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 : July 23, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Crohn's Disease | Drug: BT-11 1,000 mg Drug: Placebo | Phase 2 |
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 2021 |
Estimated Primary Completion Date : | November 2021 |
Estimated Study Completion Date : | January 2022 |

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). |
- 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
- 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

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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 |
Key Inclusion Criteria:
- Diagnosis of CD for at least 3 months prior to screening.
- 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).
- Maintain Stable doses of concomitant medications for CD for the duration of the trial (if applicable).
- 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.
- Written informed consent must be obtained and documented.
Key Exclusion Criteria:
- Ulcerative colitis; imminent risk of ileo-colectomy
- 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
- Use of apheresis ≤ 2 weeks prior to screening
- Treatment with an immunosuppressant within 25 days prior to randomization
- Current bacterial or parasitic pathogenic enteric infection; live virus vaccination within 12 weeks of screening.

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
Contact: Josep Bassaganya Riera | 5402182232 | jbr@landosbiopharma.com | |
Contact: Jyoti Chauhan | jyoti@landosbiopharma.com |
Study Director: | Jyoti Chauhan | Landos Biopharma Inc. |
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: | July 23, 2020 |
Last Verified: | July 2020 |
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 |
Crohn Disease Inflammatory Bowel Diseases Gastroenteritis |
Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases |