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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03898479




Registration number
NCT03898479
Ethics application status
Date submitted
29/03/2019
Date registered
2/04/2019
Date last updated
1/10/2024

Titles & IDs
Public title
Extension Study to Evaluate Safety and Efficacy of CTP-543 in Adults With Alopecia Areata
Scientific title
A Multicenter, Open-Label, Extension Study to Assess the Long-Term Safety and Efficacy of CTP-543 in Adult Patients With Moderate to Severe Alopecia Areata
Secondary ID [1] 0 0
CP543.5001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alopecia Areata 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - CTP-543

Experimental: CTP-543 - Patients who previously completed a qualifying CTP-543 clinical trial


Treatment: Drugs: CTP-543
Twice daily dosing
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants with Adverse Events as a Measure of Safety
Timepoint [1] 0 0
332 weeks
Primary outcome [2] 0 0
Effect of CTP-543 on treating hair loss as measured by the Severity of Alopecia Tool (SALT)
Timepoint [2] 0 0
332 weeks

Eligibility
Key inclusion criteria
* Have completed 24 weeks of treatment in a previous qualifying CTP-543 clinical trial
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Active scalp inflammation, psoriasis, or seborrheic dermatitis requiring topical treatment to the scalp, significant trauma to the scalp, or untreated actinic keratosis
* Females who are nursing, pregnant, or planning to become pregnant while in the study, and for 30 days after last dose of study medication
* Donation of blood at any point throughout the study and for 30 days after last dose of study medication

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/04/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/05/2025
Actual
Sample size
Target
1000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
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United States of America
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Alabama
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United States of America
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Arizona
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Arkansas
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California
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Colorado
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Connecticut
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Florida
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Idaho
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Illinois
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Indiana
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Kentucky
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Massachusetts
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Michigan
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Minnesota
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Nevada
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New Jersey
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New York
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North Carolina
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Ohio
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Oklahoma
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Oregon
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Pennsylvania
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Rhode Island
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South Carolina
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Texas
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Utah
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Virginia
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Wisconsin
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Canada
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Alberta
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Canada
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British Columbia
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Canada
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Manitoba
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Canada
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Ontario
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Canada
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Quebec
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Canada
State/province [34] 0 0
Québec

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Concert Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The overall objectives of the study are to evaluate long-term safety of CTP-543 and to assess long-term effects of CTP-543 on treating hair loss in adult patients with chronic, moderate to severe alopecia areata.
Trial website
https://clinicaltrials.gov/study/NCT03898479
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
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Address 0 0
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Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
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Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03898479