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Anti-inflammatory agent

LYC-30937-EC 25 mg PO QD for Ulcerative Colitis

Phase 2
Waitlist Available
Research Sponsored by Lycera Corp.
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 10 weeks
Awards & highlights

Summary

The purpose of the study is to evaluate the efficacy and safety of LYC-30937-EC given orally once daily in subjects with active ulcerative colitis (UC) defined as a total Mayo score (TMS) of 4-11 inclusive, with an endoscopic score of ≥ 2 and a rectal bleeding score of ≥ 1 at screening.

Eligible Conditions
  • Ulcerative Colitis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Subjects Who Achieve Clinical Remission at Week 8 Using Modified Mayo Score.
Secondary study objectives
Number of Subjects Who Achieve Clinical Remission at Week 8 Using the Total Mayo Score.
Number of Subjects With a Clinical Response on the Modified Mayo Score at Week 8.
Number of Subjects With a Clinical Response on the Total Mayo Score at Week 8.
+2 more
Other study objectives
Number of Subjects With Type of Adverse Events (AEs) Serious Adverse Events (SAEs) and AEs That Led to Discontinuation of Treatment.

Side effects data

From 2018 Phase 2 trial • 124 Patients • NCT02762500
10%
Headache
6%
Abdominal pain
2%
Adenocarcinoma
100%
80%
60%
40%
20%
0%
Study treatment Arm
LYC-30937-EC 25 mg PO QD
Placebo PO QD

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: LYC-30937-EC 25 mg PO QDExperimental Treatment1 Intervention
LYC-30937-EC 25 mg by mouth once daily for 8 weeks
Group II: Placebo PO QDPlacebo Group1 Intervention
Matching placebo by mouth once daily for 8 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
LYC-30937-EC
2016
Completed Phase 2
~130

Find a Location

Who is running the clinical trial?

Lycera Corp.Lead Sponsor
5 Previous Clinical Trials
287 Total Patients Enrolled
1 Trials studying Ulcerative Colitis
6 Patients Enrolled for Ulcerative Colitis
H. Jeffrey Wilkins, MDStudy DirectorLycera Corp.
1 Previous Clinical Trials
112 Total Patients Enrolled
~14 spots leftby Sep 2025
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