AlopeciaPhase 2NCT05218642
To Evaluate Efficacy, Safety, and Tolerability of KX-826 in Male Subjects With Androgenetic Alopecia
A Phase 2 study testing KX- 826 dosed at 2.5mg and KX-826 dosed at 5mg in people with Alopecia and Male Pattern Hair Loss, run by Suzhou Kintor Pharmaceutical Inc, at 10 sites in United States.
Trial summary
The study is a randomized, double-blind, placebo-controlled, parallel group, phase 2 study to evaluate the efficacy, safety and tolerability of KX-826 in male subjects with androgenetic alopecia. Read more about this study
- Who is it for?
- Ages 18 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Alopecia, Male Pattern Hair Loss
- What is being tested?
- KX- 826 dosed at 2.5mg and KX-826 dosed at 5mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 123 participants
- Where
- 10 sitesUnited States
- Study dates
- 31 Jan 2022to 13 Feb 2023
- 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 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject is capable of giving informed consent and complying with study procedures;
- Subject is male between the ages of 18 and 70 years, inclusive;
- Subject has a clinical diagnosis of mild to moderate androgenetic alopecia; rating IIIv, IV and V on the Norwood Hamilton Scale, with a history of ongoing hair loss;
- Subject is willing to maintain the same hairstyle, hair length, and hair color throughout the study
- Subject agrees to continue his other general hair care products and regimen for the entire study;
- Subject is considered healthy by the Principal Investigator, based on a detailed medical history, full physical examination, clinical laboratory tests, 12-lead ECG and vital signs (systolic blood pressure ≥90 and
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- ≤150 mmHg, diastolic blood pressure ≥50 and ≤95 mmHg and pulse rate
- ≥45 and ≤100 bpm; one repeat of results is allowed to evaluate out of range values);
- Negative COVID-19 results within 3 days prior first dosing
Who cannot join
- Subject has any dermatological disorders of the scalp in the target region with the possibility of interfering with the application of the investigational drug, such as fungal or bacterial infections, seborrheic dermatitis, psoriasis, eczema, folliculitis, scars, or scalp atrophy;
- Subject has any skin pathology or condition that, in the investigator's opinion, could interfere with the evaluation of the investigational drug or requires use of interfering topical, systemic (e.g., uncontrolled thyroid disease, certain genetic disorders that involve hair growth or patterns), or surgical therapy;
- Subject has current or recent history (within 12 months) of hair weaves, non-breathable wigs, or hair bonding;
- Subject had scalp hair transplants at any time
- Subject has a history or active hair loss due to diffuse telogen effluvium, alopecia areata, scarring alopecia, trichotillomania, or conditions/ diseases other than AGA;
- Subject has a current or recent history (within six months) of severe dietary or weight changes or has a history of eating disorder(s); if such has resulted in hair loss;
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- Any disorder, including but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric, or major physical impairment that is not stable in the opinion of the Investigator and could:
- Affect the safety of the subject throughout the study
- Influence the findings of the studies or their interpretations
- Impede the subject's ability to complete the entire duration of study
- Subject is currently enrolled in an investigational drug or device study;
- Subject has used an investigational drug or investigational device treatment within 30 days prior to randomization;
- Subject is unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function;
- Subject may be unreliable for the study including subjects who engage in excessive alcohol intake or drug abuse (defined as any illicit drug use), or subjects who are unable to return for scheduled follow-up visits;
- Positive blood screen for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibody;
- Subject has a known hypersensitivity or previous allergic reaction to any of the active or inactive ingredients in the investigational drug or tattoo ink.
- Subject has used any of the following topical preparations or procedures on the scalp:
- Topical scalp treatments for hair growth including minoxidil, hormone therapy, anti-androgens, or other agents that are known to affect hair growth within 12 weeks of randomization;
- Use of hair regrowth products, including minoxidil, for >4 continuous weeks within 6 months before randomization;
- Medical shampoos or solutions which include Ketoconazole or the like (e.g. Terzolin) within four weeks prior to randomization;
- Topical scalp over-the-counter (OTC) or cosmetic treatments known or reasonably believed to affect hair growth (e.g., brands such as Aminexil, Maxilene, Nioxin, Foltene, etc.) or hair health or hair growth products with saw palmetto, copper, etc. within four weeks of randomization;
- Topical scalp treatments that may have ancillary effect on hair growth including, but not limited to, corticosteroids, pimecrolimus, tacrolimus, and retinoids within four weeks of randomization;
- Scalp procedures (surgical, laser, light, or energy treatments, microneedling, etc.) within six months of randomization;
- Platelet rich plasma (PRP) procedure on the scalp at any time point.
- Subject has used the following systemic medications or procedures:
- Beta blockers, cimetidine, diazoxide, or corticosteroids (including intramuscular and intralesional injections) within 12 weeks of randomization. Inhaled, intranasal, or ocular corticosteroids are allowed if use is stable [defined as doses and frequency unchanged for at least four weeks prior to randomization];
- Retinoid, isotretinoin, vitamin A intake above 10,000 IU per day, or cyclosporine therapy within six months of randomization;
- Use of immunoglobulins/immunomodulators (eg, cyclosporin) for >4 continuous weeks within 6 months of randomization,
- Use of 5-α-reductase inhibitors (eg, finasteride or dutasteride) and/ or antiandrogens within 12 months before randomization;
- Use of systemic cimetidine or ketoconazole for >2 continuous weeks within 3 months before randomization;
- Chemotherapy or cytotoxic agents within 12 months of randomization;
- Radiation of the scalp at any time point;
- Use of systemic corticosteroids within 2 months of randomization for >2 consecutive weeks,
- Other systemic therapy, which in the opinion of the investigator, may materially affect the subject's hair or hair growth, including, but not limited to, vitamin or homeopathy supplement hair growth or hair health products or other steroid hormones (in any form), including anabolic steroids;
- An unwillingness of male participants to use highly effective contraceptive measures if engaging in sexual intercourse with a female partner of childbearing potential. Highly effective measures include use of a condom and spermicide and, for female partners, use of an intrauterine device (IUD), diaphragm with spermicide, oral contraceptives, injectable progesterone, progesterone subdermal implants, or a tubal ligation.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
DelRicht Research
Baton Rouge, Louisiana, 70808
ALLCUTIS Research, LLC
Beverly, Massachusetts, 01915
First OC Dermatology
Fountain Valley, California, 92708
Qway Research LLC
Hialeah, Florida, 33010
Evoution Clinical Trials
Hialeah Gardens, Florida, 33016
Anchor Medical Research, LLC
Miami, Florida, 33176
Innovation Medical Group, LLC
Palmetto Bay, Florida, 33157
ALLCUTIS Research, LLC
Portsmouth, New Hampshire, 03801
Clinical Trials of Texas, LLC
San Antonio, Texas, 78229
Palm Beach Research Center
West Palm Beach, Florida, 33409
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 2 Study in Male Subjects With Androgenetic Alopecia to Evaluate the Efficacy, Safety, and Tolerability of KX-826 Following Topical Multiple Dose Administration
The study is a randomized, double-blind, placebo-controlled, parallel group, phase 2 study to evaluate the efficacy, safety and tolerability of KX-826 in male subjects with androgenetic alopecia.
Read the detailed description
KX-826 is a new investigational androgen receptor (AR) antagonist for the treatment of male pattern hair loss (androgenetic alopecia). A total of 120 subjects will be randomized to one of four cohorts: 2.5 mg BID, 5 mg QD, 5mg BID of KX-826 or placebo (BID or QD) for 24 weeks. The primary endpoint of the study is to assess the changes from baseline in non-vellus TAHC （Target Area Hair Counts）at Week 24 in comparison to placebo
- Conditions
- Alopecia, Male Pattern Hair Loss
- Being tested
- KX- 826 dosed at 2.5mg, KX-826 dosed at 5mg, Matching placebo to KX-826
- Keywords
- Androgenetic Alopecia, Hair loss, Hair thinning, Baldness
- 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 dosed at 2.5mgDrug
2.5mg of the investigational drug to be applied topically to scalp twice daily for 24 weeks
KX-826 dosed at 5mgDrug
5mg of the investigational drug to be applied topically to scalp once daily for 24 weeks
KX-826 dosed at 5mgDrug
5mg of the investigational drug to be applied topically to scalp twice daily for 24 weeks
Matching placebo to KX-826Drug
Placebo applied topically to scalp twice daily or once daily for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | KX-826: 2.5mg twice daily Receives: Drug: KX- 826 dosed at 2.5mg |
| Arm B | Experimental | KX-826: 5mg once daily Receives: Drug: KX-826 dosed at 5mg |
| Arm C | Experimental | KX-826: 5mg twice daily Receives: Drug: KX-826 dosed at 5mg |
| Arm D | Experimental | Matching placebo to KX-826 Receives: Drug: Matching placebo to KX-826 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of change in Target Area Hair Counts
Changes from baseline in non-vellus TAHC (Target Area Hair Counts) in comparison to placebo
Measured: 24 weeks
Secondary outcomes (1)
Assessment of change in Hair Growth Assessment score
Changes from baseline in HGA (Hair Growth Assessment) score by Principal Investigator, subjects, and Canfield Independent panel review in comparison to placebo
Measured: 6,12,18 and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2022
- Study start31 Jan 2022
- Primary completion13 Feb 2023
- Study completion13 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AlopeciaStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Assignment
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suzhou Kintor Pharmaceutical Inc,
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05218642
- Sponsor's protocol ID
- KX0826-US-1003
- Status last verified
- Jun 2023
- First submitted
- 30 Jan 2022
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 2 Study in Male Subjects With Androgenetic Alopecia to Evaluate the Efficacy, Safety, and Tolerability of KX-826 Following Topical Multiple Dose Administration
- ClinicalTrials.gov ID
- NCT05218642
- Acronym / sponsor ID
- KX0826-US-1003
- Conditions
- Alopecia, Male Pattern Hair Loss
- Keywords
- Androgenetic Alopecia, Hair loss, Hair thinning, Baldness
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Suzhou Kintor Pharmaceutical Inc,Industry (pharma, biotech, devices)
- Study start
- 31 Jan 2022 (actual)
- Primary completion
- 13 Feb 2023 (actual)
- Study completion
- 13 Feb 2023 (actual)
- First posted
- 1 Feb 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 study is a randomized, double-blind, placebo-controlled, parallel group, phase 2 study to evaluate the efficacy, safety and tolerability of KX-826 in male subjects with androgenetic alopecia.
Detailed description
KX-826 is a new investigational androgen receptor (AR) antagonist for the treatment of male pattern hair loss (androgenetic alopecia). A total of 120 subjects will be randomized to one of four cohorts: 2.5 mg BID, 5 mg QD, 5mg BID of KX-826 or placebo (BID or QD) for 24 weeks. The primary endpoint of the study is to assess the changes from baseline in non-vellus TAHC （Target Area Hair Counts）at Week 24 in comparison to placebo
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Assignment
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: KX- 826 dosed at 2.5mgKX-826: 2.5mg twice daily |
| Arm B | Experimental | Drug: KX-826 dosed at 5mgKX-826: 5mg once daily |
| Arm C | Experimental | Drug: KX-826 dosed at 5mgKX-826: 5mg twice daily |
| Arm D | Experimental | Drug: Matching placebo to KX-826Matching placebo to KX-826 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subject is capable of giving informed consent and complying with study procedures;
- Subject is male between the ages of 18 and 70 years, inclusive;
- Subject has a clinical diagnosis of mild to moderate androgenetic alopecia; rating IIIv, IV and V on the Norwood Hamilton Scale, with a history of ongoing hair loss;
- Subject is willing to maintain the same hairstyle, hair length, and hair color throughout the study
- Subject agrees to continue his other general hair care products and regimen for the entire study;
Key exclusion criteria (35 listed)
- Subject has any dermatological disorders of the scalp in the target region with the possibility of interfering with the application of the investigational drug, such as fungal or bacterial infections, seborrheic dermatitis, psoriasis, eczema, folliculitis, scars, or scalp atrophy;
- Subject has any skin pathology or condition that, in the investigator's opinion, could interfere with the evaluation of the investigational drug or requires use of interfering topical, systemic (e.g., uncontrolled thyroid disease, certain genetic disorders that involve hair growth or patterns), or surgical therapy;
- Subject has current or recent history (within 12 months) of hair weaves, non-breathable wigs, or hair bonding;
- Subject had scalp hair transplants at any time
- Subject has a history or active hair loss due to diffuse telogen effluvium, alopecia areata, scarring alopecia, trichotillomania, or conditions/ diseases other than AGA;
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 dosed at 2.5mg2.5mg of the investigational drug to be applied topically to scalp twice daily for 24 weeks | Drug | Arm A |
| KX-826 dosed at 5mg5mg of the investigational drug to be applied topically to scalp once daily for 24 weeks | Drug | Arm B |
| KX-826 dosed at 5mg5mg of the investigational drug to be applied topically to scalp twice daily for 24 weeks | Drug | Arm C |
| Matching placebo to KX-826Placebo applied topically to scalp twice daily or once daily for 24 weeks | Drug | Arm D |
Primary outcome
Assessment of change in Target Area Hair Counts
Time frame: 24 weeks
Changes from baseline in non-vellus TAHC (Target Area Hair Counts) in comparison to placebo
1 secondary outcome
Assessment of change in Hair Growth Assessment score
Time frame: 6,12,18 and 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing KX- 826 dosed at 2.5mg and KX-826 dosed at 5mg in people with Alopecia and Male Pattern Hair Loss, run by Suzhou Kintor Pharmaceutical Inc, at 10 sites in United States.
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 9 inclusion and 35 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: finished, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Assessment of change in Target Area Hair Counts (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 22 Nov 2023.