Phase 2/3 Efficacy and Safety of PP405 in Adult Males (AWAKEN)

Pelage Pharmaceuticals, Inc.

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Androgenetic Alopecia

Treatments: Drug: Vehicle Topical Gel; Drug: PP405 0.05% Topical Gel

Study type: Interventional

Funder types: Industry

Identifiers

NCT07819435

PP405-2002

Details and patient eligibility

About

The study is designed to validate efficacy and long term safety of PP405.

Full description

Participants will initially be randomized 1:1 to PP405 or vehicle and complete a 24 week double blinded treatment period. At Week 24, the PP405 group will continue PP405 treatment, and the vehicle group will be re-randomized 1:1 to PP405 or vehicle for the double-blind long term safety extension period through study week 52.

Enrollment: 600 estimated patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Males (assigned at birth) aged 18 to 55 years, inclusive at time of consent.
2. Able and willing to provide written informed consent
3. Must have been experiencing Androgenetic Alopecia (AGA) for at least 6 months prior to screening.
4. Have a modified Norwood-Hamilton score of Type IV or Type V
5. Agree to comply with protocol procedures

Exclusion criteria

1. Concomitant diagnosis of non-AGA forms of alopecia.
2. Use of other hair loss treatments within periods specified in protocol.
3. Use of excluded medications and procedures as specified in protocol.
4. Diagnosis of other medical conditions as specified in protocol.
5. Any disease or medical condition that, in the opinion of the Investigator, would prevent the subject from participating in the study or might confound study results.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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600 participants in 2 patient groups, including a placebo group

PP405 0.05% Topical Gel

Experimental group

Description:

PP405 applied to the scalp from Day 1 to Week 24; then continuing PP405 from Week 24 to Week 52.

Treatment:

Drug: PP405 0.05% Topical Gel

Vehicle Topical Gel

Placebo Comparator group

Description:

Vehicle applied to the scalp from Day 1 to Week 24; then re-randomized 1:1 to receive either PP405 or vehicle QD from Week 24 to Week 52

Treatment:

Drug: PP405 0.05% Topical Gel

Drug: Vehicle Topical Gel