Study to assess the long-term efficacy and safety following administration of CTP-543 in adult patients with moderate to severe alopecia areata

Phase 1

• Conditions: MODERATE TO SEVERE ALOPECIA AREATA IN ADULT PATIENTS; MedDRA version: 20.0Level: PTClassification code 10001761Term: Alopecia areataSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2021-002365-18-DE
• Lead Sponsor: Sun Pharmaceutical Industries, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-10-04
• Last Update Posted: 26 February 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 407

Inclusion Criteria

1.Written informed consent, and authorization for release and use of protected health information.
2.Have completed a 24-week Treatment Period in a previous qualifying CTP-543 clinical trial.
3.Female subjects are eligible to participate if at least one of the following conditions applies:
a)Is a woman of childbearing potential (WOCBP) and using a medically highly effective form of birth control with a failure rate less than 1% per year from at least 4 weeks prior to Baseline until at least 30 days following last dose of study drug. Examples of medically highly effective birth control methods include:
i.Combined (estrogen and progestogen containing) hormonal contraception (oral, patch, vaginal ring)
ii.Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable)
iii.Intrauterine device or intrauterine hormone-releasing system
iv.Bilateral tubal occlusion
v.Vasectomized partner (partner is the sole sexual partner of the WOCBP trial participant and the vasectomized partner has received medical assessment of the surgical success)
vi.Sexual abstinence (reliable as refraining from heterosexual intercourse during the above-mentioned period)
b) Is not a WOCBP:
i. Premenopausal with one of the following:
a. Documented hysterectomy;
b. Documented bilateral salpingectomy;
c. Documented bilateral oophorectomy.
ii. Postmenopausal (cessation of menses for at least 12 months prior to screening)
Postmenopausal is defined as no menses for 12 months without an alternative medical cause. In addition, a high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm postmenopausal in women under 60 years old and not using hormonal contraception or hormone replacement therapy (HRT). However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient. Females on HRT and whose menopausal status is in doubt will be required to use one of the nonestrogen hormonal highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of postmenopausal status before study enrollment
4.Male participants must:
a.Agree to use, with their partners, male contraception (condom) and one of the highly effective contraceptive methods listed in Inclusion Criterion 3, from Baseline until at least 90 days following last dose of study drug.
b.Refrain from donating sperm during the study and for at least 90 days after the end of the study.
5.Willing to comply with the study visits and requirements of the study protocol.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 403
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4

Exclusion Criteria

1.Active scalp inflammation, psoriasis, or seborrheic dermatitis requiring topical treatment to the scalp, significant trauma to the scalp, or other scalp condition that may interfere with the SALT assessment, or untreated actinic keratosis anywhere on the body.
2.Females who are nursing, pregnant, or planning to become pregnant while in the study, and for 30 days after last dose of study medication.
3.Donation of blood at any point throughout the study and for 30 days after last dose of study medication.
4.Most recent hematologic parameters do not permit continued dosing; i.e., criteria for withholding IP have been met and have not recovered to values required to resume dosing.
5.Any medical, psychiatric, or social condition that is likely to unfavorably affect the risk-benefit of continued study participation, interfere with study compliance, or confound safety or efficacy assessments.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified