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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 to week 16
Awards & highlights
Study Summary
This trial is testing a new drug for atopic dermatitis to see if it's effective and safe. Patients will take it 2x/day for 16 weeks.
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.Check my eligibility
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.See study design
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 belowSelect...
I weigh more than 40 kg.
Select...
My skin condition covers 10% or more of my body and is moderate to severe.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percent change from Baseline in Eczema Area and Severity Index (EASI) score Week 16.
Secondary outcome measures
Patients achieving 75% reduction in EASI (EASI75) response at Week 16
Patients achieving a score of clear (0) or almost clear (1) and at least a 2-point improvement in Investigator Global Assessment for AD (IGA-AD) at Week 16
Side effects data
From 2022 Phase 2 trial • 202 Patients • NCT0519041938%
Diarrhoea
23%
Nausea
13%
Headache
8%
Abdominal discomfort
6%
Psoriasis
6%
Vomiting
6%
Dizziness
4%
Dyspepsia
4%
Hot flush
4%
Sinus bradycardia
2%
Myocardial Infarction
2%
Frequent bowel movements
2%
Abdominal pain upper
2%
Nasopharyngitis
2%
Fatigue
2%
Decreased appetite
2%
Gastrooesophageal reflux disease
2%
Gastritis
2%
Sciatica
2%
Post herpetic neuralgia
2%
Haematocrit increased
2%
Upper respiratory tract infection
2%
Bronchitis
2%
Gingivitis
2%
Herpes zoster
2%
Pharyngitis
2%
Pyelonephritis
2%
Tonsillitis
2%
Tooth abscess
2%
Malaise
2%
General physical health deterioration
2%
Oedema peripheral
2%
Electrocardiogram abnormal
2%
Blood cholesterol increased
2%
C-reactive protein increased
2%
Mean cell haemoglobin concentration decreased
2%
Mean cell volume 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%
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
Find a Location
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
Eligibility Criteria:
This trial includes the following eligibility 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 have no cancer history, except possibly treated skin cancer.My atopic dermatitis has recently worsened, needing urgent treatment.My eczema has not improved with treatment.I am able to understand and sign the consent form.I weigh more than 40 kg.I have been diagnosed with atopic dermatitis for at least 1 year.I haven't taken antibiotics for an infection in the last 4 weeks.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Orismilast modified release tablets 20 mg BID
- Group 2: Placebo tablets BID
- Group 3: Orismilast modified release tablets 30 mg BID
- Group 4: Orismilast modified release tablets 40 mg BID
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there a plethora of hospitals conducting this medical experiment in the city?
"Currently, 10 different medical centres are recruiting for this trial. These locations include Canoga Park, Miami and Houston as well as others. It is encouraged to choose the closest clinic in order to reduce travel costs associated with participation."
Answered by AI
Are there any opportunities to join this experiment at the present time?
"Affirmative. According to clinicaltrials.gov, this medical trial is actively recruiting patients who were first alerted of its presence on July 11th 2022 and had the most recent updates posted on September 30th 2022. 210 participants are required across 10 different facilities."
Answered by AI
How many subjects are engaging in this medical experiment?
"Affirmative. Records available on clinicaltrials.gov demonstrate that recruitment for this medical study is currently ongoing, with the first post dated July 11th 2022 and last update being September 30th 2022. The trial seeks to enrol 210 participants across 10 distinct sites."
Answered by AI
What effects have been observed from using Orismilast modified release tablets?
"The assessment of the safety profile for Orismilast modified release tablets is a 2. This rating comes from Phase 2 trial data, which has collected evidence that supports its security but not yet for its efficacy."
Answered by AI
Who else is applying?
What state do they live in?
New York
What site did they apply to?
Juva Skin & Laser Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
Recent research and studies
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