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

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ClinicalTrials.gov Identifier: NCT03870334
Recruitment Status : Not yet recruiting
First Posted : March 12, 2019
Last Update Posted : May 6, 2021
Sponsor:
Information provided by (Responsible Party):
Landos Biopharma Inc.

Tracking Information
First Submitted Date  ICMJE March 8, 2019
First Posted Date  ICMJE March 12, 2019
Last Update Posted Date May 6, 2021
Estimated Study Start Date  ICMJE May 2021
Estimated Primary Completion Date November 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 10, 2021)
Clinical remission rate [ Time Frame: 12 weeks ]
Clinical remission defined by CDAI score <150.
Original Primary Outcome Measures  ICMJE
 (submitted: March 8, 2019)
  • Clinical remission rate [ Time Frame: 12 weeks ]
    Clinical remission defined by CDAI score <150.
  • Endoscopic response [ Time Frame: 12 weeks ]
    Proportion of subjects with a 50% reduction from baseline in the Simplified Endoscopic Index of Severity for Crohn's Disease (SES-CD) score
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 10, 2021)
  • Clinical response [ Time Frame: 12 weeks ]
    CDAI reduction from baseline ≥ 100 points or CDAI < 150
  • Endoscopic remission [ Time Frame: 12 weeks ]
    SES-CD OF 0-2 or SES-CD ≤ 4, a ≥2-point improvement over baseline, and no sub-score > 1
  • Histologic Remission [ Time Frame: 12 weeks ]
    Geboes score < 2B.1 (with absence of neutrophils in lamina propria)
  • Endoscopic Response [ Time Frame: 12 weeks ]
    Proportion of subjects achieving clinical remission defined as 50% reduction from baseline in SES-CD score at week 12
Original Secondary Outcome Measures  ICMJE
 (submitted: March 8, 2019)
  • Clinical response [ Time Frame: 12 weeks ]
    Either CDAI < 150 or a CDAI reduction from baseline ≥ 100 points
  • Change in CDAI [ Time Frame: 12 weeks ]
    Mean change in overall CDAI from baseline to week 12
  • Endoscopic remission [ Time Frame: 12 weeks ]
    SES-CD ≤ 4, a ≥2-point improvement over baseline, and no sub-score > 1
  • Patient Reported Outcome and Stool Frequency Score [ Time Frame: 12 weeks ]
    PRO-2 AP score of ≤1 and a loose/watery SF score ≤3 (7-day average)
  • Endoscopic Response [ Time Frame: 12 weeks ]
    Proportion of subjects achieving both (a) clinical remission at week 12 defined as a PRO-2 AP score of ≤1 and a loose/watery SF score ≤3 (7-day average), AND (b) a 50% reduction from baseline in SES-CD score at week 12
  • Mucosal healing rate [ Time Frame: 12 weeks ]
    Absence of mucosal ulceration
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Oral BT-11 in Moderate to Severe Crohn's Disease
Official Title  ICMJE A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacy and Safety of Oral BT-11 in Moderate to Severe Crohn's Disease
Brief Summary This is a phase 2 randomized, placebo-controlled, double-blind, parallel-group multicenter induction study. The purpose of this study is to evaluate the efficacy and safety of oral BT-11 induction compared to placebo in subjects with moderate to severe CD. Approximately 100 sites will participate from Europe and the United States.
Detailed Description

A total of 150 subjects will be randomized in a 1:1 ratio, in a centralized manner, to receive BT 11 1000 mg or placebo. Each of the treatment arms will comprise 75 subjects. The randomization will be stratified by prior exposure to biologic therapy for CD (yes/no; exposed population limited to 50% of total sample) and corticosteroid use at baseline (yes/no).

The study will consist of a 28-day screening period, a 12-week induction period, an 18-week maintenance period, and a 2-week posttreatment safety follow-up period.

Subjects who are nonresponders at Week 12, or who lose response during the maintenance period, or who complete the Week 30 study will be eligible for a separate open-label extension (OLE) study.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
This is a phase 2 randomized, placebo-controlled, double-blind, parallel-group multicenter induction study. The purpose of this study is to evaluate the efficacy and safety of oral BT-11 induction compared to placebo in subjects with moderate to severe CD. Approximately 100 sites will participate from Europe and the USA. A total of 150 subjects with moderate to severe CD (CDAI Score 220-450 and a Simplified Endoscopic Index of Severity of Chron's Disease (SES-CD) SCORED ≥ 6 (≥ 4 for isolated ileitis) will be randomized in a 1:1 ratio to receive BT-11 1,000 mg or placebo. Each of the treatment arms will comprise 75 subjects. The randomization will be stratified by prior exposure to biologic therapy for CD (yes/no) and corticosteroid use at baseline (yes/no). The study consists of a 28-day screening period, a 12-week induction phase, and a 2-week post-treatment safety follow-up period.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Crohn's Disease
Intervention  ICMJE
  • Drug: BT-11 1,000 mg
    Subjects will be randomized to receive BT-11 1,000 mg once-daily for 12 weeks. All tablets administered (placebo and BT-11) will have the same appearance and size. Each subject will receive blister packs of the study drug (BT-11, or placebo).
  • Drug: Placebo
    Subjects will be randomized to receive Placebo once daily for 12 weeks. All tablets administered (placebo and BT-11) will have the same appearance and size. Each subject will receive blister packs of the study drug (BT-11, or placebo).
Study Arms  ICMJE
  • Experimental: BT-11 1,000 mg
    Intervention: Drug: BT-11 1,000 mg
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: March 10, 2021)
150
Original Estimated Enrollment  ICMJE
 (submitted: March 8, 2019)
130
Estimated Study Completion Date  ICMJE January 2022
Estimated Primary Completion Date November 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  1. Subjects aged 18 to 75 years with a diagnosis of CD for at least 3 months;
  2. Moderately to severely active CD as defined by: a CDAI score of 220 450, and an SES-CD scored ≥ 6 ( ≥ 4 for isolated ileitis) (centrally read);
  3. Prior biologic must have stopped at least 8 weeks before study (or within 4 weeks prior to randomization, if no detectable drug levels by validated or commercial assay) and previous biologic treatment failure is limited to 1 class of biologic (if applicable);
  4. 5 aminosalicylates (max 4.8 g/day) and oral corticosteroids (max 20 mg/day prednisone or equivalent) must be stable for the duration of the 12-week induction period.

Key exclusion criteria:

  1. Ulcerative colitis;
  2. Imminent risk of ileocolectomy; symptomatic bowel stricture, ostomy or ileoanal pouch, stenoses, or short gut syndrome;
  3. Recent (within 2 months) abscess, unless drained and treated at least 6 weeks before randomization;
  4. History of bowel resection or diversion within 3 months prior to screening;
  5. Use of apheresis ≤ 2 weeks prior to screening; treatment with an immunosuppressant within 25 days prior to randomization;
  6. Known current bacterial or parasitic pathogenic enteric infection; live virus vaccination within 12 weeks of screening.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Josep Bassaganya Riera 5402182232 jbr@landosbiopharma.com
Contact: Jyoti Chauhan jyoti@landosbiopharma.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03870334
Other Study ID Numbers  ICMJE BT-11-202
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Landos Biopharma Inc.
Study Sponsor  ICMJE Landos Biopharma Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Jyoti Chauhan Landos Biopharma Inc.
PRS Account Landos Biopharma Inc.
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP