A Phase 3 Study to Evaluate the Safety and Efficacy of CKD-843 in Male Patients With Androgenetic Alopecia
NCT ID: NCT06916793
Last Updated: 2025-04-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
288 participants
INTERVENTIONAL
2025-04-30
2027-09-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Test Group1
CKD-843 dose#1 + Placebo of Dutasteride Capsule
CKD-843 dose#1
IM injection every 3 months for 12 months
Placebo of Dutasteride Capsule
oral, once daily, 12 months
Test Group2
CKD-843 dose#2 + Placebo of Dutasteride Capsule
CKD-843 dose#2
IM injection every 3 months for 12 months
Placebo of Dutasteride Capsule
oral, once daily, 12 months
Placebo-controlled Group
Placebo of CKD-843 dose + Placebo of Dutasteride Capsule
Placebo of CKD-843 dose
IM injection every 3 months for 12 months
Placebo of Dutasteride Capsule
oral, once daily, 12 months
Active-controlled Group
Placebo of CKD-843 dose + Dutasteride Capsules
Placebo of CKD-843 dose
IM injection every 3 months for 12 months
Dutasteride Capsules
oral, once daily, 12 months
Interventions
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CKD-843 dose#1
IM injection every 3 months for 12 months
CKD-843 dose#2
IM injection every 3 months for 12 months
Placebo of CKD-843 dose
IM injection every 3 months for 12 months
Dutasteride Capsules
oral, once daily, 12 months
Placebo of Dutasteride Capsule
oral, once daily, 12 months
Eligibility Criteria
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Inclusion Criteria
* Clinical Diagnosis of Androgenetic Alopecia
* Written informed consent
Exclusion Criteria
* Clinically significant scalp disease such as seborrheic dermatitis or psoriasis
* Clinically significant hepatic disease, thyroid disease, or mental illness, as determined by the Investigator
* Participants who do not agree to use contraception during the trial and for 24 weeks after the last dose, and plan to provide sperm or conceive within 24 weeks after the last dose
18 Years
50 Years
MALE
No
Sponsors
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Chong Kun Dang Pharmaceutical
INDUSTRY
Responsible Party
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Principal Investigators
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OhSang Kwon, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Locations
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Seoul National University Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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A107_03AGA2318
Identifier Type: -
Identifier Source: org_study_id
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