NCT07311564

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
136

participants targeted

Target at P75+ for phase_2

Timeline
18mo left

Started Dec 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress20%
Dec 2025Nov 2027

Study Start

First participant enrolled

December 17, 2025

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

December 29, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 31, 2025

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 23, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 21, 2027

Last Updated

January 12, 2026

Status Verified

January 1, 2026

Enrollment Period

1.4 years

First QC Date

December 29, 2025

Last Update Submit

January 9, 2026

Conditions

Alopecia Areata

Keywords

Hair LossHypotrichosisAlopecia

Outcome Measures

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).

    Baseline, Week 28

Secondary Outcomes (3)

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

    At Week 28

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

    At Week 28

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

    At Week 28

Study Arms (4)

LAD603 Dose A

EXPERIMENTAL

Participants will receive LAD603 Dose A , Subcutaneous (SC) injection from Day 1 up to 28 weeks.

Drug: LAD603

LAD603 Dose B

EXPERIMENTAL

Participants will receive LAD603 Dose B, SC injection from Day 1 up to 28 weeks.

Drug: LAD603

LAD603 Dose C

EXPERIMENTAL

Participants will receive LAD603 Dose C, SC injection from Day 1 up to 28 weeks.

Drug: LAD603

Placebo for LAD603

PLACEBO COMPARATOR

Participants will receive Placebo for LAD603 SC injection from Day 1 up to 28 weeks.

Other: Placebo

Interventions

LAD603DRUG

LAD603 administered subcutaneously.

LAD603 Dose ALAD603 Dose BLAD603 Dose C
PlaceboOTHER

LAD603 matching placebo administered subcutaneously.

Placebo for LAD603

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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,

You may not qualify if:

  • AA, Skin Specific, and Other Inflammatory Diseases
  • 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.
  • Other Medical Conditions
  • Participant has previous severe adverse reaction to subcutaneously administered medication.
  • Participant has any of the following liver safety laboratory results at Screening
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than or equal to (\>=) 2.5 × upper limit of normal (ULN)
  • Total bilirubin (TBL) \>=1.5 × ULN (TBL \>=3 × ULN in participants with Gilbert's syndrome)
  • Alkaline phosphatase (ALP) \>=1.5 × ULN
  • Prior/Concomitant Therapy
  • Intention to use any concomitant medication that is not permitted by this protocol or failure to undergo the required washout period for a particular prohibited medication.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Investigator Site 1

Omaha, Nebraska, 68144, United States

RECRUITING

MeSH Terms

Conditions

Alopecia AreataAlopeciaHypotrichosis

Condition Hierarchy (Ancestors)

Hair DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Study Director

    Almirall, S.A.

    STUDY DIRECTOR

Central Study Contacts

Davide Carluccio

CONTACT

gco@almirall.com

Estrella García

CONTACT

gco@almirall.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 29, 2025

First Posted

December 31, 2025

Study Start

December 17, 2025

Primary Completion (Estimated)

May 23, 2027

Study Completion (Estimated)

November 21, 2027

Last Updated

January 12, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)