LEO 138559 for Eczema

No longer recruiting at 77 trial locations

Overseen By Clinical Disclosure

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: LEO Pharma

Must not be taking: Immunosuppressives, Retinoids, Corticosteroids, JAK inhibitors

Disqualifiers: Cancer, Immunodeficiency, Tuberculosis, HIV, others

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

Compensation: Varies

Number of Visits: 9

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the optimal dose of a new medicine, LEO 138559, for treating moderate to severe atopic dermatitis (commonly known as eczema) in adults. Participants will receive one of four different doses or a placebo (a dummy medicine) to identify the most effective option. Individuals who have had eczema for at least a year and have not found success with standard topical treatments may be suitable for this study. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, providing participants an opportunity to contribute to significant advancements in eczema treatment.

Will I have to stop taking my current medications?

The trial requires participants to stop certain medications before starting. Specifically, you must stop systemic immunosuppressive drugs, immunomodulating drugs, retinoids, corticosteroids, or JAK inhibitors at least 28 days before the trial. Topical treatments like corticosteroids and calcineurin inhibitors must be stopped 7 days before the trial.

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

Research shows that LEO 138559 is under study to assess its safety and effectiveness for treating moderate to severe eczema (atopic dermatitis). Specific safety details for LEO 138559 are not yet available, but it is important to note that this is a Phase 2 trial. This phase indicates that the treatment has been tested in people at least once before, primarily for safety. Thus, LEO 138559 has passed some initial safety tests.

Treatments like LEO 138559 aim to manage eczema symptoms while ensuring patient safety. Although detailed information on side effects is not yet available, the trial phase suggests that earlier studies have shown some safety. Participants in this trial will undergo regular check-ups to monitor for any side effects, ensuring close observation. ^{1 2 3 4 5}

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

Researchers are excited about LEO 138559 because it introduces a potentially game-changing approach to treating eczema. Unlike standard treatments like topical steroids or calcineurin inhibitors, which primarily focus on reducing inflammation, LEO 138559 may offer a different mechanism of action. This new treatment could target underlying causes of eczema more effectively, potentially leading to longer-lasting relief and fewer side effects. The excitement also stems from the fact that LEO 138559 is being tested in various dosing regimens, which could optimize its effectiveness and tailor treatments to individual patient needs.

What evidence suggests that this trial's treatments could be effective for eczema?

Research has shown that LEO 138559 may help treat atopic dermatitis, a type of eczema. One study found it significantly improved the Eczema Area and Severity Index, which measures eczema's impact on the skin. Another study demonstrated that LEO 138559 outperformed a placebo by targeting a protein linked to inflammation. These findings suggest LEO 138559 could reduce eczema symptoms. Participants in this trial will receive different dose regimens of LEO 138559 or a placebo to further evaluate its effectiveness. ^{1 2 6 7 8}

Who Is on the Research Team?

Medical Expert

Principal Investigator

LEO Pharma

Are You a Good Fit for This Trial?

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.

Willingness to comply with the clinical trial protocol

My eczema is moderate to severe.

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.

Timeline for a Trial Participant

Screening/Washout

Participants are screened for eligibility to participate in the trial

up to 4 weeks

1 visit (in-person)

Treatment

Participants receive different doses of LEO 138559 or placebo via subcutaneous injection

16 weeks

4 weekly visits, then 6 bi-weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

16 weeks

4 visits (in-person, every 4 weeks)

What Are the Treatments Tested in This Trial?

Interventions

• LEO 138559
• Placebo

Trial Overview 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.

How Is the Trial Designed?

Group I: Dose regimen 4 Experimental Treatment 1 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 3 Experimental Treatment 1 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 2 Experimental Treatment 1 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 1 Experimental Treatment 1 Intervention

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

Group V: Placebo regimen Placebo Group 1 Intervention

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

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

Published Research Related to This Trial

In a network meta-analysis of 19 randomized controlled trials involving systemic therapies for moderate-to-severe atopic dermatitis, upadacitinib 30 mg once daily showed the highest efficacy, with 83.6% of patients achieving a significant improvement in eczema severity (EASI-50 response).

