A Phase 3 Study to Evaluate the Safety and Efficacy of CKD-843 in Male Patients With Androgenetic Alopecia

Chong Kun Dang

Status and phase: Not yet enrolling; Phase 3

Conditions: Androgenetic Alopecia

Treatments: Drug: Dutasteride Capsules; Drug: Placebo of Dutasteride Capsule; Drug: CKD-843 dose#2; Drug: CKD-843 dose#1; Drug: Placebo of CKD-843 dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT06916793

A107_03AGA2318

Details and patient eligibility

About

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

Full description

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.

Enrollment: 288 estimated patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

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

Key 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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288 participants in 4 patient groups, including a placebo group

Test Group1

Experimental group

Description:

CKD-843 dose#1 + Placebo of Dutasteride Capsule

Treatment:

Drug: CKD-843 dose#1

Drug: Placebo of Dutasteride Capsule

Test Group2

Experimental group

Description:

CKD-843 dose#2 + Placebo of Dutasteride Capsule

Treatment:

Drug: CKD-843 dose#2

Drug: Placebo of Dutasteride Capsule

Placebo-controlled Group

Placebo Comparator group

Description:

Placebo of CKD-843 dose + Placebo of Dutasteride Capsule

Treatment:

Drug: Placebo of CKD-843 dose

Drug: Placebo of Dutasteride Capsule

Active-controlled Group

Active Comparator group

Description:

Placebo of CKD-843 dose + Dutasteride Capsules

Treatment:

Drug: Placebo of CKD-843 dose

Drug: Dutasteride Capsules