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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03870334
Recruitment Status : Not yet recruiting
First Posted : March 12, 2019
Last Update Posted : November 12, 2019
Sponsor:
Information provided by (Responsible Party):
Landos Biopharma Inc.

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 70 sites will participate from Europe and the United States (US).

Condition or disease Intervention/treatment Phase
Crohn's Disease Drug: BT-11 1,000 mg Drug: Placebo Phase 2

Detailed Description:
A total of 130 male and female subjects with moderate to severe CD (CDAI Score 220-450; a patient-reported outcome (PRO-2) stool frequency (SF) score ≥ 4 and/or abdominal pain (AP) ≥ 2, 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 65 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
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 70 sites will participate from Europe and the USA. A total of 130 subjects with moderate to severe CD (CDAI Score 220-450; a patient-reported outcome (PRO-2) stool frequency (SF) score ≥ 4 and/or abdominal pain (AP) ≥ 2, 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 65 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
Official Title: A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacy and Safety of Oral BT-11 in Moderate to Severe Crohn's Disease
Estimated Study Start Date : March 15, 2020
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arm Intervention/treatment
Experimental: BT-11 1,000 mg 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).

Placebo Comparator: 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).




Primary Outcome Measures :
  1. Clinical remission rate [ Time Frame: 12 weeks ]
    Clinical remission defined by CDAI score <150.

  2. 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


Secondary Outcome Measures :
  1. Clinical response [ Time Frame: 12 weeks ]
    Either CDAI < 150 or a CDAI reduction from baseline ≥ 100 points

  2. Change in CDAI [ Time Frame: 12 weeks ]
    Mean change in overall CDAI from baseline to week 12

  3. Endoscopic remission [ Time Frame: 12 weeks ]
    SES-CD ≤ 4, a ≥2-point improvement over baseline, and no sub-score > 1

  4. 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)

  5. 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

  6. Mucosal healing rate [ Time Frame: 12 weeks ]
    Absence of mucosal ulceration



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  1. Diagnosis of CD for at least 3 months prior to screening.
  2. Moderate to severe active CD as defined by a Crohn's Disease Activity Index (CDAI) score of 220 to 450, a patient-reported outcome (PRO-2) stool frequency (SF) score ≥ 4 and/or abdominal pain (AP) ≥ 2, and a simplified Endoscopic Index of Severity for Crohn's Disease (SES-CD) scored ≥ 6 (≥ 4 for isolated ileitis).
  3. Maintain Stable doses of concomitant medications for CD for the duration of the trial (if applicable).
  4. Unlikely to conceive, as defined by 1 of the following: (a) subject is a surgically sterilized female, (b) subject is a postmenopausal female ≥ 45 years of age with clinical documentation of menopause (i.e., 12 months without menses), or (c) subject is male or is a woman of child bearing potential (WOCBP), and agrees to abstain from heterosexual activity, use adequate hormonal contraception, or use double-barrier contraception.
  5. Written informed consent must be obtained and documented.

Key Exclusion Criteria:

  1. Ulcerative colitis; imminent risk of ileo-colectomy
  2. Known or suspected strictures, stenoses, or short gut syndrome; fibrotic disease; current or prior abscesses, unless drained and treated at least 6 weeks before randomization; history of bowel resection or diversion within 6 months prior to screening
  3. Use of apheresis ≤ 2 weeks prior to screening
  4. Treatment with an immunosuppressant within 25 days prior to randomization
  5. Current bacterial or parasitic pathogenic enteric infection; live virus vaccination within 12 weeks of screening.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03870334


Contacts
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Contact: Josep Bassaganya Riera 5402182232 jbr@landosbiopharma.com
Contact: Jyoti Chauhan jyoti@landosbiopharma.com

Sponsors and Collaborators
Landos Biopharma Inc.
Investigators
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Study Director: Jyoti Chauhan Landos Biopharma Inc.

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Responsible Party: Landos Biopharma Inc.
ClinicalTrials.gov Identifier: NCT03870334    
Other Study ID Numbers: BT-11-202
First Posted: March 12, 2019    Key Record Dates
Last Update Posted: November 12, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases