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

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

288 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-30

Study Completion Date

2027-09-17

Brief Summary

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This is a multi-centers, randomized, double-blind, parallel-group, Phase 3 Trial to evaluate the efficacy and safety of CKD-843 in Male patients with Androgenetic Alopecia

Detailed Description

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The participants were randomly assigned to one of the following groups: CKD-843 dose #1, CKD-843 dose #2, placebo, or Dutasteride group. They received the assigned medication, placebo for blinding, or the reference drug over a 12-month period.

Conditions

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Androgenetic Alopecia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Test Group1

CKD-843 dose#1 + Placebo of Dutasteride Capsule

Group Type EXPERIMENTAL

CKD-843 dose#1

Intervention Type DRUG

IM injection every 3 months for 12 months

Placebo of Dutasteride Capsule

Intervention Type DRUG

oral, once daily, 12 months

Test Group2

CKD-843 dose#2 + Placebo of Dutasteride Capsule

Group Type EXPERIMENTAL

CKD-843 dose#2

Intervention Type DRUG

IM injection every 3 months for 12 months

Placebo of Dutasteride Capsule

Intervention Type DRUG

oral, once daily, 12 months

Placebo-controlled Group

Placebo of CKD-843 dose + Placebo of Dutasteride Capsule

Group Type PLACEBO_COMPARATOR

Placebo of CKD-843 dose

Intervention Type DRUG

IM injection every 3 months for 12 months

Placebo of Dutasteride Capsule

Intervention Type DRUG

oral, once daily, 12 months

Active-controlled Group

Placebo of CKD-843 dose + Dutasteride Capsules

Group Type ACTIVE_COMPARATOR

Placebo of CKD-843 dose

Intervention Type DRUG

IM injection every 3 months for 12 months

Dutasteride Capsules

Intervention Type DRUG

oral, once daily, 12 months

Interventions

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CKD-843 dose#1

IM injection every 3 months for 12 months

Intervention Type DRUG

CKD-843 dose#2

IM injection every 3 months for 12 months

Intervention Type DRUG

Placebo of CKD-843 dose

IM injection every 3 months for 12 months

Intervention Type DRUG

Dutasteride Capsules

oral, once daily, 12 months

Intervention Type DRUG

Placebo of Dutasteride Capsule

oral, once daily, 12 months

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male of age 18-50 years
* Clinical Diagnosis of Androgenetic Alopecia
* Written informed consent

Exclusion Criteria

* Other types of Alopecia or other diseases that can cause hair loss
* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Chong Kun Dang Pharmaceutical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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South Korea

Central Contacts

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OhSang Kwon, MD, PhD

Role: CONTACT

+2-2072-2417

Facility Contacts

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OhSang Kwon, MD, PhD

Role: primary

+2-2072-2417

Other Identifiers

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A107_03AGA2318

Identifier Type: -

Identifier Source: org_study_id

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