LEO 138559 for Eczema

Recruiting at 71 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

262 Participants Needed

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.

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.

What safety data is available for LEO 138559 in treating eczema?

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, have a higher chance of causing treatment-emergent adverse events (side effects) compared to placebo, although these differences were not significant in short-term studies. ^{1 2 3 4 5}

How does the drug LEO 138559 for eczema differ from other treatments?

The drug LEO 138559 is being tested in a clinical trial for eczema, and while specific details about its unique features are not provided, it is compared to a placebo, which is a common method to evaluate the effectiveness of new treatments. This suggests that LEO 138559 may offer a novel approach or mechanism of action compared to existing therapies, but further information is needed to determine its distinct characteristics. ^{1 3 4 6 7}

Research Team

Medical Expert

Principal Investigator

LEO Pharma

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

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

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)

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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 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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

New evidence on the minimal important change (MIC) for the Hand Eczema Severity Index (HECSI). [2021]

2. England pubmed.ncbi.nlm.nih.gov

Safety of topical corticosteroids in atopic eczema: an umbrella review. [2023]

3. England 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. [2021]

4. England 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. [2021]

5. England 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. [2021]

6. England pubmed.ncbi.nlm.nih.gov

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

7. United States pubmed.ncbi.nlm.nih.gov

How Clinically Relevant Are Treatment Comparisons of Topical Calcineurin Inhibitor Trials for Atopic Eczema? [2018]