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

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

Study Description

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.

Study Design

• 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

Arms and Interventions

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).

Outcome Measures

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

Eligibility Criteria

• 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.

Contacts and Locations

Contacts

Contact: Josep Bassaganya Riera; 5402182232; jbr@landosbiopharma.com

Contact: Jyoti Chauhan; jyoti@landosbiopharma.com

Sponsors and Collaborators

Landos Biopharma Inc.

Investigators

• Study Director: Jyoti Chauhan; Landos Biopharma Inc.

More Information

• Responsible Party: Landos Biopharma Inc.
• ClinicalTrials.gov Identifier: NCT03870334
• Other Study ID Numbers: BT-11-202
• First Posted: March 12, 2019
• Last Update Posted: November 12, 2019
• Last Verified: November 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Crohn Disease; Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases