Orismilast modified release tablets for Skin Diseases

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Rosenpark Research GmbH, Darmstadt, Germany
Skin Diseases+4 More
Orismilast modified release tablets - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This study investigates 3 different doses of orismilast modified release compared to placebo in adult patients with moderate-to-severe atopic dermatitis. The purpose of the study is to assess the effect of orismilast modified release in moderate-to-severe atopic dermatitis and assess the safety aspects of these 3 different doses. The patients will receive an oral treatment of either orismilast modified release tablets or placebo tablets 2 times a day for 16 weeks.

Eligible Conditions

  • Skin Diseases
  • Dermatitis

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Skin Diseases

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: Day 1 to Week 16

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

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Skin Diseases

Trial Design

4 Treatment Groups

Orismilast modified release tablets 20 mg BID
1 of 4
Orismilast modified release tablets 30 mg BID
1 of 4
Orismilast modified release tablets 40 mg BID
1 of 4
Placebo tablets BID
1 of 4
Experimental Treatment
Non-Treatment Group

210 Total Participants · 4 Treatment Groups

Primary Treatment: Orismilast modified release tablets · Has Placebo Group · Phase 2

Orismilast modified release tablets 20 mg BID
Drug
Experimental Group · 1 Intervention: Orismilast modified release tablets · Intervention Types: Drug
Orismilast modified release tablets 30 mg BID
Drug
Experimental Group · 1 Intervention: Orismilast modified release tablets · Intervention Types: Drug
Orismilast modified release tablets 40 mg BID
Drug
Experimental Group · 1 Intervention: Orismilast modified release tablets · Intervention Types: Drug
Placebo tablets BID
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: day 1 to week 16
Closest Location: Excel Clinical Research · Las Vegas, NV
Photo of las vegas 1Photo of las vegas 2Photo of las vegas 3
2010First Recorded Clinical Trial
1 TrialsResearching Skin Diseases
19 CompletedClinical Trials

Who is running the clinical trial?

UNION therapeuticsLead Sponsor
11 Previous Clinical Trials
6,104 Total Patients Enrolled
1 Trials studying Skin Diseases
202 Patients Enrolled for Skin Diseases
P. A. MDStudy DirectorUNION therapeutics A/S

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are male or female.
You have a body weight of >40 kg.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.