LEO 138559 for Atopic Dermatitis

No longer recruiting at 36 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new injectable medicine, LEO 138559, to determine its effectiveness in treating moderate to severe atopic dermatitis (AD), a skin condition causing itchy and inflamed patches. Participants will receive either the new medicine or a placebo (an injection with no active medicine). The trial lasts up to 36 weeks, including 16 weeks of treatment and regular clinic visits for monitoring. It is ideal for adults who have had AD for at least a year and have not found success with topical treatments or cannot use them. Participants will contribute to researchers' understanding of the new treatment's effectiveness and side effects. As a Phase 2 trial, this 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 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.

Is there any evidence suggesting that LEO 138559 is likely to be safe for humans?

Research has shown that LEO 138559 is generally safe and well-tolerated. Previous studies found no major safety issues. Specifically, when administered by injection every two weeks, LEO 138559 was considered safe, with most participants experiencing no serious side effects. However, individual reactions can vary with any new treatment. Safety checks are crucial in the trial, and participants will receive close monitoring. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for atopic dermatitis?

LEO 138559 is unique because it offers a novel approach to treating moderate to severe atopic dermatitis. Unlike many current options, which often rely on corticosteroids or calcineurin inhibitors, LEO 138559 is administered through injections that may provide targeted action with potentially fewer side effects. Researchers are particularly excited about its potential to offer more effective and longer-lasting relief for patients who struggle with this chronic skin condition.

What evidence suggests that LEO 138559 might be an effective treatment for atopic dermatitis?

Research has shown that LEO 138559, also known as temtokibart, may help treat moderate to severe atopic dermatitis (AD), a type of eczema. In studies, patients experienced a noticeable decrease in eczema severity by Week 16 when given higher doses of the treatment. These improvements continued through Week 32, indicating the treatment's long-lasting effects. The treatment blocks IL-22, a protein that causes inflammation and skin problems in AD. These findings suggest LEO 138559 could effectively reduce symptoms in people with moderate to severe AD. Participants in this trial will receive either LEO 138559 or a placebo to evaluate the treatment's effectiveness. ^{1 6 7 8 9}

Who Is on the Research Team?

Medical Expert

Principal Investigator

LEO Pharma

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• LEO 138559

How Is the Trial Designed?

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

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04922021

NCT04922021 | An Evaluation of LEO 138559 in Adults ... The purpose of the study is to test a new medicine (LEO 138559) given by injection to see if it works to treat AD and what the side effects are.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05923099

NCT05923099 | A Trial to Evaluate the Efficacy and Safety ... The purpose of this trial is to test different doses of the trial medicine (LEO 138559) at treating moderate to severe atopic dermatitis in adults.

3. clinicaltrialsarena.com clinicaltrialsarena.com/news/leo-pharma-phase-iib-trial/

LEO Pharma reports outcomes from Phase IIb trial of atopic ... LEO Pharma has reported positive topline outcomes from the randomised Phase IIb trial of the IL-22 receptor subunit alpha 1 (IL-22RA1) antagonist temtokibart.

4. practicaldermatology.com practicaldermatology.com/news/from-eadv-temtokibart-shows-sustained-efficacy-in-ad-new-delta-teen-data/2483428/

From EADV: Temtokibart Shows Sustained Efficacy in AD Pooled safety data from five delgocitinib trials confirmed consistent safety in adults up to 52 weeks. LEO Pharma announced data from several ...

5. dermatologytimes.com dermatologytimes.com/view/leo-pharma-presents-late-breaking-results-on-temtokibart-for-atopic-dermatitis-at-eadv

LEO Pharma Presents Late-Breaking Results on ... Temtokibart showed significant EASI score reductions at Week 16 for higher doses, with sustained improvements through Week 32, indicating ...

6. withpower.com withpower.com/trial/phase-2-dermatitis-atopic-8-2023-a0a1d

LEO 138559 for Eczema · Info for Participants The research does not provide specific safety data for LEO 138559, but it mentions that in general, active treatments for eczema, like abrocitinib and dupilumab ...

7. s3.eu-central-1.amazonaws.com s3.eu-central-1.amazonaws.com/m-anage.com.storage.eadv/abstracts_congress2023/37334.pdf

Abstract N°: 4607 Efficacy and safety of IL-22RA1 inhibition ... LEO 138559 was well-tolerated with no safety signals observed. LEO 138559 was shown in vitro to not only block IL-22 signaling, but also IL ...

8. dermatologytimes.com dermatologytimes.com/view/investigational-leo-pharma-il-22-receptor-improves-easi-scores-in-ad

Investigational LEO Pharma IL-22 Receptor Improves EASI ... Results demonstrated that LEO 138559 dosed at 450 mg Q2W by subcutaneous injections for 16 weeks had a positive safety profile. LEO 138559 also ...

9. ctv.veeva.com ctv.veeva.com/study/safety-and-tolerability-of-leo-138559-in-healthy-subjects-and-subjects-with-atopic-dermatitis

Safety and Tolerability of LEO 138559 in Healthy Subjects and ... The primary objective of this trial is to investigate the safety and tolerability of LEO 138559 in healthy subjects and subjects with ...