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
Sponsored by
About this trial
This is an interventional treatment trial for Alopecia Areata focused on measuring Alopecia Areata, Hypotrichosis, Hair Diseases
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.
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
Experimental
Experimental
Placebo Comparator
Arm Label
KL130008 capsule High Dose
KL130008 capsule Middle Dose
KL130008 capsule Low Dose
Placebo
Arm Description
KL130008 capsule administered orally
KL130008 capsule administered orally
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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
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
No
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
Email
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
No
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A Study of KL130008 in Adults With Severe Alopecia Areata
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