What side effects are associated with this type of intervention?

Common treatments for atopic dermatitis include topical corticosteroids, calcineurin inhibitors (like tacrolimus and pimecrolimus), and PDE4 inhibitors (such as apremilast). Topical corticosteroids can cause skin thinning, stretch marks, and systemic effects if used long-term. Calcineurin inhibitors may lead to burning sensations, itching, and increased risk of skin infections. PDE4 inhibitors, like apremilast, can cause gastrointestinal issues (nausea, diarrhea), headaches, and weight loss. These side effects should be discussed with a healthcare provider to determine the best treatment plan.

What prior FDA approvals exist?

The FDA has approved several treatments for atopic dermatitis, including topical corticosteroids, topical calcineurin inhibitors (such as tacrolimus and pimecrolimus), and biologics like dupilumab. Apremilast, another oral PDE4 inhibitor, has been approved for the treatment of plaque psoriasis and has shown efficacy in nail psoriasis, but it is not specifically approved for atopic dermatitis. Dupilumab, an IL-4 receptor alpha antagonist, is one of the most effective biologics for moderate-to-severe atopic dermatitis. These treatments aim to reduce inflammation and manage symptoms in patients with atopic dermatitis.

What other types of research exist?

Promising novel alternatives to Orismilast Modified Release for Atopic Dermatitis patients include Upadacitinib, Dupilumab, and Abrocitinib. Upadacitinib has shown higher efficacy in achieving EASI-75 and reducing pruritus compared to Dupilumab. Dupilumab has an established safety profile and is effective in both adolescents and adults. Abrocitinib has demonstrated significant efficacy and safety in recent trials, making it a strong candidate for AD treatment.

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Phosphodiesterase 4 (PDE4) inhibitor

Orismilast for Atopic Dermatitis

Phase 2

Waitlist Available

Research Sponsored by UNION therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Body weight of >40 kg

Moderate to severe AD (affected BSA at least 10%, IGA-AD grade of at least 3, and EASI score of at least 16) at the screening and baseline visits

Must not have

Therapy-resistant atopic dermatitis

Unstable AD with acute deterioration, requiring rescue therapy for AD within 4 weeks of the Screening visit or expected to require rescue therapy within 2 weeks after randomization

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 to week 16

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While the side effects of Orismilast are not detailed here, common side effects from similar medications may include gastrointestinal issues like nausea or diarrhea, potential headaches, and possible skin reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I weigh more than 40 kg.

Select...

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My eczema has not improved with treatment.

Select...

My atopic dermatitis has recently worsened, needing urgent treatment.

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 to week 16

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 to week 16

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 to week 16 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percent change from Baseline in Eczema Area and Severity Index (EASI) score Week 16.

Side effects data

From 2022 Phase 2 trial • 202 Patients • NCT05190419

38%

Diarrhoea

23%

Nausea

13%

Headache

Abdominal discomfort

Vomiting

Dizziness

Psoriasis

Sinus bradycardia

Dyspepsia

Hot flush

Pharyngitis

Abdominal pain upper

Frequent bowel movements

Nasopharyngitis

Fatigue

Decreased appetite

Gastrooesophageal reflux disease

Gastritis

Sciatica

Post herpetic neuralgia

Upper respiratory tract infection

Bronchitis

Gingivitis

Herpes zoster

Pyelonephritis

Tonsillitis

Tooth abscess

Malaise

General physical health deterioration

Oedema peripheral

Electrocardiogram abnormal

C-reactive protein increased

Haematocrit increased

Mean cell haemoglobin concentration decreased

Mean cell volume increased

Blood cholesterol increased

Intertrigo

Pruritus

Arthralgia

Back pain

Hypertension

Bundle branch block right

Restlessness

Muscle rupture

Tooth extraction

Wisdom teeth removal

Myocardial Infarction

Seasonal allergy

100%

80%

60%

40%

20%

Study treatment Arm

Placebo Tablets BID

Orismilast Modified Release Tablets 20 mg BID

Orismilast Modified Release Tablets 30 mg BID

Orismilast Modified Release Tablets 40 mg BID

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Orismilast modified release tablets 40 mg BIDExperimental Treatment1 Intervention

Oral, twice daily morning and evening

Group II: Orismilast modified release tablets 30 mg BIDExperimental Treatment1 Intervention

Oral, twice daily morning and evening

Group III: Orismilast modified release tablets 20 mg BIDExperimental Treatment1 Intervention

Oral, twice daily morning and evening

Group IV: Placebo tablets BIDPlacebo Group1 Intervention

Oral, twice daily morning and evening

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Orismilast modified release tablets

2021

Completed Phase 2

~210

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Phosphodiesterase-4 (PDE4) inhibitors, such as Orismilast and Crisaborole, work by reducing inflammation through the inhibition of the PDE4 enzyme, which leads to decreased production of pro-inflammatory cytokines. This is crucial for Atopic Dermatitis (AD) patients as it helps to control the chronic inflammation and pruritus associated with the condition. Topical corticosteroids reduce inflammation and immune responses by suppressing various inflammatory pathways, providing quick relief from symptoms. Calcineurin inhibitors, like tacrolimus and pimecrolimus, inhibit T-cell activation, thereby reducing inflammation and immune responses without the side effects associated with steroids. Biologics, such as dupilumab, target specific molecules involved in the inflammatory process, like the IL-4 and IL-13 pathways, offering a more targeted approach to managing moderate-to-severe AD. These treatments are essential for AD patients as they help manage symptoms, improve quality of life, and reduce the risk of complications associated with chronic inflammation.

The novel protease inhibitor SRD441 ointment is not effective in the treatment of adult subjects with atopic dermatitis: results of a randomized, vehicle-controlled study.