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Anti-inflammatory

An Investigation of Oral BT051 in Subjects With Moderately to Severely Active Ulcerative Colitis (UC) (SCOUT Trial)

Phase 1
Waitlist Available
Research Sponsored by Adiso 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 baseline to days 14 and 28

Summary

This trial tests a new medication called BT051 for people with moderate to severe ulcerative colitis. The goal is to see if it is safe and can help reduce gut inflammation and symptoms. Participants will take the medication daily in different doses for about a month.

Eligible Conditions
  • Colitis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to days 14 and 28
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to days 14 and 28 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Evaluate the safety and tolerability of BT051 based on the difference of proportions between treatment groups of subjects experiencing treatment-emergent adverse events (TEAEs)
Evaluate the safety and tolerability of BT051 based on the difference of proportions between treatment groups of subjects observed with a change from baseline in physical examinations, clinical laboratory tests, vital signs, and electrocardiograms (ECG)
Secondary study objectives
Change in Mayo endoscopic, stool frequency, and rectal bleeding subscores.
Change in Robarts histopathology index (RHI) score
Change in UC-100 score
+10 more
Other study objectives
Area Under the Concentration-Time Curve (AUC) in whole blood
BT051 and BT070 concentrations in stool, colonic tissue, and urine
Maximum observed concentration (Cmax) in whole blood
+2 more

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: BT051 800 mgExperimental Treatment1 Intervention
Participants will receive oral BT051 800 mg once daily for 28 days.
Group II: BT051 3200 mgExperimental Treatment1 Intervention
Participants will receive oral BT051 3200 mg once daily for 28 days.
Group III: BT051 200 mgExperimental Treatment1 Intervention
Participants will receive oral BT051 200 mg once daily for 28 days.
Group IV: PlaceboPlacebo Group1 Intervention
Participants will receive oral Placebo to match BT051 once daily for 28 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BT051 200 mg
2021
Completed Phase 1
~30
BT051 3200 mg
2021
Completed Phase 1
~30
BT051 800 mg
2021
Completed Phase 1
~30

Find a Location

Who is running the clinical trial?

Adiso TherapeuticsLead Sponsor
1 Previous Clinical Trials
36 Total Patients Enrolled
Bacainn Therapeutics, Inc.Lead Sponsor
1 Previous Clinical Trials
50 Total Patients Enrolled
Renu Gupta, MDStudy DirectorAdiso Therapeutics, Inc.
5 Previous Clinical Trials
169 Total Patients Enrolled
Mustafa Noor, MD, FACPStudy DirectorBacainn Therapeutics, Inc.
2 Previous Clinical Trials
336 Total Patients Enrolled
~6 spots leftby Dec 2025
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