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Safety and Efficacy of Oral Etrasimod in Adult Participants With Moderate-to-Severe Alopecia Areata

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ClinicalTrials.gov Identifier: NCT04556734
Recruitment Status : Recruiting
First Posted : September 21, 2020
Last Update Posted : September 28, 2021
Sponsor:
Information provided by (Responsible Party):
Arena Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE September 15, 2020
First Posted Date  ICMJE September 21, 2020
Last Update Posted Date September 28, 2021
Actual Study Start Date  ICMJE August 31, 2020
Estimated Primary Completion Date May 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 15, 2020)
Percent Change From Baseline in Severity of Alopecia Tool (SALT) [ Time Frame: Baseline to Week 24 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 11, 2021)
  • Change From Baseline in SALT [ Time Frame: Baseline to Week 24 ]
  • Proportion of Participants Achieving ≥30% Improvement From Baseline in SALT [ Time Frame: Baseline to Week 24 ]
  • Proportion of Participants Achieving ≥50% Improvement From Baseline in SALT [ Time Frame: Baseline to Week 24 ]
  • Proportion of Participants Achieving ≥75% Improvement From Baseline in SALT [ Time Frame: Baseline to Week 24 ]
  • Number and Severity of Adverse Events (Double-Blind Treatment Period and Open-Label Extension Period) [ Time Frame: Up to approximately 56 weeks (24-weeks of Double-Blind Treatment Period, 28-weeks of Open-Label Extension Period, and 4-weeks of Safety Follow-Up Period) ]
    Safety will be assessed by monitoring adverse events and clinically relevant changes in vital signs and clinical laboratory results.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 15, 2020)
  • Change From Baseline in SALT [ Time Frame: Baseline to Week 24 ]
  • Proportion of Participants Achieving a 30% Improvement From Baseline in SALT (SALT30) [ Time Frame: Baseline to Week 24 ]
  • Proportion of Participants Achieving a 50% Improvement From Baseline in SALT (SALT50) [ Time Frame: Baseline to Week 24 ]
  • Proportion of Participants Achieving a 75% Improvement From Baseline in SALT (SALT75) [ Time Frame: Baseline to Week 24 ]
  • Number and Severity of Adverse Events (Double-Blind Treatment Period and Open-Label Extension Period) [ Time Frame: Up to approximately 56 weeks (24-weeks of Double-Blind Treatment Period, 28-weeks of Open-Label Extension Period, and 4-weeks of Safety Follow-Up Period) ]
    Safety will be assessed by monitoring adverse events and clinically relevant changes in vital signs and clinical laboratory results.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of Oral Etrasimod in Adult Participants With Moderate-to-Severe Alopecia Areata
Official Title  ICMJE A Multicenter, Randomized, Double-Blind, Placebo-Controlled, 24-Week Study, With a 28-Week Open-Label Extension, to Assess the Safety and Efficacy of Etrasimod in Subjects With Moderate-to-Severe Alopecia Areata
Brief Summary The purpose of this study is to evaluate the safety and efficacy of etrasimod monotherapy (2 milligrams [mg] and 3 mg) in participants with moderate-to-severe alopecia areata (AA).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Double-Blind, Placebo-Controlled
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Alopecia Areata
Intervention  ICMJE
  • Drug: Etrasimod
    Etrasimod 2 mg tablet by mouth, once daily
    Other Name: APD334
  • Drug: Etrasimod
    Etrasimod 3 mg (1 mg and 2 mg tablets) by mouth, once daily
    Other Name: APD334
  • Drug: Placebo
    Etrasimod matching placebo tablet by mouth, once daily
Study Arms  ICMJE
  • Experimental: Etrasimod 2 mg
    Intervention: Drug: Etrasimod
  • Experimental: Etrasimod 3 mg
    Intervention: Drug: Etrasimod
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 11, 2021)
78
Original Estimated Enrollment  ICMJE
 (submitted: September 15, 2020)
36
Estimated Study Completion Date  ICMJE October 2023
Estimated Primary Completion Date May 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  • Men or women between ≥18 and ≤70 years of age at the time of informed consent
  • Moderate-to-severe alopecia areata as assessed by a SALT score of ≥25 and <95 at Screening and Day 1/Baseline.
  • Current episode of hair loss for ≥6 months but <5 years
  • Stable disease condition (no significant growth of hair) in the last 6 months as assessed by the Investigator
  • Willing to keep the same hair style and color (eg, hair products, process, and timing for hair appointments) for the duration of the study

Key Exclusion Criteria:

  • History of male or female pattern hair loss >Hamilton stage III or >Ludwig stage II
  • Other types of alopecia (eg, cicatricial/scarring alopecia [including central centrifugal cicatricial alopecia], traction alopecia, or telogen effluvium) or other diseases that could cause hair loss
  • Active scalp inflammation, scalp infection, scalp psoriasis, or any other scalp condition that may interfere with the SALT assessment
  • Previous use of Janus kinase (JAK) inhibitor (oral or topical), including participation in clinical studies of JAK inhibitors
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Arena CT.gov Administrator +1 855-218-9153 ct.gov@arenapharm.com
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04556734
Other Study ID Numbers  ICMJE APD334-205
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Arena Pharmaceuticals
Study Sponsor  ICMJE Arena Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Arena CT.gov Administrator Arena Pharmaceuticals
PRS Account Arena Pharmaceuticals
Verification Date September 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP