LEO 138559 for Eczema

Recruiting in Palo Alto (17 mi)

+71 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: LEO Pharma

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial is testing a new medicine called LEO 138559 to treat adults with moderate to severe atopic dermatitis. The goal is to find out which amount works best to reduce symptoms like itching and redness.

Eligibility Criteria

Adults aged 18-75 with moderate-to-severe atopic dermatitis (eczema) who haven't responded well to typical skin treatments can join. They must have a certain severity of eczema, as measured by specific scales, and be willing to use effective birth control if applicable. People can't participate if they're allergic to trial ingredients, pregnant or breastfeeding, have had the trial drug before, suffer from tuberculosis or cancer (with some exceptions), are at risk of suicide, recently had major surgery or infections.

Inclusion Criteria

My skin condition didn't improve with steroid creams or similar treatments in the last year.

I am between 18 and 75 years old.

Willingness to comply with the clinical trial protocol

+8 more

Exclusion Criteria

I have not had a skin infection in the last week.

I haven't used tanning beds or undergone phototherapy in the last 4 weeks.

I haven't taken any biologic drugs for 3 months or 5 half-lives, whichever is longer.

+28 more

Participant Groups

The study is testing how safe and effective different doses of LEO 138559 are compared to a placebo in treating adult eczema. Participants will receive one of four doses or a dummy injection for up to 16 weeks and will be monitored for another 16 weeks after treatment ends. The medicine is given via injections under the skin at regular clinic visits where their condition and any side effects are checked.

5Treatment groups

Experimental Treatment

Placebo Group

Group I: Dose regimen 4Experimental Treatment1 Intervention

Dose C every week from Week 0 to Week 3, then dose D every 2 weeks from Week 4 to Week 16

Group II: Dose regimen 3Experimental Treatment1 Intervention

Dose A every week from Week 0 to Week 3, then dose C every 2 weeks from Week 4 to Week 16

Group III: Dose regimen 2Experimental Treatment1 Intervention

Dose B every week from Week 0 to Week 3, then every 2 weeks from Week 4 to Week 16

Group IV: Dose regimen 1Experimental Treatment1 Intervention

Dose A every week from Week 0 to Week 3, then every 2 weeks from Week 4 to Week 16

Group V: Placebo regimenPlacebo Group1 Intervention