A Study of DR-01 in Subjects With Alopecia Areata and Vitiligo

Phase 1

Recruiting

• Conditions: Alopecia Areata; Vitiligo
• Interventions: Drug: DR-01

• Registration Number: NCT06602232
• Lead Sponsor: Dren Bio

Brief Summary

This is a multi-center, parallel-group, open-label, randomized, Phase 1b study to explore the safety, clinical activity, pharmacokinetics and pharmacodynamics of DR-01 in adults with Alopecia Areata or Vitiligo.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-16
• Study First Submitted QC: 2024-09-16
• Study First Posted: 2024-09-19
• Study Start: 2024-10-30
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-31
• Last Update Posted: 2025-01-01
• Primary Completion: 2026-09
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DL2 of DR-01	DR-01	Subjects in this arm will receive up to 6 months of dosing with DR-01 at dose level 2
DL-3 of DR-01	DR-01	Subjects in this arm will receive up to 6 months of dosing with DR-01 at dose level 3
DL1 of DR-01	DR-01	Subjects in this arm will receive up to 6 months of dosing with DR-01 at dose level 1

Primary Outcome Measures

Name	Time	Method
Incidence and severity of adverse events as assessed by CTCAE v5.0.(Safety and Tolerability)	Up to 12 months
Mean change from baseline in SALT score	At week 24
Mean change from baseline in VASI measures	At week 24

Trial Locations

Locations (1)

Dren Investigational Site; 🇳🇿 Grafton, New Zealand