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A Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of ALD-102 Solution in Subjects With Alopecia Areata | Clinical Trials | Clareo Health

RECRUITINGPHASE1/PHASE2

A Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of ALD-102 Solution in Subjects With Alopecia Areata

A Phase 1B/2A, Intraindividual Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of ALD-102 Solution for Intradermal Injection in Subjects With Alopecia Areata

NCT06826196•Aldena Therapeutics

View on ClinicalTrials.gov

Summary

The goal of this first-in-human clinical trial is to learn if ALD-102 Solution is safe and well tolerated following injections in the scalp in subjects with alopecia areata. The study will also learn about the effect of ALD-102 on hair regrowth in treatment areas. The researchers will compare the effects of ALD-102 Solution (drug) to placebo (saline solution that contains no drug) or an untreated area. Study participants will have treatment areas selected on the scalp to receive ALD-102 Solution (drug), placebo (saline solution) or to remain untreated. Injections will occur once every 4 weeks for a treatment period of 8 weeks.

Eligibility

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•In order to be eligible to participate in this study, a subject must meet all of the following criteria, either at the screening and Day 1 visits or only at 1 of the specified visits (screening or Day 1) as noted in the criterion:
•1. Male or female subject aged 18 to 55 years, inclusive, at the time of informed consent.
•2. Subject has a body mass index (BMI) between 18.0-35.0 kg/m2, inclusive, at screening.
•3. Subject has a body weight ≥ 50 kg, inclusive, at screening.
•4. Subject has a clinically confirmed diagnosis of AA at screening visit, based on investigator's judgement.
•5. For the treatment area(s) receiving ALD-102 Solution: subject must have AA lesion(s) that can accommodate the required number of injections per cohort: 20 injections for Cohorts 1#-3# and 40 injections for Cohort 4#.
•* A single scalp lesion of AA should preferably be selected as the treatment area to receive all injections.
•* For Cohorts 1#-3#: a total of 20 injections requires a scalp treatment area of 12 cm2 (1.86 in2).
•* For Cohort 4#: a total of 40 injections requires a scalp treatment area of 28 cm2 (4.34 in2).
•* If a single scalp lesion of AA cannot accommodate the full number of required injections per cohort, multiple scalp treatment areas may be selected:
+21 more criteria

Exclusion Criteria

•A subject who meets any of the following criteria at the screening and/or Day 1 visits, as applicable, will be excluded from participation in this study:
•1. Very severe AA, defined by SALT score ≥ 95 at screening and/or Day 1, including alopecia universalis and alopecia totalis.
•2. Presence of another form of alopecia (eg, androgenetic alopecia \[AGA\], traction and scarring alopecia, telogen effluvium).
•Note: Subjects with AGA are permitted only if the disorder is clinically distinct, physically separate, and does not affect or interfere with treatment or assessment of the selected treatment and control area(s) of AA. The diagnosis of AA should be clear and unambiguous, and the pattern and location of AGA should not overlap with or compromise the evaluation of the selected treatment and control areas of AA.
•3. Presence of diffuse type of AA. Note: Subjects with presence of ophiasis or siapho patterns of AA are allowed.
•4. History or presence of hair transplants.
•5. History or presence of micropigmentation of the scalp. Note: microblading of the eyebrows is permitted.
•6. Subject is a female who is breastfeeding, pregnant, or who is planning to become pregnant during the study.
•7. Subject is known to have immune deficiency or is immunocompromised.
•8. Subject has a history of cancer or lymphoproliferative disease within 5 years prior to Day 1. Subjects with successfully treated nonmetastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix are not to be excluded.
+44 more criteria

Locations (7)

Clinical Trial Research Institute

Thousand Oaks, California, United States

Options Research Group

West Lafayette, Indiana, United States

The Brigham and Women's Hospital

Boston, Massachusetts, United States

Dermatology Specialists of Spokane

Spokane, Washington, United States

The Centre for Clinical Trials

Oakville, Ontario, Canada

Innovaderm

Montreal, Quebec, Canada

Centre de Recherche Saint-Louis

Québec, Quebec, Canada

Key Dates

Start Date

March 24, 2025

Primary Completion Date

October 1, 2026

Completion Date

December 1, 2026

Last Updated

March 4, 2026

Enrollment

ESTIMATED participants

Conditions

Alopecia Areata (AA)

Interventions

ALD-102 Solution

DRUG

Placebo or Control

OTHER

Contacts

Chief Scientific Officer

CONTACT

+44 2045915017 info@aldenatherapeutics.com