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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04556734
Recruitment Status : Active, not recruiting
First Posted : September 21, 2020
Last Update Posted : February 14, 2023
Sponsor:
Collaborator:
Arena is a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
Pfizer

Study Description
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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).

Condition or disease Intervention/treatment Phase
Alopecia Areata Drug: Etrasimod Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double-Blind, Placebo-Controlled
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : July 29, 2020
Estimated Primary Completion Date : June 6, 2023
Estimated Study Completion Date : June 6, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Etrasimod 2 mg Drug: Etrasimod
Etrasimod 2 mg tablet by mouth, once daily
Other Name: APD334
Experimental: Etrasimod 3 mg Drug: Etrasimod
Etrasimod 3 mg (1 mg and 2 mg tablets) by mouth, once daily
Other Name: APD334
Placebo Comparator: Placebo Drug: Placebo
Etrasimod matching placebo tablet by mouth, once daily


Outcome Measures
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Primary Outcome Measures :
  1. Percent Change From Baseline in Severity of Alopecia Tool (SALT) [ Time Frame: Baseline to Week 24 ]

Secondary Outcome Measures :
  1. Change From Baseline in SALT [ Time Frame: Baseline to Week 24 ]
  2. Proportion of Participants Achieving ≥30% Improvement From Baseline in SALT [ Time Frame: Baseline to Week 24 ]
  3. Proportion of Participants Achieving ≥50% Improvement From Baseline in SALT [ Time Frame: Baseline to Week 24 ]
  4. Proportion of Participants Achieving ≥75% Improvement From Baseline in SALT [ Time Frame: Baseline to Week 24 ]
  5. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04556734


Locations
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Sponsors and Collaborators
Pfizer
Arena is a wholly owned subsidiary of Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT04556734    
Other Study ID Numbers: APD334-205
C5041008 ( Other Identifier: Alias Study Number )
First Posted: September 21, 2020    Key Record Dates
Last Update Posted: February 14, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pfizer:
T-cell-mediated autoimmune skin disorder
Alopecia areata
Alopecia
 APD334
Etrasimod
Hair loss
Additional relevant MeSH terms:
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Alopecia
Alopecia Areata
Hypotrichosis
 Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical