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Double-Blind 0.2mg CBP-307 for Ulcerative Colitis

Phase 2
Waitlist Available
Research Sponsored by Suzhou Connect Biopharmaceuticals, Ltd.
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 the adapted mayo score was evaluated at screening and week 12 (or early termination visit) during the study stage 1 as well as at week 24 (only for the sub-study 2) and week 48 (or early termination visit) during the study stage 2.
Awards & highlights

Study Summary

This trial will test whether a new drug, CBP-307, is effective and safe for people with moderate to severe ulcerative colitis.

Eligible Conditions
  • Ulcerative Colitis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the adapted mayo score was evaluated at screening and week 12 (or early termination visit) during the study stage 1 as well as at week 24 (only for the sub-study 2) and week 48 (or early termination visit) during the study stage 2.
This trial's timeline: 3 weeks for screening, Varies for treatment, and the adapted mayo score was evaluated at screening and week 12 (or early termination visit) during the study stage 1 as well as at week 24 (only for the sub-study 2) and week 48 (or early termination visit) during the study stage 2. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change From Baseline for Adapted Mayo Score: 0.2 mg Versus Placebo
Secondary outcome measures
Change From Baseline in Adapted Mayo Score: 0.1 mg Versus Placebo
Change in Complete Mayo Score From Baseline
Comparison of Clinical Remission Rate by Adapted Mayo Score
+7 more

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Open-Label CBP-307Experimental Treatment1 Intervention
0.2 mg CBP-307 capsules oral administration.
Group II: Double-Blind 0.2mg CBP-307Experimental Treatment1 Intervention
0.2 mg CBP-307 capsules oral administration.
Group III: Double-Blind 0.1mg CBP-307Experimental Treatment1 Intervention
0.1 mg CBP-307 capsules oral administration.
Group IV: Double-Blind PlaceboPlacebo Group1 Intervention
Placebo capsules oral administration.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Double-Blind 0.2mg CBP-307
2019
Completed Phase 2
~150
Open-label CBP-307
2019
Completed Phase 2
~150
Double-Blind 0.1mg CBP-307
2019
Completed Phase 2
~150

Find a Location

Who is running the clinical trial?

Suzhou Connect Biopharmaceuticals, Ltd.Lead Sponsor
10 Previous Clinical Trials
1,784 Total Patients Enrolled
Suzhou ConnectStudy DirectorSuzhou Connect Biopharmaceuticals, Ltd.
10 Previous Clinical Trials
1,794 Total Patients Enrolled

Frequently Asked Questions

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

Is there an opportunity to be involved in this scientific investigation?

"Qualified candidates for this trial must be aged 18-75, have been diagnosed with an ulcer at least three months prior to screening, and demonstrate moderate to severe active UC based on the adapted Mayo score and endoscopic subscore. Additionally, they must use highly effective contraception during the study period as well as four weeks after their last dose of medication. Participants can also receive oral or IV corticosteroids before randomization if they have taken them continuously at a stable dosage for 4 weeks leading up to enrollment. Lastly, any concomitant medications used in the 7 days preceding first dose of investigational product must remain unchanged throughout the duration"

Answered by AI

Is the elderly population being considered for enrollment in this investigation?

"This medical trial is accepting volunteers of legal age (18+) and below the maximum cut-off of 75 years old."

Answered by AI

Are there any open enrollment opportunities for this research endeavor?

"This research study is not currently recruiting, as indicated by clinicaltrials.gov information; the trial was initially posted on February 27th 2019 and last modified April 20th 2022. Despite this, there are 397 other trials that have open enrollment right now."

Answered by AI

How many healthcare institutions are currently administering this trial?

"Presently, this research project is taking place at 14 locations. The trial sites are located in Homestead, Hialeah and Mission Hills as well as 11 other areas. To reduce the burden of travel associated with enrolling in a clinical trial, it may be wise to select the closest available location for participation."

Answered by AI

What deleterious effects have been observed from CBP-307 usage?

"Our team's assessment of the safety profile of CBP-307 is a 2, given that this Phase 2 trial has collected evidence in support of its security but not yet on efficacy."

Answered by AI
~24 spots leftby Apr 2025