Androgenetic Alopecia (AGA)Phase 2/3NCT06622824
To Evaluate Efficacy and Safety of TopicalKX-826 Solution in Chinese Male Patients With Androgenetic Alopecia
A Phase 2/3 study testing KX-826 0.5% BID and KX-826 1.0% BID in people with Androgenetic Alopecia (AGA), run by Suzhou Kintor Pharmaceutical Inc, at 1 site in China.
Trial summary
This study is a multicenter, randomized, double-blind, vehicle controlled, adaptive design phase 2/3 study to evaluate the efficacy and safety of topical KX-826 solution in Chinese male patients with androgenetic alopecia (AGA). It consisted of two phases, phase 2 dose exploration trial and phase 3 confirmatory trial. Read more about this study
- Who is it for?
- Ages 18 to 49 years, men only
- Conditions the study is for
- Androgenetic Alopecia (AGA)
- What is being tested?
- KX-826 0.5% BID and KX-826 1.0% BID
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 756 participants
- Where
- 1 siteChina
- Study dates
- 15 Oct 2024to 30 Jun 2028
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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 49 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Agree to comply with study procedures and visit plan. Subject is capable of giving informed consent;
- Male between the ages of 18 and 49 years, inclusive;
- Clinically diagnosed as androgenetic alopecia;
- Rating IIIv, IV and V on the Norwood Hamilton Scale; subject is willing to receive a ink dot tattoo;
- Subject is willing to maintain the same hairstyle, hair length, and hair color at each visit;
- Willing to use highly effective contraceptive measures during the study period and 3 months after the last dose.
Who cannot join
- Had a history or active hair loss due to diffuse telogen effluvium, alopecia areata, scarring alopecia, trichotillomania, or conditions/diseases other than AGA;
- Had gray hair in the target alopecia area;
- Had too short hair that, in the investogator's opinion, might affect hair growth assessment;
- Had any skin pathology or condition that, in the investigator's opinion, could interfere with the evaluation of the investigational drug (e.g., fungal or bacterial infection, severe seborrheic dermatitis, solar keratosis, scalp psoriasis, contact dermatitis, severe folliculitis or scalp atrophy);
- Had a significant increase in hair loss determined by investigator within 6 months prior to screening;
- Had scalp hair transplants or hair extension history; need of wearing wig for a long time during the study;
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- Subjects who plan to use any adjuvant or concomitant therapy for the treatment of alopecia throughout the study;
- Subjects with a previous or current diagnosis of hyperthyroidism or hypothyroidism;
- Subjects with diseases that affect hair growth, such as connective tissue disease, inflammatory bowel disease, moderate to severe anemia, and significant short-term weight loss;
- Had used finasteride or dutasteride prior to screening;
- Had used platelet rich plasma (PRP) procedure within 12 months prior to screening;
- Had used scalp surgical procedure within 12 months prior to screening; Had used laser, light, or energy treatments within 6 months of screening;
- Had used anti-androgenic drugs (e.g., flutamide, cyproterone, drospirosterone, estrogen, progesterone, cimetidine, spironolactone, or oral ketoconazole, etc) within 6 months prior to screening;
- Had used the following medications that may affect the evaluation of efficacy in the study within 6 months prior to screening:
- Oral or topical minoxidil
- Systemic interferon
- Immunosuppressants such as cyclosporine
- Diuretics
- Beta-blockers (e.g., propranolol, atenolol, metoprolol, etc)
- Anticoagulants (e.g., warfarin, heparin, heparin analogues, etc)
- Anti-thyroid drugs (e.g., thiouracil, methiimidazole, etc)
- Antipsychotic drugs (e.g., valproic acid, carbamazepine, phenytoin sodium, phenothiazines, fluoxetine, etc)
- Anti-retroviral drugs (e.g., zidovudine, indonavir, ritonavir, lopinavir, etc)
- Retinoids (e.g., actinoic acid, isotretinoic acid, etc), or use vitamin A supplements or A daily dietary intake of more than 10,000 IU of vitamin A
- Used systemic steroids for more than 14 consecutive days within 3 months prior to screening;
- Used oral hair growth supplements or herbs within 3 months prior to screening;
- Use of hair growth shampoo such as ketoconazole or solution within 1 month prior to screening;
- Subjects with acute infection of novel coronavirus and receiving (attenuated) live vaccine within 1 month prior to screening;
- Abnormal and clinically significant findings in physical examination, vital signs, 12-lead ECG, hematology, urinalysis, blood chemistry, and thyroid function test at screening, which will affect the efficacy and safety evaluation and study results as judged by the investigator;
- Positive blood screen for human immunodeficiency virus(HIV), hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or treponema pallidum antibody;
- Have treated with KX-826 or GT20029 previously;
- Subjects with sleep disorders, as assessed by the investigator, that affect hair growth, or the efficacy evaluation;
- Subjects with depression, anxiety, or personality disorders, as assessed by the investigator, that affect hair growth, or the efficacy evaluation;
- Has a known hypersensitivity or previous allergic reaction to any of the active or inactive ingredients in the investigational drug;
- Medical/surgical history of any uncontrolled systemic disease that is serious or may affect the safety and efficacy evaluation of the investigational product, such as cardiovascular system, nervous system, hematological system, immune system, and psychiatric system disease;
- Have undergone major surgery within 6 months prior to screening, or plan to undergo major surgery during the study;
- Had a history of malignancy (except for cured carcinoma in situ) within 5 years prior to screening;
- Subjects who have participated or are participating clinical studies of interventional drugs or medical devices within 3 months prior to screening;
- Had a history of drug abuse within 12 months prior to screening;
- Subjects who consumed large amounts of tea/coffee within 3 months prior to screening, as assessed by the investigator, that may affect hair growth, or the efficacy evaluation;
- Subjects who, in the opinion of the investigator, have other conditions that may affect compliance or are not suitable for participation in this study;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Peking University People's Hospital
Beijing
Xiaoyan Ni, +86 15050402391, xyni@kintor.com.cn
JianZhong Zhang
About this study
Official title: Efficacy and Safety of Topical KX-826 Solution in Chinese Male Patients With Androgenetic Alopecia: A Multicenter, Randomized, Double-blind, Vehicle Controlled Adaptive Design Phase 2/3 Study
This study is a multicenter, randomized, double-blind, vehicle controlled, adaptive design phase 2/3 study to evaluate the efficacy and safety of topical KX-826 solution in Chinese male patients with androgenetic alopecia (AGA). It consisted of two phases, phase 2 dose exploration trial and phase 3 confirmatory trial.
Read the detailed description
In phase 2 study, around 90 adult male subjects with AGA (rating IIIv, IV and V on Hamilton-Norwood scale) were to be enrolled. All subjects would be evaluated with 1:1:1 randomized to receive KX-826 0.5% BID, KX-826 1.0% BID and vehicle in a double-blind fashion (30 subjects in each group), and would be treated for 24 weeks at the specified dose. During the study, the subjects would undergo periodic efficacy and safety-related examinations and evaluation. A Phase 2 statistical analysis will be performed when 90 patients complete the Week 24 visit or early withdrawal visit.
Blood samples will be collected at the following time points:
Day 1: 3 hours (pre-dose) W6 (Day 42): 3 hours (pre-dose) W12 (Day 84): 3 hours (pre-dose)
In phase 3 study, around 666 adult male subjects with AGA (rating IIIv, IV and V on Hamilton-Norwood scale) were to be enrolled. All subjects would be evaluated with 1:1:1 randomized to receive KX-826 0.5% BID, KX-826 1.0% BID and vehicle in a double-blind fashion (222 subjects in each group), and would be treated for 24 weeks at the specified dose. During the study, the subjects would undergo periodic efficacy and safety-related examinations and evaluation.
- Conditions
- Androgenetic Alopecia (AGA)
- Being tested
- KX-826 0.5% BID, KX-826 1.0% BID, Vehicle (Placebo) applied BID
- Keywords
- androgenetic alopecia, Hair loss
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KX-826 0.5% BIDDrug
0.5% of the investigational drug KX-826 to be applied topically to scalp twice daily for 24 weeks
KX-826 1.0% BIDDrug
1.0% of the investigational drug KX-826 to be applied topically to scalp twice daily for 24 weeks
Vehicle (Placebo) applied BIDDrug
Matching placebo applied topically to scalp twice daily for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | KX-826 0.5% BID Receives: Drug: KX-826 0.5% BID |
| Arm B | Experimental | KX-826 1.0% BID Receives: Drug: KX-826 1.0% BID |
| Arm C | Placebo comparator | Matching Vehicle Receives: Drug: Vehicle (Placebo) applied BID |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target Area Non-vellus Hair count (TAHC) change from baseline at week 24 in comparison to vehicle.
Changes from baseline in non-vellus TAHC (Target Area Hair Counts) in comparison to vehicle (Non-vellus TAHC is the number of non-vellus hairs within 1 cm² scalp, which usually ranges from 0 to 300. Larger non-vellus TAHC implies thicker hair. In this study, larger change in non-vellus TAHC means better outcome.)
Measured: 24 weeks
Secondary outcomes (4)
Hair Growth Assessment (HGA)
Changes from baseline HGA (Hair Growth Assessment) score by Principal Investigator and subjects (HGA scale ranged from -3 to 3 and represented decreases from baseline that were substantial, moderate, slight, no change, slight increases, moderate increases, and substantial increases, respectively. HGA improvement was defined as a hair growth assessment score of larger than 0.)
Measured: 6 weeks, 12 weeks, 18 weeks and 24 weeks
Target Area Non-vellus Hair diameter (TAHW) assessment
Target Area Non-vellus Hair diameter (TAHW) change from baseline at week 6, 12, 18, and 24 in comparison to vehicle
Measured: 6 weeks, 12 weeks, 18 weeks and 24 weeks
Target Area total hair counts
Target Area total hair counts change from baseline at week 6, 12, 18, and 24 in comparison to vehicle
Measured: 6 weeks, 12 weeks, 18 weeks and 24 weeks
TAHC assessment
Changes from baseline in non-vellus TAHC (Target Area Hair Counts) in comparison to vehicle (Non-vellus TAHC is the number of non-vellus hairs within 1 cm² scalp, which usually ranges from 0 to 300. Larger non-vellus TAHC implies thicker hair. In this study, larger change in non-vellus TAHC means better outcome.)
Measured: 6 weeks, 12 weeks, 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2024
- Study start15 Oct 2024 (estimated)
- Primary completion20 Oct 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Androgenetic Alopecia (AGA)Studies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 756 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suzhou Kintor Pharmaceutical Inc,
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Suzhou Koshine Biomedica, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06622824
- Sponsor's protocol ID
- KX0826-CN-1010
- Status last verified
- Sep 2024
- First submitted
- 29 Sep 2024
- Last updated
- 21 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 21 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Topical KX-826 Solution in Chinese Male Patients With Androgenetic Alopecia: A Multicenter, Randomized, Double-blind, Vehicle Controlled Adaptive Design Phase 2/3 Study
- ClinicalTrials.gov ID
- NCT06622824
- Acronym / sponsor ID
- KX0826-CN-1010
- Conditions
- Androgenetic Alopecia (AGA)
- Keywords
- androgenetic alopecia, Hair loss
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 756 participants (estimated)
- Lead sponsor
- Suzhou Kintor Pharmaceutical Inc,Industry (pharma, biotech, devices)
- Collaborators
- Suzhou Koshine Biomedica, Inc.
- Study start
- 15 Oct 2024 (estimated)
- Primary completion
- 20 Oct 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 2 Oct 2024 (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.
This study is a multicenter, randomized, double-blind, vehicle controlled, adaptive design phase 2/3 study to evaluate the efficacy and safety of topical KX-826 solution in Chinese male patients with androgenetic alopecia (AGA). It consisted of two phases, phase 2 dose exploration trial and phase 3 confirmatory trial.
Detailed description
In phase 2 study, around 90 adult male subjects with AGA (rating IIIv, IV and V on Hamilton-Norwood scale) were to be enrolled. All subjects would be evaluated with 1:1:1 randomized to receive KX-826 0.5% BID, KX-826 1.0% BID and vehicle in a double-blind fashion (30 subjects in each group), and would be treated for 24 weeks at the specified dose. During the study, the subjects would undergo periodic efficacy and safety-related examinations and evaluation. A Phase 2 statistical analysis will be performed when 90 patients complete the Week 24 visit or early withdrawal visit.
Blood samples will be collected at the following time points:
Day 1: 3 hours (pre-dose) W6 (Day 42): 3 hours (pre-dose) W12 (Day 84): 3 hours (pre-dose)
In phase 3 study, around 666 adult male subjects with AGA (rating IIIv, IV and V on Hamilton-Norwood scale) were to be enrolled. All subjects would be evaluated with 1:1:1 randomized to receive KX-826 0.5% BID, KX-826 1.0% BID and vehicle in a double-blind fashion (222 subjects in each group), and would be treated for 24 weeks at the specified dose. During the study, the subjects would undergo periodic efficacy and safety-related examinations and evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: KX-826 0.5% BIDKX-826 0.5% BID |
| Arm B | Experimental | Drug: KX-826 1.0% BIDKX-826 1.0% BID |
| Arm C | Placebo comparator | Drug: Vehicle (Placebo) applied BIDMatching Vehicle |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Agree to comply with study procedures and visit plan. Subject is capable of giving informed consent;
- Male between the ages of 18 and 49 years, inclusive;
- Clinically diagnosed as androgenetic alopecia;
- Rating IIIv, IV and V on the Norwood Hamilton Scale; subject is willing to receive a ink dot tattoo;
- Subject is willing to maintain the same hairstyle, hair length, and hair color at each visit;
Key exclusion criteria (41 listed)
- Had a history or active hair loss due to diffuse telogen effluvium, alopecia areata, scarring alopecia, trichotillomania, or conditions/diseases other than AGA;
- Had gray hair in the target alopecia area;
- Had too short hair that, in the investogator's opinion, might affect hair growth assessment;
- Had any skin pathology or condition that, in the investigator's opinion, could interfere with the evaluation of the investigational drug (e.g., fungal or bacterial infection, severe seborrheic dermatitis, solar keratosis, scalp psoriasis, contact dermatitis, severe folliculitis or scalp atrophy);
- Had a significant increase in hair loss determined by investigator within 6 months prior to screening;
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 |
|---|---|---|
| KX-826 0.5% BID0.5% of the investigational drug KX-826 to be applied topically to scalp twice daily for 24 weeks | Drug | Arm A |
| KX-826 1.0% BID1.0% of the investigational drug KX-826 to be applied topically to scalp twice daily for 24 weeks | Drug | Arm B |
| Vehicle (Placebo) applied BIDMatching placebo applied topically to scalp twice daily for 24 weeks | Drug | Arm C |
Primary outcome
Target Area Non-vellus Hair count (TAHC) change from baseline at week 24 in comparison to vehicle.
Time frame: 24 weeks
Changes from baseline in non-vellus TAHC (Target Area Hair Counts) in comparison to vehicle (Non-vellus TAHC is the number of non-vellus hairs within 1 cm² scalp, which usually ranges from 0 to 300. Larger non-vellus TAHC implies thicker hair. In this study, larger change in non-vellus TAHC means better outcome.)
4 secondary outcomes
Hair Growth Assessment (HGA)
Time frame: 6 weeks, 12 weeks, 18 weeks and 24 weeks
Target Area Non-vellus Hair diameter (TAHW) assessment
Time frame: 6 weeks, 12 weeks, 18 weeks and 24 weeks
Target Area total hair counts
Time frame: 6 weeks, 12 weeks, 18 weeks and 24 weeks
TAHC assessment
Time frame: 6 weeks, 12 weeks, 18 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing KX-826 0.5% BID and KX-826 1.0% BID in people with Androgenetic Alopecia (AGA), run by Suzhou Kintor Pharmaceutical Inc, 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 6 inclusion and 41 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: opening soon, as of the sponsor's last update on 21 Oct 2024. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaoyan Ni (+86 15050402391, xyni@kintor.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target Area Non-vellus Hair count (TAHC) change from baseline at week 24 in comparison to vehicle. (time frame: 24 weeks). 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 21 Oct 2024.