Androgenetic AlopeciaPhase 2NCT06393452

Safety, Pharmacokinetics and Efficacy of PP405 in Adults With AGA

A Phase 2 study testing PP405 0.05% Topical Gel in people with Androgenetic Alopecia, run by Pelage Pharmaceuticals, Inc. at 8 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The study is a two part study, designed to validate safety results from the Phase 1 PP405-001 trial while also characterizing longer term safety and PK. Part 1 of the trial is the randomized controlled portion that will focus on safety and PK following 28 days of blinded treatment administration with either PP405 or… Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Androgenetic Alopecia
What is being tested?: PP405 0.05% Topical Gel
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 78 participants
Where: 8 sitesUnited States
Study dates: 5 Jun 2024to 1 Oct 2025
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Male or female subjects aged 18 to 55 years.
Able and willing to provide written informed consent.
Males must have an AGA modified Norwood-Hamilton Classification score of Type III vertex, Type IV or Type V. Females must have a Savin classification score of I-2, I-3 or I-4.
Agree to comply with protocol procedures

Who cannot join

Concomitant diagnosis of non-AGA forms of alopecia.
Use of other hair loss treatments within periods specified in protocol.
Use of excluded medications as specified in protocol.
Diagnosis of other medical conditions as specified in protocol.
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 locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

United States8 sites

DermResearch
Austin, Texas, 78759
California Dermatology & Clinical Research Institute
Encinitas, California, 92024
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, 46250
Minnesota Clinical Study Center
New Brighton, Minnesota, 55112
Virginia Clinical Research, Inc.
Norfolk, Virginia, 23502
Jordan Valley Dermatology Center
South Jordan, Utah, 84095
Stride Clinical Research LLC
Sugar Land, Texas, 77479
Clinical Trials Research Institute
Thousand Oaks, California, 91320

Other trials in United States

About this study

Official title: A Randomized, Multicenter, Double-blind, Vehicle-controlled, Phase 2a Study to Assess the Safety, Pharmacokinetics, and Efficacy of PP405 in Adults With Androgenetic Alopecia

Read the detailed description

Safety, Pharmacokinetics, and Efficacy Study of PP405 in subjects with Androgenetic Alopecia.

Conditions: Androgenetic Alopecia
Being tested: PP405 0.05% Topical Gel, Topical Vehicle Gel
Medical subject headings: Alopecia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PP405 0.05% Topical GelDrug
Also called PP405 0.05%
Medicated topical gel containing PP405 0.05%, applied once daily to the scalp
Topical Vehicle GelDrug
Also called Topical Placebo
Vehicle = placebo topical gel

Study groups in NCT06393452
Study group	Role	What they receive
PP405 0.05% Topical Gel	Active comparator	PP405 0.05% Topical Gel applied once daily for 28 days. Receives: Drug: PP405 0.05% Topical Gel
Topical Vehicle Gel, then PP405 0.05% Topical Gel	Placebo comparator	Topical Placebo Gel applied once daily for 28 days. Following the initial treatment and follow-up period through day 84, eligible subjects crossed over to apply PP405 0.05% topical gel for 84 days in an open-labeled extension. Receives: Drug: PP405 0.05% Topical Gel; Drug: Topical Vehicle Gel

