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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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • LAD603

    Drug

    LAD603 administered subcutaneously.

  • Placebo

    Other intervention

    LAD603 matching placebo administered subcutaneously.

Treatment groups

136 Participants
are divided into 4 treatment groups
Group A: LAD603 Dose AExperimental treatment 1 intervention
Group B: LAD603 Dose BExperimental treatment 1 intervention
Group C: LAD603 Dose CExperimental treatment 1 intervention
Group D: Placebo for LAD603Placebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Percent Change from Baseline in the Severity of Alopecia Tool (SALT) Score

The SALT score is the sum of percentage of hair loss in all areas with a maximum score of 100 (higher score indicates greater hair loss).

Time frame
Baseline, Week 28

Secondary outcomes

1

Percentage of Participants Achieving an Absolute SALT Score Less than or Equal to (<=) 10/20

Percentage of participants achieving an absolute SALT score of \<= 10/20. The SALT score is the sum of percentage of hair loss in all areas with a maximum score of 100 (higher score indicates greater hair loss). Total percentage of patients with absolute SALT score of \<= 10/20 will be calculated.

Time frame
At Week 28
2

Percentage of Participants Achieving a Clinician-Reported Outcome (ClinRO) for Eyelash Hair Loss of 0/1

The ClinROs for Eyelash Hair Loss is a clinician reported assessment which measures the severity and impact of hair loss in these specific areas. It comprises a 4-point category response options (0 to 3) rating the extent of eyebrow hair loss. This scale ranges from no hair loss (0) to complete hair loss (3).

Time frame
At Week 28
3

Percentage of Participants Achieving a ClinRO for Eyebrow Hair Loss of 0/1

The ClinROs for Eyebrow Hair is a clinician reported assessment which measures the severity and impact of hair loss in these specific areas. It comprises a 4-point category response options (0 to 3) rating the extent of eyebrow hair loss. This scale ranges from no hair loss (0) to complete hair loss (3).

Time frame
At Week 28

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Almirall, S.A.

Lead sponsor

Source ClinicalTrials.gov
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