Efficacy and Safety of Oral BT-11 in Moderate to Severe Crohn's Disease
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| ClinicalTrials.gov Identifier: NCT03870334 |
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Recruitment Status :
Recruiting
First Posted : March 12, 2019
Last Update Posted : October 29, 2021
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Sponsor:
Landos Biopharma Inc.
Information provided by (Responsible Party):
Landos Biopharma Inc.
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Crohn's Disease | Drug: BT-11 1,000 mg Drug: Placebo | Phase 2 |
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 : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 150 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 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 Crohn'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 |
| 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 |
| Actual Study Start Date : | May 5, 2021 |
| Estimated Primary Completion Date : | November 2021 |
| Estimated Study Completion Date : | January 2022 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Crohn disease
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 :
- Clinical remission rate [ Time Frame: 12 weeks ]Clinical remission defined by CDAI score <150.
Secondary Outcome Measures :
- 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
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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:
- Subjects aged 18 to 75 years with a diagnosis of CD for at least 3 months;
- 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);
- 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);
- 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:
- Ulcerative colitis;
- Imminent risk of ileocolectomy; symptomatic bowel stricture, ostomy or ileoanal pouch, stenoses, or short gut syndrome;
- Recent (within 2 months) abscess, unless drained and treated at least 6 weeks before randomization;
- History of bowel resection or diversion within 3 months prior to screening;
- Use of apheresis ≤ 2 weeks prior to screening; treatment with an immunosuppressant within 25 days prior to randomization;
- Known 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
| Contact: Josep Bassaganya Riera | 5402182232 | jbr@landosbiopharma.com | |
| Contact: Jyoti Chauhan | jyoti@landosbiopharma.com |
Locations
Show 27 study locations
Sponsors and Collaborators
Landos Biopharma Inc.
Investigators
| 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: | October 29, 2021 |
| Last Verified: | August 2021 |
| 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:
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Crohn Disease Inflammatory Bowel Diseases Gastroenteritis |
Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases |