A Study of KL130008 in Adults With Severe Alopecia Areata

NCT ID: NCT05496426

Last Updated: 2022-08-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 176 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-31
• Study Completion Date: 2024-12-31

Brief Summary

The purpose of this study is to assess KL130008 is safe and effective in adults with severe alopecia areata

Detailed Description

This is a multi-center Phase 2 study to evaluate the safety and effectiveness of an investigational drug in adults (≥18 years and ≤65 years) who have 50% or greater scalp hair loss, including alopecia totalis (AT) and alopecia universalis (AU).

Conditions

Alopecia Areata

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

KL130008 capsule High Dose

KL130008 capsule administered orally

Group Type: EXPERIMENTAL

KL130008/Placebo

Intervention Type: DRUG

Drug: KL130008 Drug: Placebo

KL130008 capsule Middle Dose

KL130008 capsule administered orally

Group Type: EXPERIMENTAL

KL130008/Placebo

Intervention Type: DRUG

Drug: KL130008 Drug: Placebo

KL130008 capsule Low Dose

KL130008 capsule administered orally

Group Type: EXPERIMENTAL

KL130008/Placebo

Intervention Type: DRUG

Drug: KL130008 Drug: Placebo

Placebo

Placebo administered orally

Group Type: PLACEBO_COMPARATOR

KL130008/Placebo

Intervention Type: DRUG

Drug: KL130008 Drug: Placebo

Interventions

KL130008/Placebo

Drug: KL130008 Drug: Placebo

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Male or female subjects with the age of ≥18 and ≤ 65 years old at the time of informed consent.

2. Able to understand the procedures and methods of this study, and will to provide a signed and dated informed consent form.

3. Diagnosed alopecia areata(AA) without other reasons caused alopecia.

4. Have severe AA, as determined by all of the following:Current AA episode of more than 6 months' duration and hair loss encompassing ≥50% of the scalp, including alopecia totalis (AT) and alopecia universalis (AU);No spontaneous improvement over the past 6 months;Current episode of severe AA of less than 8 years.

5. All women of childbearing potential and all men must be willing to use at least one highly effective method of contraception from the signing of informed consent, throughout the duration of the study, and for 3 months after the last dose of investigational drugs.

Exclusion Criteria

1. Known history of anaphylaxis to any of the ingredients and/or other similar products.

2. Participated in a clinical trial of any drug or medical device and has used an investigational product (including placebo and control group) or treatment within 1 month or 5 half-lives before randomization.

3. Previously treated with JAK inhibitors.

4. Corticosteroids, finasteride, minoxidil,topical immunotherapy treated within 8 weeks before randomization.

5. Diphenylcyclopropenone (DPCP), HMGCoA reductase inhibitor, Chinese herbal medicine treated within 4 weeks before randomization.

6. With other diseases: acute "diffuse" type of AA, lymphoproliferative disease, tumor, severe chronic gastrointestinal disease, thyroid disorders, serious cardiovascular disease.

7. Subjects with evidence of clinical laboratory abnormalities at screening that, in the opinion of the investigator, may affect the safety of subjects or the interpretation of study results: Hemoglobin level < 10.0 g/dL. Absolute white blood cell (WBC) count /absolute neutrophil count (NEUT)/absolute lymphocyte count(LYMPH)<LLN. Aspartate aminotransferase (AST), or alanine aminotransferase (ALT) > 2 × ULN, total bilirubin(TBIL)>1.5 × ULN. QTcF> 450ms. Subjects with eGFR ≤ 60 mL/min based on Cockcroft-Gault calculation.

8. The subject had or currently has a severe infection, and had a severe infection judged by the investigator within 1 month before randomization: HBV, TP-Ab, HIV, HCV, TB positive.

9. Subjects who are unsuitable to the trial, as identified by the investigator.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xingqi Zhang

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital, Sun Yat-Sen University

Locations

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangzhou, China

Countries

China

Central Contacts

Xiaoli Cai

Role: CONTACT

caixl@kelun.com

021-60718153

Other Identifiers

CTR20221881

Identifier Type: REGISTRY

Identifier Source: secondary_id

KL223-II-05

Identifier Type: -

Identifier Source: org_study_id