Phase 2/3 Efficacy and Safety of PP405 in Adult Males With NHS Type IV/V (AWAKEN)

September 9, 2026 updated by: Pelage Pharmaceuticals, Inc.

A Randomized, Multicenter, Double-blind, Vehicle-controlled, Phase 2/3 Study to Assess Efficacy and Long-Term Safety of PP405 in Adult Males With Androgenetic Alopecia

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

600

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PP405 0.05% Topical Gel
PP405 applied to the scalp from Day 1 to Week 24; then continuing PP405 from Week 24 to Week 52.
Drug: PP405 0.05% Topical Gel
Medicated topical gel containing PP405 0.05%
Other Names:
  • PP405
Placebo Comparator: Vehicle Topical Gel
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
Drug: PP405 0.05% Topical Gel
Medicated topical gel containing PP405 0.05%
Other Names:
  • PP405
Drug: Vehicle Topical Gel
Topical gel
Other Names:
  • Vehicle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in non-vellus target area hair count
Time Frame: Week 24
Change from baseline in non-vellus target area hair count (nvTAHC) at the vertex
Week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in the Participant Assessment of Scalp Coverage
Time Frame: Week 24
Change from baseline in the Participant Assessment of Scalp Coverage (PASC), where higher scores correspond to greater coverage
Week 24
≥20% increase from baseline in non-vellus target area hair count
Time Frame: week 24
Proportion of participants with ≥20% increase from baseline in non-vellus target area hair count
week 24
Change from baseline in non-vellus target area hair count
Time Frame: Week 12
Change from baseline in non-vellus target area hair count (nvTAHC) at the vertex
Week 12
Change from baseline in the Participant Assessment of Scalp Coverage
Time Frame: Week 12
Change from baseline in the Participant Assessment of Scalp Coverage (PASC), where higher scores correspond to greater coverage
Week 12
≥20% increase from baseline in non-vellus target area hair count
Time Frame: week 12
Proportion of participants with ≥20% increase from baseline in non-vellus target area hair count
week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pelage Pharmaceuticals, Inc.

Investigators

  • Study Chair: Christina Weng, Pelagepharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

September 9, 2026

First Submitted That Met QC Criteria

September 9, 2026

First Posted (Actual)

September 15, 2026

Study Record Updates

Last Update Posted (Actual)

September 15, 2026

Last Update Submitted That Met QC Criteria

September 9, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PP405-2002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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