Dose-finding study of LAD603 in adults with alopecia areata

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Almirall S.A.

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17]

Trial duration

10 Apr 2026 → ongoing

Decision date (initial)

2026-03-30

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy, Pharmacokinetic, Pharmacodynamic, Dose response

​​To evaluate the clinical efficacy of LAD603 compared with placebo in adult patients with severe to very severe alopecia areata

Conditions and MedDRA coding

Alopecia areata

Regulatory references

Scientific advice from competent authorities

Food And Drug Administration

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. ​​Subject is a male or female between 18 and 65 years old at the time of signing the informed consent.​
2. ​​Subject is able to understand and willing to comply with study requirements as per Investigator’s opinion.​
3. ​​Subject provides written informed consent in accordance with institutional and regulatory guidelines, prior to any study-related procedures being performed.​
4. ​​AA criteria: a)​Patchy scalp hair loss (including ophiasis or sisaipho variants), alopecia totalis (AT), or alopecia universalis (AU): ​AT is defined as complete (100%) scalp hair loss. ​AU is defined as complete (100%) scalp, facial, and body hair loss. b)​≥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. c) ​Current episode of hair loss lasting at least 6 months and not exceeding 7 years.
5. ​​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​

Exclusion criteria 6

1. ​​Subjects have other types of alopecia (including but not limited to traction, scarring alopecia).​
2. ​​Subjects with "diffuse" type AA​
3. ​​History of male or female-pattern hair loss (>Hamilton stage III or >Ludwig stage II).​
4. ​​Subjects with history or presence of hair transplants.​
5. ​​Use of adhesive wigs, other than banded perimeter wigs, during the study.​
6. ​​Currently has an active form of other inflammatory skin disease(s) or evidence of skin condition (eg, 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. (For the avoidance of doubt, when no interference is expected, subjects could participate if they are otherwise eligible, including adhering to the allowed/permitted medication requirements.)​

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. ​​Percent change from baseline in the SALT score, at Week 28.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Almirall S.A.

Sponsor organisation

Almirall S.A.

Address

Ronda General Mitre 151

City

Barcelona

Postcode

08022

Country

Spain

Scientific contact point

Organisation

Almirall S.A.

Contact name

Almirall, S.A

Public contact point

Organisation

Almirall S.A.

Contact name

Almirall, S.A

Third parties 9

Locations

5 EU/EEA countries · 26 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 49 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications