A Study of LAD603 in Adults With Alopecia Areata
ConditionAlopecia Areata
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAlmirall, S.A.
About this trial
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 criteria
Qualifiers
Participant is a male or female between 18 and 65 years old at the time of signing the informed consent.
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,
Disqualifiers
Participants have other types of alopecia (including but not limited to traction, scarring alopecia).
Participants with "diffuse" type AA.
Currently has an active form of other inflammatory skin disease(s) or evidence of skin condition (e.g., psoriasis, seborrheic dermatitis, lupus) at the time of the Screening or Baseline (Day 1) visits that is expected to interfere with the assessment of alopecia areata severity.
Participant has previous severe adverse reaction to subcutaneously administered medication.
Trial design
Treatments tested in this trial
- LAD603
- Placebo
Treatment groups
136 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov