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ARISENCT06826196

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

StatusActive, Not Recruiting
PhasePhase 1/2
Primary completion (estimated)
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Record History

All 5 versions: 5 with changes below. See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria shortened, about 153 words Show 5 more changesShow less
    • Enrollment closed, study ongoing
    • Final enrollment: 9 participants (planned 24)
    • Study sites: 7 to 8
    • Primary completion date: Oct 2026 to Nov 2026
    • Secondary endpoints: details revised at 1 of 1 entry
  2. Primary completion date: Feb 2026 to Oct 2026v4 Show 6 more changesShow less
    • Eligibility criteria expanded, about 504 words
    • Primary endpoint revised
    • Study sites: 5 to 7
    • Study completion date: Jun 2026 to Dec 2026
    • Interventions: ALD-102 (Drug), Placebo (Drug) to ALD-102 Solution (Drug), Placebo or Control (Other)
    • Secondary endpoints: details revised at 1 of 1 entry
  3. Site details revised at 2 of 5 sitesv3
  4. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 5
    • Start date changed from estimate of Feb 2025 to Mar 24, 2025
    v2
  5. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

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.
Timeframe: Clinical assessments during treatment and follow up period for a total of 24 weeks.

Secondary (1)

Concentration of ALD-102 in skin biopsies at Week 10 and plasma concentration of ALD-102 over time.

Arms and interventions

Control: Placebo or Untreated AreaOther
ALD-102 SolutionExperimental

Drugs: ALD-102 Solution

Other: Placebo or Control

Sites

8 sites in 2 countries

United States 5, Canada 3