Alopecia Areata Clinical Trials

Find Alopecia Areata Clinical Trials Near You

A Phase 2, Randomized, Placebo-controlled, Double-blind Clinical Study to Evaluate Efficacy and Safety of LAD603 in Adult Subjects With Severe to Very Severe Alopecia Areata

Status: Recruiting
Location: See location...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

The main aim of the study is to evaluate the effect of LAD603 in adult participants with severe to very severe alopecia areata (AA). The study will also evaluate the safety, pharmacokinetics (PK), immunogenicity and pharmacodynamic (PD) biomarkers of LAD603.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• Participant is a male or female between 18 and 65 years old at the time of signing the informed consent.

• Severe to very severe AA criteria:

‣ Greater than or equal to (\>=) 50% hair loss of the scalp as measured by SALT without evidence of terminal hair regrowth within 6 months at both the Screening and Baseline (Day 1) visits.

⁃ Current episode of hair loss lasting at least 6 months and not exceeding 7 years.

• Participants who are WOCBP or male must agree to the requirements for the avoidance of pregnancy and exposure of the participant's partner to LAD603 during the study,

Locations
United States
Nebraska
Investigator Site 1
RECRUITING
Omaha
Contact Information
Primary
Davide Carluccio
gco@almirall.com
Backup
Estrella García
gco@almirall.com
Time Frame
Start Date: 2025-12-17
Estimated Completion Date: 2027-11-21
Participants
Target number of participants: 136
Treatments
Experimental: LAD603 Dose A
Participants will receive LAD603 Dose A , Subcutaneous (SC) injection from Day 1 up to 28 weeks.
Experimental: LAD603 Dose B
Participants will receive LAD603 Dose B, SC injection from Day 1 up to 28 weeks.
Experimental: LAD603 Dose C
Participants will receive LAD603 Dose C, SC injection from Day 1 up to 28 weeks.
Placebo_comparator: Placebo for LAD603
Participants will receive Placebo for LAD603 SC injection from Day 1 up to 28 weeks.
Sponsors
Leads: Almirall, S.A.

This content was sourced from clinicaltrials.gov