LEO 138559 for Atopic Dermatitis

Overseen By LEO Pharma A/S

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: LEO Pharma

Must not be taking: Immunosuppressants, Biologics, others

Disqualifiers: Cardiovascular, Respiratory, Hepatic, others

Compensation: Varies

Number of Visits: 8

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how the body processes a new treatment, LEO 138559 (an experimental treatment), and assesses its safety and tolerability in healthy Japanese individuals. Participants will receive a single dose of LEO 138559 or a placebo and will be monitored over several visits. The trial consists of three groups, each receiving different doses of the treatment. Healthy Japanese individuals who have not lived outside Japan for more than ten years and have no significant health issues may be suitable for this trial. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial requires participants to stop taking certain medications, including immunosuppressive or immunomodulating drugs, topical corticosteroids, topical calcineurin inhibitors, and over-the-counter medications or herbal remedies, before joining. Paracetamol/acetaminophen is allowed up to 2 g per day.

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

Research has shown that LEO 138559 has been tested in other studies for treating skin conditions like atopic dermatitis, a type of eczema. These studies found that participants generally tolerated LEO 138559 well, even at different doses. Importantly, side effects did not increase with higher doses. Some participants experienced mild side effects like conjunctivitis, an eye inflammation, but these were uncommon.

The current trial is a Phase 1 study, focusing primarily on safety. This phase tests the treatment in humans for the first time to assess tolerance. Although specific safety data on LEO 138559 in healthy Japanese participants is not yet available, earlier studies in individuals with skin conditions provide some initial reassurance about its safety. However, as with any early-stage trial, unknown risks may exist, and participants are closely monitored for any side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

LEO 138559 is unique because it focuses on targeting specific pathways in the immune system, which could potentially offer a new approach compared to existing treatments for similar conditions. Unlike other treatments that may require oral or intravenous administration, LEO 138559 is administered subcutaneously, which could make it more convenient for patients. Researchers are excited about its potential to provide a different mechanism of action that might offer benefits such as improved safety and tolerability.

What evidence suggests that LEO 138559 could be effective?

Research has shown that LEO 138559 may help treat moderate to severe atopic dermatitis, a type of eczema. One study demonstrated that taking 450 mg every two weeks for 16 weeks improved eczema severity and was safe. This trial will evaluate different doses of LEO 138559, with participants receiving one of three experimental doses or a placebo. LEO Pharma also reported good results from trials with a substance that blocks certain cell receptors related to LEO 138559. These findings suggest that LEO 138559 could be effective, but more studies are needed to confirm this. ^{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

Be born in Japan with parents and grandparents (maternal and paternal) of Japanese descent

Not have lived outside of Japan for more than 10 years at the time of Screening

No significant change in lifestyle since leaving Japan, including diet.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

up to 4 weeks

Treatment

Single treatment with either LEO 138559 or placebo administered subcutaneously up to 3 injections per dosing

Follow-up

Participants are monitored for safety and effectiveness after treatment

85 days

8 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• LEO 138559
• Placebo

How Is the Trial Designed?

Group I: LEO 138559 Dose 3 Experimental Treatment 1 Intervention

LEO 138559 will be administered subcutaneously up to 3 injections per dosing

Group II: LEO 138559 Dose 2 Experimental Treatment 1 Intervention

LEO 138559 will be administered subcutaneously up to 3 injections per dosing

Group III: LEO 138559 Dose 1 Experimental Treatment 1 Intervention

LEO 138559 will be administered subcutaneously up to 3 injections per dosing

Group IV: Placebo Placebo Group 1 Intervention

LEO 138559 placebo will be administered subcutaneously up to 3 injections per dosing

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. 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.

2. 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 ...

3. 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 ...

4. biospace.com biospace.com/press-releases/leo-pharma-announces-positive-topline-phase-2b-results-for-temtokibart-in-moderate-to-severe-atopic-dermatitis

LEO Pharma announces Positive Topline Phase 2b ... Temtokibart achieved positive results for the primary endpoint for the 3 highest doses in a phase 2b clinical trial in adults with ...

5. 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.

6. 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.

7. clinicaltrials.eu clinicaltrials.eu/trial/study-on-the-effects-of-leo-138559-for-adults-with-moderate-to-severe-atopic-dermatitis/

Study on the Effects of LEO 138559 for Adults with ... The purpose of the study is to find out how well LEO138559 works and how safe it is for people with moderate-to-severe atopic dermatitis.

8. 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 was well tolerated across all doses, with no evidence of dose-dependent adverse events. The incidence of conjunctivitis was low, and ...

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

LEO 138559 for Eczema · Info for Participants While TCS may have a higher relative risk of skin thinning compared to topical calcineurin inhibitors, the overall long-term safety data is limited, suggesting ...