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Taking people in United StatesPhase 2

LAD603 for adults with severe alopecia areata

Tests LAD603 against placebo in adults with severe to very severe alopecia areata.

Key facts

Who runs it
Almirall, S.A.
Where
Omaha, United StatesSee the siteAlso in 5 other countries, 26 sites
Registry title
A Study of LAD603 in Adults With Alopecia Areata
Status
Recruiting
Phase
Phase 2
People taking part
136 people, planned
Started
17 Dec 2025
Expected to end
21 Nov 2027
Type of study
Interventional, 4 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • LAD603
  • Placebo
Record updated
20 May 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with severe to very severe alopecia areata, an illness that causes patchy hair loss. It tests LAD603 against a placebo (dummy injection).

Age
18 to 65 years
Sex
Male and female
Disease stage
Severe to very severe alopecia areata: >=50% hair loss of the scalp (measured by SALT), with no regrowth of full hair within 6 months. The current episode of hair loss has lasted at least 6 months and not more than 7 years.
Earlier treatment
People must stop certain medicines not allowed by the protocol, for the waiting time it sets.

Main reasons for not taking part

  • Other types of hair loss, such as traction or scarring alopecia, or the "diffuse" type of alopecia areata
  • Another active skin disease, such as psoriasis, seborrheic dermatitis or lupus, that would interfere with judging hair loss
  • A severe reaction in the past to a medicine given as an injection under the skin
  • Abnormal liver blood tests at screening: ALT or AST >=2.5 × ULN, total bilirubin >=1.5 × ULN (>=3 × ULN with Gilbert's syndrome), or ALP >=1.5 × ULN
  • Plans to use medicines not allowed by the protocol

The registry criteria, word for word

Show all 10 criteriaShow less

Who can take part

  • 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,

Who cannot take part

  • Participant has previous severe adverse reaction to subcutaneously administered medication
  • 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
  • AA, Skin Specific, and Other Inflammatory Diseases
  • 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 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
  • Participants have other types of alopecia (including but not limited to traction, scarring alopecia)
  • Participants with "diffuse" type AA

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 65 years old?

Where in United States

Also in 5 other countries, 26 sites

  • Omaha, NebraskaHospital not named in the registryContact: Davide CarluccioTaking people

About the trial

What the trial wants to find out

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.

The 4 groups in the trial

  • LAD603 Dose ATreatment being tested

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

    Treatment: LAD603

  • LAD603 Dose BTreatment being tested

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

    Treatment: LAD603

  • LAD603 Dose CTreatment being tested

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

    Treatment: LAD603

  • Placebo for LAD603Placebo, for comparison

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

    Treatment: Placebo

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
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
Plain-language title
LAD603 for adults with severe alopecia areataGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Fit questions
Built from NCT07311564, who can take part
Record updated
20 May 2026