Safety and Efficacy of Oral BT-11 in Crohn's Disease Pati... | NCT05057273

Studies
Safety and Efficacy of Oral BT-11 in Crohn's Disease Patients With Moderate to Severe Disease

NCT05057273

Sponsor

NImmune Biopharma

Status

Withdrawn

Last Update Posted

Jun 7, 2023Actual

Enrollment

0Actual

Phase

Phase 2

Conditions

Crohn's Disease

Interventions

BT-11
Active comparator

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2023

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Decision by Landos Biopharma (not related to safety or efficacy)

Expanded Access Info

Start Date

Nov 2021Estimated

Primary Completion Date

Feb 2022Estimated

Completion Date

Feb 2022Estimated

First Submitted Date

Aug 16, 2021

First Submission Date that Met QC Criteria

Sep 16, 2021

First Posted Date

Sep 27, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 6, 2023

Last Update Posted Date

Jun 7, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is a phase 2, randomized, double-blind, multicenter study to assess the therapeutic efficacy, safety, and mechanisms of omilancor (BT-11) in patients with moderate to severe Crohn's Disease (CD).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BT-11 880 mg	Experimental	Oral once daily tablet	Drug: BT-11
Standard of care	Active Comparator	Biologic	Drug: Active comparator

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BT-11	Drug	Oral once daily tablet	BT-11 880 mg
Active comparator

Measure	Description	Time Frame
Biomarkers of reponse		12 weeks

Eligibility Module

Eligibility Criteria

Key Inclusion Criteria:

Male and female subjects age 18 to 75 years, inclusive.
Diagnosis of CD for at least 6 weeks prior to screening
Moderate to severely active CD as defined by all of the following:
- CDAI score of 220-450
- PRO-2 stool frequency (SF) ≥ 4 and/or abdominal pain (AP) ≥ 2
- SES-CD ≥ 6 ( ≥4 for isolated ileitis) scored by a blinded central reader

Key Exclusion Criteria:

Participant has ulcerative colitis
Participant is at imminent risk of ileo-colectomy
Prior enrolment in the current study and had received study treatment.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003424	Crohn Disease

Ancestor Terms

ID	Term
D015212	Inflammatory Bowel Diseases
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided