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A Study Evaluating the Efficacy and Safety of ST-0529 in Subjects With Moderately to Severely Active Ulcerative Colitis

NCT03844932 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 235

Last updated 2021-05-07

No results posted yet for this study

Summary

Study CYC-202 is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of ST-0529 in subjects with moderately to severely active UC, defined as a score of 5 to 9 on the 3-Component Adapted Mayo Score (comprised of rectal bleeding, stool frequency and endoscopy sub-scores; score range 0-9).

Conditions

  • Colitis, Ulcerative

Interventions

DRUG

ST-0529

ST-0529 utilizes SmPill® technology to encapsulate the otherwise insoluble cyclosporine in a presolubilized, lipid-based formulation.

Sponsors & Collaborators

  • Dr. Falk Pharma GmbH

    collaborator INDUSTRY

  • Sublimity Therapeutics Holdco Limited

    lead INDUSTRY

Principal Investigators

  • Sponsor Responsible Medical Officer · Sublimity Therapeutics (HoldCo) Ltd

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-24
Primary Completion
2021-04-14
Completion
2021-04-14
FDA Drug
Yes

Countries

  • United States
  • Belarus
  • Bulgaria
  • Canada
  • France
  • Germany
  • Hungary
  • Ireland
  • Israel
  • Italy
  • Poland
  • Romania
  • Russia
  • Serbia
  • Spain
  • Ukraine
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03844932 on ClinicalTrials.gov