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Subjects With Adverse Events
An adverse event that was not present when the active phase of the study began and was not a chronic condition that was part of the subject's medical history; or, it was present at the start of the active phase of the study or as part of the subject's medical history, but the severity or frequency increased during the active phase
Measured: Baseline to Day 84 of the randomized portion of the study
Percentage of Subjects With Adverse Events
An adverse event that was not present when the active phase of the study began and was not a chronic condition that was part of the subject's medical history; or, it was present at the start of the active phase of the study or as part of the subject's medical history, but the severity or frequency increased during the active phase
Measured: Baseline to Day 84 of the open label extension portion of the study
Change in Local Dermal Tolerability as Assessed by Subject and Investigator
Local skin reaction treatment emergent adverse events such as burning, pruritis, erythema
Measured: Post-dose at day 28 of the randomized portion of the study
Change in Local Dermal Tolerability as Assessed by Subject and Investigator
Local skin reaction treatment emergent adverse events such as burning, pruritis, erythema
Measured: Post-dose at day 84 of the open label extension portion of the study
Change From Baseline in Blood Pressure
Change from baseline in blood pressure in the safety analysis population (day 84 minus baseline)
Measured: Baseline to Day 84 of the randomized portion of the study
Change From Baseline in Pulse Rate
Change from baseline in pulse rate in the safety analysis population (day 84 minus baseline)
Measured: Baseline to Day 84 of the randomized portion of the study
Change From Baseline in Temperature
Change from baseline in temperature in the safety analysis population (day 84 minus baseline)
Measured: Baseline to Day 84 of the randomized portion of the study
Change From Baseline in Respiratory Rate
Change from baseline in respiratory rate in the safety analysis population (day 84 minus baseline)
Measured: Baseline to Day 84 of the randomized portion of the study
Change From Baseline in Weight
Change from baseline in weight in the safety analysis population (day 84 minus baseline)
Measured: Baseline to Day 84 of the randomized portion of the study
Change From Baseline in Blood Pressure
Change from baseline in blood pressure in the safety analysis population (open label extension day 84 minus open label extension baseline)
Measured: Baseline to Day 84 of the open label extension portion of the study
Change From Baseline in Pulse Rate
Change from baseline in pulse rate in the safety analysis population (open label extension day 84 minus open label extension baseline)
Measured: Baseline to Day 84 of the open label extension portion of the study
Change From Baseline in Temperature
Change from baseline in temperature in the safety analysis population (open label extension day 84 minus open label extension baseline)
Measured: Baseline to Day 84 of the open label extension portion of the study
Change From Baseline in Respiratory Rate
Change from baseline in respiratory rate in the safety analysis population (open label extension day 84 minus open label extension baseline)
Measured: Baseline to Day 84 of the open label extension portion of the study
Change From Baseline in Weight
Change from baseline in weight in the safety analysis population (open label extension day 84 minus open label extension baseline)
Measured: Baseline to Day 84 of the open label extension portion of the study
Change From Baseline in Mean Electrocardiogram Heart Rate
Electrocardiogram mean heart rate was compared to baseline (day 28 minus baseline)
Measured: Baseline to day 28 of the randomized portion of the study
Change From Baseline in Electrocardiogram (ECG) Results
Electrocardiograms results were compared to baseline (day 28 minus baseline)
Measured: Baseline to day 28 of the randomized portion of the study
Change From Baseline in Mean Electrocardiogram Heart Rate
Mean Electrocardiogram Heart Rate was compared to baseline of the open label extension study (day 84 minus baseline)
Measured: Baseline to day 84 of the open label extension portion of the study
Change From Baseline in Electrocardiograms (ECGs)
Electrocardiograms results were compared to baseline of the open label extension study (day 84 minus baseline)
Measured: Baseline to day 84 of the open label extension portion of the study
Abnormal Laboratory Values
Chemistry and hematology laboratory values were recorded as normal or abnormal (low or high)
Measured: Day 28 post baseline in the randomized portion of the study
Abnormal Laboratory Values
Chemistry and hematology laboratory values were recorded as normal or abnormal (low or high)
Measured: Day 84 post baseline in the open label extension portion of the study

Secondary outcomes (2)

Pharmacokinetics of PP405
To assess the concentration of PP405 in plasma
Measured: Baseline to Day 28 of the randomized portion of the study, assessed at 2 hours (±10 minutes) post-dose on day 1, day 14, and day 28
Pharmacokinetics of PP405
To assess the concentration of PP405 in plasma
Measured: Baseline to Day 84 of the open label extension portion of the study, assessed at 2 hours (±10 minutes) post-dose on day 1, day 28, day 56, and day 84

