Alopecia AreataPhase 2NCT05496426
A Study of KL130008 in Adults With Severe Alopecia Areata
A Phase 2 study of Alopecia Areata, run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study is to assess KL130008 is safe and effective in adults with severe alopecia areata Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Alopecia Areata
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 114 participants
- Where
- 1 siteChina
- Study dates
- 9 Nov 2022to 16 Apr 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangzhou, 510080
About this study
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
The purpose of this study is to assess KL130008 is safe and effective in adults with severe alopecia areata
Read the 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
- Being tested
- KL130008/Placebo
- Keywords
- Alopecia Areata, Hypotrichosis, Hair Diseases
- Medical subject headings
- Alopecia Areata, Hypotrichosis, Hair Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KL130008/PlaceboDrug
Drug: KL130008 Drug: Placebo
| Study group | Role | What they receive |
|---|---|---|
| KL130008 capsule High Dose | Experimental | KL130008 capsule administered orally Receives: Drug: KL130008/Placebo |
| KL130008 capsule Middle Dose | Experimental | KL130008 capsule administered orally Receives: Drug: KL130008/Placebo |
| KL130008 capsule Low Dose | Experimental | KL130008 capsule administered orally Receives: Drug: KL130008/Placebo |
| Placebo | Placebo comparator | Placebo administered orally Receives: Drug: KL130008/Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Achieving Severity of Alopecia Tool (SALT) ≤ 20 [ Time Frame: Week 24 ]
Percentage of Participants Achieving SALT ≤ 20
Measured: Week 24
Secondary outcomes (7)
Percentage of Participants Achieving Severity of Alopecia Tool (SALT) ≤ 20 [ Time Frame: Week 36 ]
Percentage of Participants Achieving SALT ≤ 20
Measured: Week 36
Percent Change from Baseline in SALT score [ Time Frame: Baseline, Week 24, 36 ]
Percent change from baseline in SALT score
Measured: Week 24, 36
Percentage of Participants Achieving 50% Improvement of Severity of Alopecia Tool (SALT50) [ Time Frame: Week 24, 36 ]
Percentage of participants achieving SALT50
Measured: Week 24, 36
Percentage of Participants Achieving 75% Improvement of Severity of Alopecia Tool (SALT50) [ Time Frame: Week 24, 36 ]
Percentage of participants achieving SALT75
Measured: Week 24, 36
Percentage of Participants Achieving Severity of Alopecia Tool (SALT) ≤ 10 [ Time Frame: Week 24, 36 ]
Percentage of Participants Achieving SALT ≤ 10
Measured: Week 24, 36
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
Measured: Week 24, 36
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
Measured: Week 24, 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2022
- Study start9 Nov 2022
- Primary completion16 Apr 2024
- Study completion16 Apr 2024
Why it stopped: This adjustment to the company's development strategy is unrelated to safety or efficacy.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alopecia AreataStudies of the same condition, open and under way.
- More trials run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xingqi Zhang, Principal investigator, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05496426
- Sponsor's protocol ID
- KL223-II-05
- Other IDs
- CTR20221881
- Status last verified
- May 2026
- First submitted
- 9 Aug 2022
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05496426
- Acronym / sponsor ID
- KL223-II-05
- Conditions
- Alopecia Areata
- Keywords
- Alopecia Areata, Hypotrichosis, Hair Diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This adjustment to the company's development strategy is unrelated to safety or efficacy.
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Nov 2022 (actual)
- Primary completion
- 16 Apr 2024 (actual)
- Study completion
- 16 Apr 2024 (actual)
- First posted
- 11 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| KL130008 capsule High Dose | Experimental | Drug: KL130008/PlaceboKL130008 capsule administered orally |
| KL130008 capsule Middle Dose | Experimental | Drug: KL130008/PlaceboKL130008 capsule administered orally |
| KL130008 capsule Low Dose | Experimental | Drug: KL130008/PlaceboKL130008 capsule administered orally |
| Placebo | Placebo comparator | Drug: KL130008/PlaceboPlacebo administered orally |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KL130008/PlaceboDrug: KL130008 Drug: Placebo | Drug | KL130008 capsule High Dose, KL130008 capsule Low Dose, KL130008 capsule Middle Dose, Placebo |
Primary outcome
Percentage of Participants Achieving Severity of Alopecia Tool (SALT) ≤ 20 [ Time Frame: Week 24 ]
Time frame: Week 24
Percentage of Participants Achieving SALT ≤ 20
7 secondary outcomes
Percentage of Participants Achieving Severity of Alopecia Tool (SALT) ≤ 20 [ Time Frame: Week 36 ]
Time frame: Week 36
Percent Change from Baseline in SALT score [ Time Frame: Baseline, Week 24, 36 ]
Time frame: Week 24, 36
Percentage of Participants Achieving 50% Improvement of Severity of Alopecia Tool (SALT50) [ Time Frame: Week 24, 36 ]
Time frame: Week 24, 36
Percentage of Participants Achieving 75% Improvement of Severity of Alopecia Tool (SALT50) [ Time Frame: Week 24, 36 ]
Time frame: Week 24, 36
Percentage of Participants Achieving Severity of Alopecia Tool (SALT) ≤ 10 [ Time Frame: Week 24, 36 ]
Time frame: Week 24, 36
Measure for Eyebrow (EB) Hair Loss 0 or 1 with ≥2-point Improvement from Baseline [ Time Frame: Week 24, 36 ]
Time frame: Week 24, 36
Measure for Eyelash (EL) Hair Loss 0 or 1 with ≥2-point Improvement from Baseline
Time frame: Week 24, 36
Results and safety
The study was stopped early (reason given: This adjustment to the company's development strategy is unrelated to safety or efficacy.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xingqi Zhang principal investigator
First Affiliated Hospital, Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study of Alopecia Areata, run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: This adjustment to the company's development strategy is unrelated to safety or efficacy.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Achieving Severity of Alopecia Tool (SALT) ≤ 20 [ Time Frame: Week 24 ] (time frame: Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.