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A Study of KL130008 in Adults With Severe Alopecia Areata

Primary Purpose

Alopecia Areata

Status

Not yet recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

KL130008/Placebo

About this trial

This is an interventional treatment trial for Alopecia Areata focused on measuring Alopecia Areata, Hypotrichosis, Hair Diseases

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or female subjects with the age of ≥18 and ≤ 65 years old at the time of informed consent.
Able to understand the procedures and methods of this study, and will to provide a signed and dated informed consent form.
Diagnosed alopecia areata(AA) without other reasons caused alopecia.
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.
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:

Known history of anaphylaxis to any of the ingredients and/or other similar products.
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.
Previously treated with JAK inhibitors.
Corticosteroids, finasteride, minoxidil,topical immunotherapy treated within 8 weeks before randomization.
Diphenylcyclopropenone (DPCP), HMGCoA reductase inhibitor, Chinese herbal medicine treated within 4 weeks before randomization.
With other diseases: acute "diffuse" type of AA, lymphoproliferative disease, tumor, severe chronic gastrointestinal disease, thyroid disorders, serious cardiovascular disease.
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.
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.
Subjects who are unsuitable to the trial, as identified by the investigator.

Sites / Locations

The First Affiliated Hospital of Sun Yat-sen University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

KL130008 capsule High Dose

KL130008 capsule Middle Dose

KL130008 capsule Low Dose

Placebo

Arm Description

KL130008 capsule administered orally

Placebo administered orally

Outcomes

Primary Outcome Measures

Percentage of Participants Achieving Severity of Alopecia Tool (SALT) ≤ 20 [ Time Frame: Week 24 ]

Percentage of Participants Achieving SALT ≤ 20

Secondary Outcome Measures

Percentage of Participants Achieving Severity of Alopecia Tool (SALT) ≤ 20 [ Time Frame: Week 36 ]

Percentage of Participants Achieving SALT ≤ 20

Percent Change from Baseline in SALT score [ Time Frame: Baseline, Week 24, 36 ]

Percent change from baseline in SALT score

Percentage of Participants Achieving 50% Improvement of Severity of Alopecia Tool (SALT50) [ Time Frame: Week 24, 36 ]

Percentage of participants achieving SALT50

Percentage of Participants Achieving 75% Improvement of Severity of Alopecia Tool (SALT50) [ Time Frame: Week 24, 36 ]

Percentage of participants achieving SALT75

Percentage of Participants Achieving Severity of Alopecia Tool (SALT) ≤ 10 [ Time Frame: Week 24, 36 ]

Percentage of Participants Achieving SALT ≤ 10

Measure for Eyebrow (EB) Hair Loss 0 or 1 with ≥2-point Improvement from Baseline [ Time Frame: Week 24, 36 ]

EB hair loss 0 or 1 with ≥2-point Improvement from Baseline

Measure for Eyelash (EL) Hair Loss 0 or 1 with ≥2-point Improvement from Baseline

EL hair loss 0 or 1 with ≥2-point Improvement from Baseline

Full Information

NCT ID

NCT05496426

First Posted

August 9, 2022

Last Updated

August 9, 2022

Sponsor

Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT05496426

Brief Title

A Study of KL130008 in Adults With Severe Alopecia Areata

Official Title

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Trial Evaluating the Safety and Efficacy of KL130008 Capsule in Patients With Severe Alopecia Areata

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

October 31, 2022 (Anticipated)

Primary Completion Date

December 31, 2024 (Anticipated)

Study Completion Date

December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alopecia Areata

Keywords

Alopecia Areata, Hypotrichosis, Hair Diseases

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

176 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

KL130008 capsule High Dose

Arm Type

Experimental

Arm Description

KL130008 capsule administered orally

Arm Title

KL130008 capsule Middle Dose

Arm Type

Experimental

Arm Description

KL130008 capsule administered orally

Arm Title

KL130008 capsule Low Dose

Arm Type

Experimental

Arm Description

KL130008 capsule administered orally

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo administered orally

Intervention Type

Drug

Intervention Name(s)

KL130008/Placebo

Intervention Description

Drug: KL130008 Drug: Placebo

Primary Outcome Measure Information:

Title

Percentage of Participants Achieving Severity of Alopecia Tool (SALT) ≤ 20 [ Time Frame: Week 24 ]

Description

Percentage of Participants Achieving SALT ≤ 20

Time Frame

Week 24

Secondary Outcome Measure Information:

Title

Percentage of Participants Achieving Severity of Alopecia Tool (SALT) ≤ 20 [ Time Frame: Week 36 ]

Description

Percentage of Participants Achieving SALT ≤ 20

Time Frame

Week 36

Title

Percent Change from Baseline in SALT score [ Time Frame: Baseline, Week 24, 36 ]

Description

Percent change from baseline in SALT score

Time Frame

Week 24, 36

Title

Percentage of Participants Achieving 50% Improvement of Severity of Alopecia Tool (SALT50) [ Time Frame: Week 24, 36 ]

Description

Percentage of participants achieving SALT50

Time Frame

Week 24, 36

Title

Percentage of Participants Achieving 75% Improvement of Severity of Alopecia Tool (SALT50) [ Time Frame: Week 24, 36 ]

Description

Percentage of participants achieving SALT75

Time Frame

Week 24, 36

Title

Percentage of Participants Achieving Severity of Alopecia Tool (SALT) ≤ 10 [ Time Frame: Week 24, 36 ]

Description

Percentage of Participants Achieving SALT ≤ 10

Time Frame

Week 24, 36

Title

Measure for Eyebrow (EB) Hair Loss 0 or 1 with ≥2-point Improvement from Baseline [ Time Frame: Week 24, 36 ]

Description

EB hair loss 0 or 1 with ≥2-point Improvement from Baseline

Time Frame

Week 24, 36

Title

Measure for Eyelash (EL) Hair Loss 0 or 1 with ≥2-point Improvement from Baseline

Description

EL hair loss 0 or 1 with ≥2-point Improvement from Baseline

Time Frame

Week 24, 36

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female subjects with the age of ≥18 and ≤ 65 years old at the time of informed consent. Able to understand the procedures and methods of this study, and will to provide a signed and dated informed consent form. Diagnosed alopecia areata(AA) without other reasons caused alopecia. 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. 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: Known history of anaphylaxis to any of the ingredients and/or other similar products. 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. Previously treated with JAK inhibitors. Corticosteroids, finasteride, minoxidil,topical immunotherapy treated within 8 weeks before randomization. Diphenylcyclopropenone (DPCP), HMGCoA reductase inhibitor, Chinese herbal medicine treated within 4 weeks before randomization. With other diseases: acute "diffuse" type of AA, lymphoproliferative disease, tumor, severe chronic gastrointestinal disease, thyroid disorders, serious cardiovascular disease. 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. 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. Subjects who are unsuitable to the trial, as identified by the investigator.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Xiaoli Cai

Phone

021-60718153

caixl@kelun.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xingqi Zhang

Organizational Affiliation

First Affiliated Hospital, Sun Yat-Sen University

Official's Role

Principal Investigator

Facility Information:

Facility Name

The First Affiliated Hospital of Sun Yat-sen University

City

Guangzhou

State/Province

Guangzhou

ZIP/Postal Code

510080

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

A Study of KL130008 in Adults With Severe Alopecia Areata

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