Orismilast for Atopic Dermatitis

Recruiting at 47 trial locations

Overseen By UNION therapeutics A/S Study Director Study Director

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: UNION therapeutics

Disqualifiers: Therapy-resistant AD, Active infection, Malignancy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

235 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new pill called orismilast, which releases its medicine slowly over time. It aims to help adults with severe atopic dermatitis, a skin condition that causes redness and itching. The pill works by reducing inflammation.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

How is the drug Orismilast unique for treating atopic dermatitis?

Orismilast is unique because it is a modified release tablet, which may offer a different dosing schedule compared to other treatments like topical creams or ointments. This oral administration could provide a more convenient option for patients who prefer not to use topical treatments. ^{1 2 3 4 5}

Research Team

P. A. MD

Principal Investigator

UNION therapeutics A/S

Eligibility Criteria

Adults over 18 with moderate-to-severe atopic dermatitis (eczema) for at least a year, who are candidates for systemic treatment or phototherapy. They must weigh more than 40 kg and have specific severity scores on medical scales. People with allergies to study drugs, history of certain cancers, unstable eczema, or recent infections needing antibiotics can't participate.

Inclusion Criteria

My skin condition covers 10% or more of my body and is moderate to severe.

I am a candidate for systemic treatment or light therapy for my skin condition.

I am able to understand and sign the consent form.

Exclusion Criteria

History of allergy or hypersensitivity to any component of the study treatment

I have no cancer history, except possibly treated skin cancer.

My atopic dermatitis has recently worsened, needing urgent treatment.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive an oral treatment of either orismilast modified release tablets or placebo tablets 2 times a day for 16 weeks

16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Orismilast modified release tablets
• Placebo

Trial Overview The trial is testing three different doses of Orismilast tablets against a placebo in adults with moderate-to-severe atopic dermatitis. Participants will take the oral treatment twice daily for 16 weeks to evaluate its effectiveness and safety.

Participant Groups

Group I: Orismilast modified release tablets 40 mg BID Experimental Treatment 1 Intervention

Oral, twice daily morning and evening

Group II: Orismilast modified release tablets 30 mg BID Experimental Treatment 1 Intervention

Oral, twice daily morning and evening

Group III: Orismilast modified release tablets 20 mg BID Experimental Treatment 1 Intervention

Oral, twice daily morning and evening

Group IV: Placebo tablets BID Placebo Group 1 Intervention

Oral, twice daily morning and evening

Who Is Running the Clinical Trial?

UNION therapeutics

Lead Sponsor

Trials

12

Recruited

6,300+

Findings from Research

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]

Dermacare, a new cosmetic formulation for atopic dermatitis, was found to be safe and well-tolerated in a multicenter study with no reported adverse events, demonstrating its potential for daily use.

After 28 days of treatment, Dermacare significantly reduced skin barrier disruption, as shown by a 70.4% decrease in the Eczema Area and Severity Index and a 36.7% decrease in transepidermal water loss, indicating improved skin condition and quality of life for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New Cosmetic Formulation for the Treatment of Mild to Moderate Infantile Atopic Dermatitis. de Lucas, R., García-Millán, C., Pérez-Davó, A., et al.[2020]

References

1. 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]

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

Topical treatment utilization for patients with atopic dermatitis in the United States, and budget impact analysis of crisaborole ointment, 2. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

New Cosmetic Formulation for the Treatment of Mild to Moderate Infantile Atopic Dermatitis. [2020]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Crisaborole Ointment, 2%, for the Treatment of Mild-to-Moderate Atopic Dermatitis Across Racial and Ethnic Groups. [2021]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Once-Daily Crisaborole Ointment, 2%, as a Long-Term Maintenance Treatment in Patients Aged ≥ 3 Months with Mild-to-Moderate Atopic Dermatitis: A 52-Week Clinical Study. [2023]