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Phosphodiesterase 4 (PDE4) inhibitor

Orismilast for Atopic Dermatitis

Warsaw, Poland
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.
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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:
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My eczema has not improved with treatment.
Select...
My atopic dermatitis has recently worsened, needing urgent treatment.
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I have no cancer history, except possibly treated skin cancer.

Timeline

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
8%
Abdominal discomfort
6%
Vomiting
6%
Dizziness
6%
Psoriasis
4%
Sinus bradycardia
4%
Dyspepsia
4%
Hot flush
2%
Pharyngitis
2%
Abdominal pain upper
2%
Frequent bowel movements
2%
Nasopharyngitis
2%
Fatigue
2%
Decreased appetite
2%
Gastrooesophageal reflux disease
2%
Gastritis
2%
Sciatica
2%
Post herpetic neuralgia
2%
Upper respiratory tract infection
2%
Bronchitis
2%
Gingivitis
2%
Herpes zoster
2%
Pyelonephritis
2%
Tonsillitis
2%
Tooth abscess
2%
Malaise
2%
General physical health deterioration
2%
Oedema peripheral
2%
Electrocardiogram abnormal
2%
C-reactive protein increased
2%
Haematocrit increased
2%
Mean cell haemoglobin concentration decreased
2%
Mean cell volume increased
2%
Blood cholesterol increased
2%
Intertrigo
2%
Pruritus
2%
Arthralgia
2%
Back pain
2%
Hypertension
2%
Bundle branch block right
2%
Restlessness
2%
Muscle rupture
2%
Tooth extraction
2%
Wisdom teeth removal
2%
Myocardial Infarction
2%
Seasonal allergy
100%
80%
60%
40%
20%
0%
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

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.

Find a Location

Closest Location:LA Universal Research Center, INC.· Los Angeles, CA

Who is running the clinical trial?

UNION therapeuticsLead Sponsor
11 Previous Clinical Trials
6,104 Total Patients Enrolled
P. A. MDStudy DirectorUNION therapeutics A/S

Media Library

Orismilast modified release tablets (Phosphodiesterase 4 (PDE4) inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05469464 — Phase 2
Atopic Dermatitis Research Study Groups: Orismilast modified release tablets 20 mg BID, Placebo tablets BID, Orismilast modified release tablets 30 mg BID, Orismilast modified release tablets 40 mg BID
Atopic Dermatitis Clinical Trial 2023: Orismilast modified release tablets Highlights & Side Effects. Trial Name: NCT05469464 — Phase 2
Orismilast modified release tablets (Phosphodiesterase 4 (PDE4) inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05469464 — Phase 2
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