Orismilast for Atopic Dermatitis

No longer recruiting at 55 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of different doses of orismilast modified release tablets for individuals with moderate-to-severe atopic dermatitis, a type of eczema that causes itchy and inflamed skin. Participants will take orismilast tablets or a placebo (a pill with no active medicine) twice daily for 16 weeks to assess improvements in their skin condition. The trial also evaluates the treatment's safety. It suits adults who have had atopic dermatitis for at least a year and require more than topical treatments. 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 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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that orismilast, a medication tested for atopic dermatitis (a skin condition causing itchy, inflamed skin), was generally well-tolerated in earlier studies. Most side effects reported were mild, with about 93% falling into this category, while only about 7% were considered moderate. The most common issues involved the digestive system, but they were not severe.

Orismilast has also been studied for other conditions, such as psoriasis. In these studies, it appeared to be a safe oral treatment compared to other similar drugs. Although the current study remains in the early stages, previous research suggests that orismilast is likely safe for most people. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Orismilast for atopic dermatitis because it offers a new approach compared to standard treatments like topical corticosteroids and calcineurin inhibitors. Orismilast is a modified release oral tablet that acts as a PDE4 inhibitor, targeting inflammatory pathways linked to the skin condition. This mechanism may provide a systemic effect, potentially reducing inflammation and itching more effectively than current topical options. Additionally, the modified release formulation ensures steady medication levels in the body, which could lead to more consistent symptom control.

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

Research has shown that orismilast, a type of medication, may help treat atopic dermatitis. One study found that orismilast significantly lowered levels of a substance in the skin linked to inflammation in atopic dermatitis, suggesting it may reduce skin inflammation. Orismilast also improved skin condition in psoriasis, a condition similar to atopic dermatitis. These findings suggest that orismilast could effectively manage moderate-to-severe atopic dermatitis. ^{1 2 5 6 7}

Who Is on the Research Team?

P. A. MD

Principal Investigator

UNION therapeutics A/S

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1.

academic.oup.com

academic.oup.com/bjd/article/192/6/995/7976923

Orismilast, a phosphodiesterase 4B/D inhibitor, in moderate-to ...

The most common TEAEs, reported in ≥ 10% patients in the total orismilast group, were nausea, diarrhoea, vomiting, headache and dizziness.

2.

uniontherapeutics.com

uniontherapeutics.com/union-therapeutics-announce-results-from-the-adesos-phase-2b-study-in-atopic-dermatitis-confirming-the-potential-of-orismilast-as-a-first-in-class-safe-and-efficacious-oral-treatment/

Orismilast Phase 2b results in atopic dermatitis ...

Data showed that TARC skin levels are significantly reduced in the active arms, with end of treatment levels approaching those of non-lesional ...

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39847538/

Orismilast, a phosphodiesterase 4B/D inhibitor, in ...

The primary endpoint was percentage change in Eczema Area and Severity Index (EASI); the secondary endpoints (all at week 16) included ...

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05469464

Study to Assess the Efficacy and Safety of Orismilast in ...

This study investigates 3 different doses of orismilast modified release compared to placebo in adult patients with moderate-to-severe atopic dermatitis.

5.

jaad.org

jaad.org/article/S0190-9622(23)03187-0/fulltext

Orismilast in moderate-to-severe psoriasis: Efficacy and ...

Orismilast showed significant improvements in the primary end point, percentage change in Psoriasis Area and Severity Index (PASI), from ...

6.

onlinelibrary.wiley.com

onlinelibrary.wiley.com/doi/10.1111/jdv.18812

Oral orismilast: Efficacy and safety in moderate‐to‐severe ...

Most AEs in the orismilast MR group were mild (~93%) and 7 were of moderate severity (~7%) (Table S8). The most frequently reported GI-related ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12447663/

Orismilast, a Potent and Selective PDE4B/D Inhibitor ...

Based on these data, orismilast has the potential to be a safe oral drug that provides greater efficacy than less potent pan‐PDE4 inhibitors ...