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Phosphodiesterase 4 (PDE4) Inhibitor

Orismilast modified release tablets for Psoriasis (IASOS Trial)

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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 to week 16
Awards & highlights

IASOS Trial Summary

This trial is testing a new drug for plaque psoriasis. It's comparing 3 different doses of the drug to placebo, and looking at safety and effectiveness.

Eligible Conditions
  • Psoriasis
  • Skin Diseases

IASOS Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percent change from Baseline in Psoriasis Activity and Severity Index (PASI) score at Week 16
Secondary outcome measures
Patients achieving 75% reduction in PASI (PASI75) response at Week 16.
Patients achieving a score of Clear (0) or Almost Clear (1) and an at least 2-point improvement in Investigator Global Assessment (IGA) at Week 16.

IASOS 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
6,112 Total Patients Enrolled
P. A., MDStudy DirectorUNION therapeutics A/S

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent could Orismilast modified release tablets be detrimental to human health?

"As the research study is currently in its second phase, there are some safety data available but no efficacy information yet. Therefore, Orismilast modified release tablets was assigned a score of 2."

Answered by AI

Are there numerous sites executing this clinical experiment in the US?

"The Sadick Research Group of New york City, ALLCUTIS in Portsmouth NH, Apex Clinical Research Center near Mayfield Heights OH and 7 other venues are hosting this trial."

Answered by AI

Are there any vacancies available for this clinical experiment?

"According to clinicaltrials.gov, recruitment for this medical trial has been put on hold since it was last updated in 24th August 2022. Nevertheless, there are still 203 other studies actively searching for potential participants presently."

Answered by AI

Who else is applying?

How old are they?
18 - 65
What site did they apply to?
ALLCUTIS Research, LLC
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Study to Assess the Efficacy and Safety of Orismilast in Psoriasis
2021. "Study to Assess the Efficacy and Safety of Orismilast in Psoriasis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05190419.
~62 spots leftby Apr 2025
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