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Study of ALD-102 Solution for Alopecia Areata

This study is testing a new treatment called ALD-102 Solution for people with alopecia areata (a condition causing hair loss). It's a "first-in-human" study, meaning it's the first time this treatment is being given to people. Researchers want to see if ALD-102 Solution is safe and well-tolerated when injected into the scalp, and if it helps hair regrow. You would receive ALD-102 Solution, a placebo (a solution without medicine), or have an untreated area on your scalp. Injections happen every 4 weeks for 8 weeks. The study is looking for 24 participants between 18 and 55 years old.

Study design
This is an interventional study, but the phase is not specified. It involves comparing ALD-102 Solution to a placebo or an untreated area in 24 participants.
What's involved
You would receive injections into your scalp every 4 weeks for a total of 8 weeks. There will be clinical assessments during treatment and a follow-up period.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for a total of 24 weeks after starting treatment.

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NCT06826196

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

Recruiting
PHASE1Ages 18–55InterventionalTreatment
Aldena Therapeutics
~24 participants
Updated 2026-03-04 on ClinicalTrials.gov
What's tested:ALD-102 SolutionPlacebo or Control

At a glance

Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with treatment-related adverse effects (AEs) and severe adverse effects (SAEs) as assessed by CTCAE, and injection site reactions (ISRs), evaluated by local tolerability assessments and numerical scales.
Measured over Clinical assessments during treatment and follow up period for a total of 24 weeks.

Conditions

Alopecia Areata (AA)

Explore related trials

Alopecia

Where it's being run

7 sites across 6 states
Quebec2
California1
Indiana1
Massachusetts1
Washington1
Ontario1

Who to contact

Chief Scientific Officer
[email protected]
+44 2045915017
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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:
All selected treatment area(s) must display a near-complete or complete absence of terminal hairs and should be clinically similar, as judged by the investigator. 6. For the control area:
Cohorts 1# and 2#: subjects must have a control AA scalp lesion selected measuring approximately 2 cm² (0.31 in2) to receive 6 placebo injections. This area should be located ≥ 6 cm from the designated treatment area(s), exhibit a near-complete or complete absence of terminal hairs, be clinically similar to the selected treatment area(s) as judged by the investigator, and preferably be positioned contralaterally to one of the selected treatment areas.
Cohorts 3# and 4#: subjects must have an untreated AA scalp lesion selected measuring at least 2 cm² (0.31 in2). This area should be located ≥ 6 cm from the designated treatment areas, exhibit a near-complete or complete absence of terminal hairs, be clinically similar to the selected treatment area(s) as judged by the investigator, and preferably be positioned contralaterally to one of the selected treatment areas. 7. Duration of current episode of hair loss at the treatment and control areas \> 6 months but \< 5 years at screening and Day 1, along with investigators' assessment that hair regrowth is possible. Total duration of current episode of hair loss outside of treatment and control areas and total duration since diagnosis of AA could be \> 5 years. 8. No evidence of active regrowth or hair loss present at baseline and no known history of significant regrowth or hair loss, as per investigator's judgement, over the last 6 months. 9. Subject is willing to keep the same hairstyle and color (eg, hair products, process, and timing for hair appointments) for the duration of the trial.
Female subject who has had surgical sterilization (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy)
Female subject who has had a cessation of menses for ≥ 12 months prior to the screening visit without an alternative medical cause, and a follicle-stimulating hormone (FSH) test confirming nonchildbearing potential (refer to laboratory reference ranges for confirmatory levels). 11. For male subject involved in any sexual intercourse that could lead to pregnancy, subject must agree to use a condom and their female partner must use one of the highly effective contraceptive methods listed in Inclusion Criterion #10, from Day 1 until ≥ 16 weeks after the last injection and refrain from donating sperm during this period. If the female partner of a male subject uses any of the hormonal contraceptive methods listed above, this contraceptive method should be used by the female partner from ≥ 4 weeks before Day 1 until ≥ 16 weeks after the last injection. 12. Female subject of childbearing potential must have a negative serum pregnancy test at screening and negative urine pregnancy test at Day 1. 13. Subject is willing to participate and is capable of giving a signed and dated informed consent.

What this trial measures

  • Number of participants with treatment-related adverse effects (AEs) and severe adverse effects (SAEs) as assessed by CTCAE, and injection site reactions (ISRs), evaluated by local tolerability assessments and numerical scales.Clinical assessments during treatment and follow up period for a total of 24 weeks.

    AEs assessed by guidelines outlined in CTCAE at baseline, during treatment and follow-up periods. ISRs assessed by local tolerability assessments (LTA), including evaluation by the investigator of erythema, swelling, induration, and bruising, and evaluation by the subject of burning, stinging and itching. Grading using a 4-point scale of 0 to 3 (non, mild, moderate, severe) will be used to assess each sign. Pain at each treatment area will also be assessed using a pain numerical rating scale (NRS). Subjects will be asked to assign a numerical score representing the average pain intensity on a scale of 0 to 10, experienced during and after product administration. The LTA will be done during injection days and during the follow up period.