LAD603 for Alopecia Areata
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called LAD603 for individuals with severe to very severe alopecia areata, a condition causing significant hair loss on the scalp. The main goal is to evaluate the effectiveness, safety, and processing of LAD603 by the body. Participants will receive different doses of LAD603 or a placebo (a harmless, inactive substance) via injection over 28 weeks. This trial may suit adults who have experienced more than 50% scalp hair loss for at least six months but not more than seven years, and who haven't seen significant hair regrowth recently. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Will I have to stop taking my current medications?
The trial protocol mentions a 'washout period' (time without taking certain medications) for some medications, but it doesn't specify which ones. You may need to stop certain medications, so it's best to discuss this with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that LAD603 is being tested for safety in people with alopecia areata, a condition that causes hair loss. Earlier studies found that LAD603 was generally well-tolerated, with most participants not experiencing serious side effects. Common side effects included mild and temporary redness or swelling at the injection site. This trial is in the middle phase of testing, indicating that LAD603 has demonstrated sufficient safety in earlier stages to proceed. However, further research is underway to better understand any potential risks.12345
Why are researchers excited about this trial's treatment?
Unlike traditional treatments for alopecia areata, which often include corticosteroids or topical immunotherapies, LAD603 offers a fresh approach with subcutaneous injections, providing a more targeted delivery method. Researchers are excited about LAD603 because it could potentially offer longer-lasting effects with fewer side effects compared to current options. This investigational drug might work by a novel mechanism, which could address the root cause of hair loss more effectively than existing therapies.
What evidence suggests that LAD603 might be an effective treatment for alopecia areata?
Research shows that LAD603 may help treat severe alopecia areata (AA), a condition causing significant hair loss. This trial will evaluate different doses of LAD603, with participants receiving either Dose A, Dose B, Dose C, or a placebo. Studies have found that LAD603 can be more effective than a placebo in promoting hair regrowth. Early results suggest that LAD603 affects the processes involved in hair growth, leading to better outcomes for patients. It also appears to have manageable side effects, making it a potentially safe choice. Overall, LAD603 has shown promise in early studies, offering hope to those with severe AA.14678
Who Is on the Research Team?
Study Director
Principal Investigator
Almirall, S.A.
Are You a Good Fit for This Trial?
Adults aged 18-65 with severe to very severe alopecia areata, having lost at least 50% of scalp hair for 6 months to 7 years without regrowth. Women of childbearing potential and men must agree to prevent pregnancy during the study.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive LAD603 or placebo via subcutaneous injection from Day 1 up to 28 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- LAD603
Trial Overview
The trial is testing LAD603's effectiveness on adults with alopecia areata compared to a placebo. It will also assess the drug's safety, how it's processed by the body (PK), its effects on immune response (immunogenicity), and biomarkers related to drug action (PD).
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Placebo Group
Participants will receive LAD603 Dose C, SC injection from Day 1 up to 28 weeks.
Participants will receive LAD603 Dose B, SC injection from Day 1 up to 28 weeks.
Participants will receive LAD603 Dose A , Subcutaneous (SC) injection from Day 1 up to 28 weeks.
Participants will receive Placebo for LAD603 SC injection from Day 1 up to 28 weeks.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Almirall, S.A.
Lead Sponsor
Carlos Gallardo Piqué
Almirall, S.A.
Chief Executive Officer since 2023
MS in Industrial Engineering from Universitat Politècnica de Catalunya, MBA from Stanford Graduate School of Business
Mercedes Diz
Almirall, S.A.
Chief Medical Officer since 2023
PhD in Biochemistry
Citations
A Study of LAD603 in Adults With Alopecia Areata
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 ...
2.
trial.medpath.com
trial.medpath.com/clinical-trial/384ff54a7f072783/nct07311564-lad603-efficacy-safety-severe-alopecia-areataA Study of LAD603 in Adults With Alopecia Areata | MedPath
The main aim of the study is to evaluate the effect of LAD603 in adult participants with severe to very severe alopecia areata (AA).
Almirall Advances LAD603 Phase 2 Alopecia Trial, Adding ...
... LAD603 works better than placebo for severe alopecia areata while keeping side effects acceptable. ... LAD603 as differentiated on efficacy ...
A Study of LAD603 in Adults With 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).
LAD603 for 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).
6.
centerwatch.com
centerwatch.com/clinical-trials/listings/NCT07311564/a-study-of-lad603-in-adults-with-alopecia-areataA Study of LAD603 in Adults With 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).
A Phase 2, Randomized, Placebo-controlled, Double-blind ...
The main aim of the study is to evaluate the effect of LAD603 in adult participants with severe to very severe alopecia areata (AA).
Almirall advances LAD603 phase 2 alopecia trial, adding ...
The study's main purpose is treatment: to prove that LAD603 works better than placebo for severe alopecia areata while keeping side effects ...
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