Alopecia AreataPhase 2NCT07311564
A Study of LAD603 in Adults With Alopecia Areata
A Phase 2 study testing LAD603 in people with Alopecia Areata, run by Almirall, S.A. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Alopecia Areata
- What is being tested?
- LAD603
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 136 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Dec 2025to 21 Nov 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Davide Carluccio contact
Estrella García contact
United States1 site, 1 recruiting
- Recruiting
Investigator Site 1
Omaha, Nebraska, 68144
About this study
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
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.
- Conditions
- Alopecia Areata
- Being tested
- LAD603, Placebo
- Keywords
- Hair Loss, Hypotrichosis, Alopecia
- Medical subject headings
- Alopecia Areata, Alopecia, Hypotrichosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LAD603Drug
LAD603 administered subcutaneously.
PlaceboOther
LAD603 matching placebo administered subcutaneously.
| Study group | Role | What they receive |
|---|---|---|
| LAD603 Dose A | Experimental | Participants will receive LAD603 Dose A , Subcutaneous (SC) injection from Day 1 up to 28 weeks. Receives: Drug: LAD603 |
| LAD603 Dose B | Experimental | Participants will receive LAD603 Dose B, SC injection from Day 1 up to 28 weeks. Receives: Drug: LAD603 |
| LAD603 Dose C | Experimental | Participants will receive LAD603 Dose C, SC injection from Day 1 up to 28 weeks. Receives: Drug: LAD603 |
| Placebo for LAD603 | Placebo comparator | Participants will receive Placebo for LAD603 SC injection from Day 1 up to 28 weeks. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline, Week 28
Secondary outcomes (3)
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.
Measured: At Week 28
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).
Measured: At Week 28
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).
Measured: At Week 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2025
- Study start17 Dec 2025
- Primary completion23 Jun 2027 (estimated)
- Study completion21 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alopecia AreataStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Almirall, S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Almirall, S.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07311564
- Sponsor's protocol ID
- M-00223-20
- Other IDs
- 2025-523342-27-00, 2025
- Status last verified
- Jan 2026
- First submitted
- 29 Dec 2025
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07311564
- Acronym / sponsor ID
- M-00223-20
- Conditions
- Alopecia Areata
- Keywords
- Hair Loss, Hypotrichosis, Alopecia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- Almirall, S.A.Industry (pharma, biotech, devices)
- Study start
- 17 Dec 2025 (actual)
- Primary completion
- 23 Jun 2027 (estimated)
- Study completion
- 21 Nov 2027 (estimated)
- First posted
- 31 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| LAD603 Dose A | Experimental | Drug: LAD603Participants will receive LAD603 Dose A , Subcutaneous (SC) injection from Day 1 up to 28 weeks. |
| LAD603 Dose B | Experimental | Drug: LAD603Participants will receive LAD603 Dose B, SC injection from Day 1 up to 28 weeks. |
| LAD603 Dose C | Experimental | Drug: LAD603Participants will receive LAD603 Dose C, SC injection from Day 1 up to 28 weeks. |
| Placebo for LAD603 | Placebo comparator | Other: PlaceboParticipants will receive Placebo for LAD603 SC injection from Day 1 up to 28 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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:
- 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,
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LAD603LAD603 administered subcutaneously. | Drug | LAD603 Dose A, LAD603 Dose B, LAD603 Dose C |
| PlaceboLAD603 matching placebo administered subcutaneously. | Other | Placebo for LAD603 |
Primary outcome
Percent Change from Baseline in the Severity of Alopecia Tool (SALT) Score
Time frame: Baseline, Week 28
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).
3 secondary outcomes
Percentage of Participants Achieving an Absolute SALT Score Less than or Equal to (<=) 10/20
Time frame: At Week 28
Percentage of Participants Achieving a Clinician-Reported Outcome (ClinRO) for Eyelash Hair Loss of 0/1
Time frame: At Week 28
Percentage of Participants Achieving a ClinRO for Eyebrow Hair Loss of 0/1
Time frame: At Week 28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Davide Carluccio contact
Estrella García contact
Study Director study director
Almirall, S.A.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LAD603 in people with Alopecia Areata, run by Almirall, S.A. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Davide Carluccio (gco@almirall.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change from Baseline in the Severity of Alopecia Tool (SALT) Score (time frame: Baseline, Week 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.