An Evaluation of LEO 138559 in Adults With Moderate to Severe Atopic Dermatitis.

Recruiting at 34 trial locations

Overseen By Clinical Disclosure

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: LEO Pharma

Must not be taking: Immunosuppressives, Biologics, Corticosteroids, others

Disqualifiers: Hepatitis B/C, HIV, Tuberculosis, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

58 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a new injectable medicine, LEO 138559, in adults with moderate to severe atopic dermatitis. The medicine is likely designed to reduce inflammation and help the skin heal. The study will last several months, including a treatment period and a follow-up period to monitor safety.

Will I have to stop taking my current medications?

The trial requires participants to stop taking certain medications before joining. Specifically, you must stop systemic immunosuppressive medications, biologics, and certain topical treatments for a specified period before starting the trial. Please consult with the study team for details on your specific medications.

Research Team

Medical Expert

Principal Investigator

LEO Pharma

Eligibility Criteria

Inclusion Criteria

Diagnosis of atopic dermatitis (AD) (as defined by the American Academy of Dermatology Consensus Criteria) that has been present for ≥1 year prior to screening.

Subjects who have a recent history (within 6 months before screening) of inadequate response to treatment with topical medication, or for whom topical treatments are otherwise medically inadvisable.

Eczema Area and Severity Index (EASI) score ≥12 at screening and ≥16 at baseline.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive injections of LEO 138559 or placebo for 16 weeks

16 weeks

Regular clinic visits for tests and evaluations

Follow-up

Participants are monitored for safety and effectiveness after treatment

16 weeks

Regular clinic visits for safety evaluations

Treatment Details

Interventions

• LEO 138559

Participant Groups

Group I: LEO 138559 Experimental Treatment 1 Intervention

Participants will receive injections of LEO 138559 from Week 0 (baseline) to Week 16 (end of treatment).

Group II: Placebo Placebo Group 1 Intervention

Participants will receive injections of placebo from Week 0 (baseline) to Week 16 (end of treatment).

Who Is Running the Clinical Trial?

LEO Pharma

Lead Sponsor

Trials

275

Recruited

189,000+

Christophe Bourdon

LEO Pharma

Chief Executive Officer since 2022

Engineering degree from Université de Technologie de Compiègne

Dr. Siri Torhaug

LEO Pharma

Chief Medical Officer since 2022

MD, PhD