Abrocitinib and dupilumab also demonstrated strong efficacy, particularly in combination therapy, but all active treatments had a higher incidence of treatment-emergent adverse events compared to placebo, with no significant differences in safety among the active treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative efficacy and safety of systemic therapies used in moderate-to-severe atopic dermatitis: a systematic literature review and network meta-analysis. Silverberg, JI., Thyssen, JP., Fahrbach, K., et al.[2021]

Topical corticosteroids (TCS) used for atopic eczema showed no significant increased risk of skin thinning in short-term studies, indicating they are generally safe for use in both adults and children.

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 that intermittent use of TCS is safe but requires further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of topical corticosteroids in atopic eczema: an umbrella review. Axon, E., Chalmers, JR., Santer, M., et al.[2023]

In a systematic review and meta-analysis of 25 clinical trials involving adult atopic dermatitis (AD), the placebo response rates at 12 weeks were found to be 39.9% for EASI50, 20.9% for EASI75, and 9.0% for EASI90, indicating a notable response even without active treatment.

The study revealed that the placebo response in AD patients was significantly higher than that observed in psoriasis patients, highlighting the unique and fluctuating nature of AD and the importance of consistent topical treatment to manage disease severity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Placebo response in phase 2 and 3 trials of systemic and biological therapies for atopic dermatitis-a systematic review and meta-analysis. Andreasen, TH., Christensen, MO., Halling, AS., et al.[2021]

In a study of 23 patients with severe refractory atopic dermatitis, treatment with Sandimmun Neoral at a dose of 3 mg/kg per day resulted in significant improvements, with the SCORAD index decreasing by 82% after full-dose treatment and 90% after half-dose treatment, indicating strong efficacy.

The treatment was well-tolerated, with no serious adverse events leading to dose reduction or withdrawal, and 91% of patients rated tolerability as very good or good, although some mild side effects like nausea and hirsutism were reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy, tolerability and safety of a new oral formulation of Sandimmun--Sandimmun Neoral in severe refractory atopic dermatitis. Atakan, N., Erdem, C.[2013]

In a study of 152 patients with hand eczema, an improvement of 8.3 points on the Hand Eczema Severity Index (HECSI) was identified as the minimal important change (MIC), which is crucial for evaluating treatment effectiveness.

The study found that the MIC values can vary based on the severity of the eczema at baseline, highlighting the need for further research to clarify these differences in future clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New evidence on the minimal important change (MIC) for the Hand Eczema Severity Index (HECSI). Yüksel, YT., Agner, T., Ofenloch, R.[2021]

The TREAT Registry Taskforce is launching a long-term safety study to compare the safety of dupilumab with other systemic immunomodulating therapies in children and adults with moderate-to-severe atopic eczema, focusing on the incidence of malignancies and other serious adverse events.

This study will utilize a standardized approach across multiple national registries, providing valuable safety data that can inform regulatory bodies, clinicians, and pharmaceutical companies about the long-term risks associated with these therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

TREatment of ATopic eczema (TREAT) Registry Taskforce: protocol for a European safety study of dupilumab and other systemic therapies in patients with atopic eczema. Bosma, AL., Spuls, PI., Garcia-Doval, I., et al.[2021]

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

LEO Pharma reports outcomes from Phase IIb trial of atopic ... The trial achieved positive outcomes in its primary endpoint, showing a significant percentage change in the Eczema Area and Severity Index from ...

3. 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 ...

4. 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.

5. 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 ... Conclusion: In this Phase 2a study, targeting IL-22RA1 with LEO 138559 for 16 weeks improved the signs and symptoms of AD compared to placebo ...

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. ctv.veeva.com ctv.veeva.com/study/a-multi-omics-disease-signature-trial-in-adult-patients-with-moderate-to-severe-ad

A Multi-omics Disease Signature Trial in Adult Patients With ... This clinical trial will investigate the effectiveness and safety of a new active ingredient (LEO 138559) in the treatment of moderate to severe atopic ...

8. 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.