to the start of the study on a 7-point scale. Responses range from 1 (very much worse) to 7 (very much improved). Responders will defined as participants with responses of 6 (much improved) or 7 (very much improved).	Weeks 12, 16, 20, and 24
Percentage of responders (defined as "much improved" or "very much improved") using the PGI-I	The PGI-I is a self-administered questionnaire that asks the participant to evaluate the improvement or worsening of their alopecia areata as compared to the start of the study on a 7-point scale. Responses range from 1 (very much worse) to 7 (very much improved). Responders will be defined as participants with responses of 6 (much improved) or 7 (very much improved).	Weeks 12, 16, 20, and 24
Change from baseline in CGI-S	The CGI-S is a questionnaire that asks the clinician to evaluate the symptom severity of the participant's alopecia areata at the time of assessment. The symptom severity was rated on a scale ranging from 1 to 7, where 1=normal, no hair loss; 2=borderline hair loss; 3=mild hair loss; 4=moderate hair loss; 5=marked hair loss; 6=severe hair loss; 7=among the most extreme hair loss. Higher scores indicate more hair loss. A negative change from baseline indicates less hair loss.	Weeks 12, 16, 20, and 24
Change from baseline in PGI-S	The PGI-S is a self-administered questionnaire that asks the participant to evaluate the symptom severity of their alopecia areata at the time of assessment. Symptom severity was rated on a scale ranging from 1 to 7, where 1=normal, no hair loss; 2=borderline hair loss; 3=mild hair loss; 4=moderate hair loss; 5=marked hair loss; 6=severe hair loss; 7=among the most extreme hair loss. Higher scores indicate more hair loss. A negative change from baseline indicates less hair loss.	Weeks 12, 16, 20, and 24
Percentage of subjects achieving at least a 75% relative reduction in SALT score from baseline	SALT is a quantitative assessment of scalp hair loss with scores ranging in severity from 0 (no scalp hair loss) to a maximum of 100 (complete scalp hair loss).	Weeks 12 and 24
Percentage of subjects achieving at least a 90% relative reduction in SALT score from baseline	SALT is a quantitative assessment of scalp hair loss with scores ranging in severity from 0 (no scalp hair loss) to a maximum of 100 (complete scalp hair loss).	Weeks 12 and 24
Percentage of responders (defined as "satisfied" or "very satisfied") on the Satisfaction of Hair Patient Reported Outcome (SPRO) scale	SPRO is a questionnaire answered by the participant and designed to measure how satisfied alopecia areata participants are with their hair at the time of the assessment. The responses range from 1 to 5: 1= very satisfied, 2= satisfied, 3= neither satisfied nor dissatisfied, 4= dissatisfied, and 5= very dissatisfied. Higher scores indicate the greater hair dissatisfaction.	Weeks 12, 16, and 20
Change from baseline in SPRO scale	SPRO is a questionnaire answered by the participant and designed to measure how satisfied alopecia areata participants are with their hair at the time of the assessment. The responses range from 1 to 5: 1= very satisfied, 2= satisfied, 3= neither satisfied nor dissatisfied, 4= dissatisfied, and 5= very dissatisfied. Higher scores indicate the greater hair dissatisfaction.	Weeks 12, 16, 20, and 24
Percentage of subjects achieving a 2-point or greater improvement from baseline in SPRO scale	SPRO is a questionnaire answered by the participant and designed to measure how satisfied alopecia areata participants are with their hair at the time of the assessment. The responses range from 1 to 5: 1= very satisfied, 2= satisfied, 3= neither satisfied nor dissatisfied, 4= dissatisfied, and 5= very dissatisfied. Higher scores indicate the greater hair dissatisfaction.	Weeks 12, 16, 20, and 24
Change from baseline on the individual items of the Quality of Hair Patient Reported Outcome (QPRO) scale	The QPRO questionnaire provides additional details on key attributes of hair and helps provide context to the SPRO response. The individual items of QPRO are: Satisfied thickness hair coverage; Satisfied evenness hair coverage; How satisfied with your eyebrows; How satisfied with your eyelashes, scored on a scale ranging from 1 to 5 where 1=very satisfied, 2=satisfied, 3=neither satisfied nor dissatisfied, 4=dissatisfied, 5=very dissatisfied. Higher scores indicate the greater dissatisfaction on hair quality. A negative change from baseline indicate the greater satisfaction on hair quality.	Weeks 12, 16, 20, and 24
Change from baseline in the depression scale of the Hospital Anxiety and Depression Scale (HADS)	HADS is a questionnaire designed to assess anxiety and depression symptoms which is completed by participants. The questionnaire is comprised of two separate scales with a total of 14 items: A 7-item scale related to anxiety and 7-item scale related to depression. Each item within both scales is scored using a 4-point scale, ranging from 0 to 3 and the total scores in each scale can range from 0 to 21. Separate scores were created for anxiety and depression. A score between 0-7 is considered normal, 8-10 is mild, 11-14 is moderate, and >14 is severe anxiety or depression. Higher scores indicate greater severity. A negative change from baseline indicates less severity.	Week 24
Change from baseline in the anxiety scale of the Hospital Anxiety and Depression Scale (HADS)	HADS is a questionnaire designed to assess anxiety and depression symptoms which is completed by participants. The questionnaire is comprised of two separate scales with a total of 14 items: A 7-item scale related to anxiety and 7-item scale related to depression. Each item within both scales is scored using a 4-point scale, ranging from 0 to 3 and the total scores in each scale can range from 0 to 21. Separate scores were created for anxiety and depression. A score between 0-7 is considered normal, 8-10 is mild, 11-14 is moderate, and >14 is severe anxiety or depression. Higher scores indicate greater severity. A negative change from baseline indicates less severity.	Week 24
Percentage of subjects achieving an absolute SALT score of 20 or less	SALT is a quantitative assessment of scalp hair loss with scores ranging in severity from 0 (no scalp hair loss) to a maximum of 100 (complete scalp hair loss).	Weeks 4 and 8
Percentage of subjects achieving an absolute SALT score of 10 or less	SALT is a quantitative assessment of scalp hair loss with scores ranging in severity from 0 (no scalp hair loss) to a maximum of 100 (complete scalp hair loss).	Weeks 4, 8, 12, 16, 20, and 24
Change from baseline in the Eyebrow Clinician-Reported Outcome (ClinRO) score	The Clinician-Reported Outcome Measure of Eyebrow Hair is a clinician-rated scale that assesses the total eyebrow hair present, with scores ranging from 0 to 3. A score of 0 indicates full eyebrow coverage with no areas of hair loss, and a score of 3 indicates no notable eyebrow hair. Higher scores indicate worse outcomes (greater hair loss).	Weeks 12 and 24
Change from baseline in the Eyelash Clinician-Reported Outcome (ClinRO) score	The Clinician-Reported Outcome Measure of Eyelash Hair is a clinician-rated scale that assesses the total eyelash hair present, with scores ranging from 0 to 3. A score of 0 indicates that eyelashes form a continuous line along the eyelids on both eyes, and a score of 3 indicates no notable eyelashes. Higher scores indicate worse outcomes (greater hair loss).	Weeks 12 and 24

Collaborators and Investigators

• Sponsor: Sun Pharma Japan Limited

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): September 1, 2028

Study Registration Dates

• First Submitted: May 22, 2026
• First Submitted That Met QC Criteria: May 22, 2026
• First Posted (Actual): June 1, 2026

Study Record Updates

• Last Update Posted (Actual): June 4, 2026
• Last Update Submitted That Met QC Criteria: June 2, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: JAK inhibitor; hair loss; alopecia areata; severe alopecia areata; deuruxolitinib
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Skin Diseases; Hypotrichosis; Hair Diseases; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Alopecia Areata; Alopecia
• Other Study ID Numbers: CTP-543-25-01JP; jRCT2031260062 (Registry Identifier: Japan Registry of Clinical Trials (jRCT))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No