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

Conditions

• Alopecia Areata (AA)

Eligibility Criteria

Sex

ALL

Age

18 Years - 55 Years

Healthy Volunteers

Not accepted

Interventions

• ALD-102 Solution — DRUG
  Treatment every 4 weeks for total of 8-week treatment period.
• Placebo or Control — OTHER
  Treatment every 4 weeks for 8-week treatment period

Study Details

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.

Key Dates

Start date

Mar 24, 2025

Status verified

Mar 2026

Primary completion

Oct 31, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

24 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Other: Control: Placebo or Untreated Area
• Experimental: ALD-102 Solution

Primary Outcome Measure

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. [ Time Frame: Clinical assessments during treatment and follow up period for a total of 24 weeks. ]

Central Contacts

• Chief Scientific Officer
  +44 2045915017
  [email protected]

Locations (4)

Find similar trials in Thousand Oaks, CA