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Jun 20241 Oct 2025

First posted1 May 2024
Study start5 Jun 2024
Primary completion16 Jul 2025
Study completion1 Oct 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Androgenetic AlopeciaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Model description: Subjects who were randomized to vehicle in Part 1 were eligible to participate in the Open-label Extension in Part 2 of the study and receive PP405 0.05% topical gel.
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 78 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06393452
Sponsor's protocol ID: PP405-2001
Status last verified: Sep 2026
First submitted: 26 Apr 2024
Last updated: 21 Oct 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 2
Phase 2 Efficacy and Safety of PP405 in Adult Females With Androgenetic Alopecia
Androgenetic Alopecia
Not yet recruitingPhase 3
Phase 3 Study to Evaluate the Efficacy and Safety of Oral Minoxidil (N1087) in Men With Androgenetic Alopecia.
Androgenetic Alopecia, Androgenetic Alopecia (AGA)
Not yet recruiting
Study to Evaluate Xtressé Gummy Supplement in Women With Thinning Hair
Androgenetic Alopecia
Not yet recruitingEarly Phase 1
Evaluating the Efficacy of Platelet-rich Plasma Therapy in the Treatment of Androgenic Alopecia
Androgenic Alopecia
Not yet recruitingPhase 3
Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of N1087 in Participants With Female Pattern Hair Loss (MINORA-WOMEN)
Female Pattern Hair Loss, Female Pattern Hair Loss, Androgenic Alopecia

All Androgenetic Alopecia trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Multicenter, Double-blind, Vehicle-controlled, Phase 2a Study to Assess the Safety, Pharmacokinetics, and Efficacy of PP405 in Adults With Androgenetic Alopecia
ClinicalTrials.gov ID: NCT06393452
Acronym / sponsor ID: PP405-2001
Conditions: Androgenetic Alopecia
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 78 participants (actual)
Lead sponsor: Pelage Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
Study start: 5 Jun 2024 (actual)
Primary completion: 16 Jul 2025 (actual)
Study completion: 1 Oct 2025 (actual)
First posted: 1 May 2024 (actual)
Results: Posted 22 Sep 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Safety, Pharmacokinetics, and Efficacy Study of PP405 in subjects with Androgenetic Alopecia.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: Subjects who were randomized to vehicle in Part 1 were eligible to participate in the Open-label Extension in Part 2 of the study and receive PP405 0.05% topical gel.

Arm	Type	Receives
PP405 0.05% Topical Gel	Active comparator	Drug: PP405 0.05% Topical GelPP405 0.05% Topical Gel applied once daily for 28 days.
Topical Vehicle Gel, then PP405 0.05% Topical Gel	Placebo comparator	Drug: PP405 0.05% Topical Gel, Drug: Topical Vehicle GelTopical Placebo Gel applied once daily for 28 days. Following the initial treatment and follow-up period through day 84, eligible subjects crossed over to apply PP405 0.05% topical gel for 84 days in an open-labeled extension.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Male or female subjects aged 18 to 55 years.
Able and willing to provide written informed consent.
Males must have an AGA modified Norwood-Hamilton Classification score of Type III vertex, Type IV or Type V. Females must have a Savin classification score of I-2, I-3 or I-4.
Agree to comply with protocol procedures

Key exclusion criteria (5 listed)

Concomitant diagnosis of non-AGA forms of alopecia.
Use of other hair loss treatments within periods specified in protocol.
Use of excluded medications as specified in protocol.
Diagnosis of other medical conditions as specified in protocol.
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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PP405 0.05% Topical GelAlso: PP405 0.05%Medicated topical gel containing PP405 0.05%, applied once daily to the scalp	Drug	PP405 0.05% Topical Gel, Topical Vehicle Gel, then PP405 0.05% Topical Gel
Topical Vehicle GelAlso: Topical PlaceboVehicle = placebo topical gel	Drug	Topical Vehicle Gel, then PP405 0.05% Topical Gel

Primary outcome

Percentage of Subjects With Adverse Events
Time frame: Baseline to Day 84 of the randomized portion of the study
An adverse event that was not present when the active phase of the study began and was not a chronic condition that was part of the subject's medical history; or, it was present at the start of the active phase of the study or as part of the subject's medical history, but the severity or frequency increased during the active phase
Percentage of Subjects With Adverse Events
Time frame: Baseline to Day 84 of the open label extension portion of the study
An adverse event that was not present when the active phase of the study began and was not a chronic condition that was part of the subject's medical history; or, it was present at the start of the active phase of the study or as part of the subject's medical history, but the severity or frequency increased during the active phase
Change in Local Dermal Tolerability as Assessed by Subject and Investigator
Time frame: Post-dose at day 28 of the randomized portion of the study
Local skin reaction treatment emergent adverse events such as burning, pruritis, erythema
Change in Local Dermal Tolerability as Assessed by Subject and Investigator
Time frame: Post-dose at day 84 of the open label extension portion of the study
Local skin reaction treatment emergent adverse events such as burning, pruritis, erythema
Change From Baseline in Blood Pressure
Time frame: Baseline to Day 84 of the randomized portion of the study
Change from baseline in blood pressure in the safety analysis population (day 84 minus baseline)
Change From Baseline in Pulse Rate
Time frame: Baseline to Day 84 of the randomized portion of the study
Change from baseline in pulse rate in the safety analysis population (day 84 minus baseline)
Change From Baseline in Temperature
Time frame: Baseline to Day 84 of the randomized portion of the study
Change from baseline in temperature in the safety analysis population (day 84 minus baseline)
Change From Baseline in Respiratory Rate
Time frame: Baseline to Day 84 of the randomized portion of the study
Change from baseline in respiratory rate in the safety analysis population (day 84 minus baseline)
Change From Baseline in Weight
Time frame: Baseline to Day 84 of the randomized portion of the study
Change from baseline in weight in the safety analysis population (day 84 minus baseline)
Change From Baseline in Blood Pressure
Time frame: Baseline to Day 84 of the open label extension portion of the study
Change from baseline in blood pressure in the safety analysis population (open label extension day 84 minus open label extension baseline)
Change From Baseline in Pulse Rate
Time frame: Baseline to Day 84 of the open label extension portion of the study
Change from baseline in pulse rate in the safety analysis population (open label extension day 84 minus open label extension baseline)
Change From Baseline in Temperature
Time frame: Baseline to Day 84 of the open label extension portion of the study
Change from baseline in temperature in the safety analysis population (open label extension day 84 minus open label extension baseline)
Change From Baseline in Respiratory Rate
Time frame: Baseline to Day 84 of the open label extension portion of the study
Change from baseline in respiratory rate in the safety analysis population (open label extension day 84 minus open label extension baseline)
Change From Baseline in Weight
Time frame: Baseline to Day 84 of the open label extension portion of the study
Change from baseline in weight in the safety analysis population (open label extension day 84 minus open label extension baseline)
Change From Baseline in Mean Electrocardiogram Heart Rate
Time frame: Baseline to day 28 of the randomized portion of the study
Electrocardiogram mean heart rate was compared to baseline (day 28 minus baseline)
Change From Baseline in Electrocardiogram (ECG) Results
Time frame: Baseline to day 28 of the randomized portion of the study
Electrocardiograms results were compared to baseline (day 28 minus baseline)
Change From Baseline in Mean Electrocardiogram Heart Rate
Time frame: Baseline to day 84 of the open label extension portion of the study
Mean Electrocardiogram Heart Rate was compared to baseline of the open label extension study (day 84 minus baseline)
Change From Baseline in Electrocardiograms (ECGs)
Time frame: Baseline to day 84 of the open label extension portion of the study
Electrocardiograms results were compared to baseline of the open label extension study (day 84 minus baseline)
Abnormal Laboratory Values
Time frame: Day 28 post baseline in the randomized portion of the study
Chemistry and hematology laboratory values were recorded as normal or abnormal (low or high)
Abnormal Laboratory Values
Time frame: Day 84 post baseline in the open label extension portion of the study
Chemistry and hematology laboratory values were recorded as normal or abnormal (low or high)

2 secondary outcomes

Pharmacokinetics of PP405
Time frame: Baseline to Day 28 of the randomized portion of the study, assessed at 2 hours (±10 minutes) post-dose on day 1, day 14, and day 28
Pharmacokinetics of PP405
Time frame: Baseline to Day 84 of the open label extension portion of the study, assessed at 2 hours (±10 minutes) post-dose on day 1, day 28, day 56, and day 84

Results and safety

Results posted to the registry on 22 Sep 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PP405 0.05% Topical Gel Randomized Control Trial (28 Days of Treatment With Follow up to 84 Days)	51	49
Topical Vehicle Gel (Randomized), Then PP405 0.05% Topical Gel (Open Label Extension)	27	25

Primary outcome: Percentage of Subjects With Adverse Events

Time frame: Baseline to Day 84 of the randomized portion of the study. Count of participants. Unit: Participants

