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Anti-inflammatory

BT051 200 mg for Ulcerative Colitis (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

Awards & highlights

SCOUT Trial Summary

This trial is testing a new drug, BT051, to see if it is safe and tolerated by people with ulcerative colitis. The trial will have 3 groups of 8 people, with 3 of the people taking BT051 and 1 taking a placebo. The trial will last 28 days.

Eligible Conditions

Ulcerative Colitis

SCOUT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to days 14 and 28

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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 outcome measures

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

SCOUT 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 800 mg

2021

Completed Phase 1

~30

BT051 3200 mg

2021

Completed Phase 1

~30

Do I qualify?Apply below to find out

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

Mustafa Noor, MD, FACPStudy DirectorBacainn Therapeutics, Inc.

2 Previous Clinical Trials

336 Total Patients Enrolled

Frequently Asked Questions

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

Are participants of this clinical trial limited to those under 30 years old?

"This clinical trial is recruiting patients between the ages of 18 and 75. 70 studies are available to those under the age of majority, while 347 can be found for seniors over 65 years old."

Answered by AI

How many people have enrolled in this experiment thus far?

"Affirmative. Clinicaltrials.gov verifies that this trial is presently enrolling patients, with the first post dated 11/30/2021 and a recent update on 10/14/2022. The study requires 44 individuals to be recruited from 2 sites."

Answered by AI

Is this investigation still recruiting participants?

"According to clinicaltrials.gov, the trial launched on November 30th 2021 and has since been updated as recently as October 14 2022 - indicating that it is actively recruiting participants."

Answered by AI

Am I eligible to participate in the current clinical experiment?

"To be accepted into the study, colitis and ulcerative sufferers must fall between 18-75 years old. The trial is currently looking to enrol 44 individuals."

Answered by AI

Has BT051 been formally sanctioned by the FDA at a dosage of 3200 mg?

"With limited clinical data available, BT051 safety up to 3200 mg only earned a score of 1. This is due to it being in the early stages of testing during Phase 1 trials."

Answered by AI

What is the primary objective of this research endeavor?

"The primary metric of success tracked in this trial, measured from Baseline to Day 58, is the safety and tolerability of BT051 as evidenced by a difference between treatment groups' rates of adverse events. Secondary goals include assessing remission on Day 28 based on Mayo Score ≤2 points with no subscore >1 point; clinical response defined as decreasing complete Mayo Score ≥3 points and ≥30% at baseline along with rectal bleeding subscore ≥1 point or absolute rectal bleeding subscore ≤1 point; and proportionally tracking change in stool frequency and rectal bleeding scores compared to their baselines on Day 14."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2021. "An Investigation of Oral BT051 in Subjects With Moderately to Severely Active Ulcerative Colitis (UC)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05084261.