Measure	PP405 0.05% Topical Gel (Randomized Controlled Trial Period) n = 51	Vehicle Gel (Randomized Controlled Trial Period) n = 27
At least one adverse event	22	10
At least one treatment-emergent adverse event	22	10
At least one serious treatment-emergent adverse event	0	1

Population analysed: Safety analysis population of all subjects who received any amount of study drug

Primary outcome: Percentage of Subjects With Adverse Events

Time frame: Baseline to Day 84 of the open label extension portion of the study. Count of participants. Unit: Participants

Measure	PP405 0.05% Topical Gel (Open Label Extension Period) n = 20
At least one adverse event	8
At least one treatment-emergent adverse event	8
At least one serious treatment-emergent adverse event	0

Population analysed: Safety analysis population of all subjects who received any amount of study drug

Primary outcome: Change in Local Dermal Tolerability as Assessed by Subject and Investigator

Time frame: Post-dose at day 28 of the randomized portion of the study. Count of participants. Unit: Participants

Measure	PP405 0.05% Topical Gel (Randomized Controlled Trial Period) n = 51	Vehicle Gel (Randomized Controlled Trial Period) n = 26
Edema-investigator assessment: 0-None	51	26
Edema-investigator assessment: 1-Mild	0	0
Edema-investigator assessment: 2-Moderate	0	0
Edema-investigator assessment: 3-Severe	0	0
Erythema-investigator assessment: 0-None	50	25
Erythema-investigator assessment: 1-Mild	1	1
Erythema-investigator assessment: 2-Moderate	0	0
Erythema-investigator assessment: 3-Severe	0	0

Population analysed: Safety analysis population of all subjects who received any amount of study drug

Primary outcome: Change in Local Dermal Tolerability as Assessed by Subject and Investigator

Time frame: Post-dose at day 84 of the open label extension portion of the study. Count of participants. Unit: Participants

Measure	PP405 0.05% Topical Gel (Open Label Extension Period) n = 16
Edema-investigator assessment: 0-None	16
Edema-investigator assessment: 1-Mild	0
Edema-investigator assessment: 2-Moderate	0
Edema-investigator assessment: 3-Severe	0
Erythema-investigator assessment: 0-None	15
Erythema-investigator assessment: 1-Mild	1
Erythema-investigator assessment: 2-Moderate	0
Erythema-investigator assessment: 3-Severe	0

Population analysed: Safety analysis population of all subjects who received any amount of study drug in the open label extension portion of the study

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Day 1 through day 84 of the randomized controlled portion of the study, and day 1 through day 168 of the open label extension portion of the study. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PP405 0.05% Topical Gel (Randomized Controlled Trial)	0 of 51 (0%)	22 of 51 (43.1%)	0 of 51
Topical Vehicle Gel (Randomized Controlled Trial)	1 of 27 (3.7%)	10 of 27 (37%)	0 of 27
PP405 0.05% Topical Gel (Open Label Extension)	0 of 20 (0%)	8 of 20 (40%)	0 of 20

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Androgenetic Alopecia

Not yet recruitingPhase 2
Phase 2 Efficacy and Safety of PP405 in Adult Females With Androgenetic Alopecia
Androgenetic Alopecia
Not yet recruitingPhase 3
Phase 3 Study to Evaluate the Efficacy and Safety of Oral Minoxidil (N1087) in Men With Androgenetic Alopecia.
Androgenetic Alopecia, Androgenetic Alopecia (AGA)
Not yet recruiting
Study to Evaluate Xtressé Gummy Supplement in Women With Thinning Hair
Androgenetic Alopecia
Not yet recruitingEarly Phase 1
Evaluating the Efficacy of Platelet-rich Plasma Therapy in the Treatment of Androgenic Alopecia
Androgenic Alopecia
Not yet recruitingPhase 3
Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of N1087 in Participants With Female Pattern Hair Loss (MINORA-WOMEN)
Female Pattern Hair Loss, Female Pattern Hair Loss, Androgenic Alopecia

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Christina Weng study chair

Pelage Pharmaceuticals

8 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PP405 0.05% Topical Gel in people with Androgenetic Alopecia, run by Pelage Pharmaceuticals, Inc. at 8 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Subjects With Adverse Events (time frame: Baseline to Day 84 of the randomized portion of the study). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06393452.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.