Efficacy and safety of oral BT-11 in moderate to severe Crohn's disease
| ISRCTN | ISRCTN10684113 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10684113 |
| EudraCT/CTIS number | 2019-000824-17 |
| ClinicalTrials.gov number | NCT03870334 |
| Secondary identifying numbers | BT-11-202 |
- Submission date
- 08/07/2021
- Registration date
- 03/08/2021
- Last edited
- 03/08/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English summary of protocol
Background and study aims
Crohn's Disease (CD) is an inflammatory disorder of the intestines that can affect all layers of the bowel walls. As a result of genetic and environmental factors, the cells lining the intestine can become disrupted, causing the immune system to react and damage the tissue. Unlike with normal immune responses, immune responses in CD do not resolve naturally. Therefore, CD patients are treated with steroids, immunosuppressants and biologics that dampen the immune system. However, these treatments do not just affect the digestive system, but also cause many side effects including increased risk of infections and cancers. In addition, current treatments do little to restore the balance in the immune system through regulatory responses, which can naturally counteract damaging inflammatory responses. The main aim of this study is to assess the effectiveness and safety of a new oral treatment BT-11 in mild to moderate CD.
Who can participate?
Patients aged 18 to 75 years with a diagnosis of mild to moderate CD for at least 3 months
What does the study involve?
Participants are randomly allocated to one of two treatment groups (BT-11 or placebo [dummy drug]). After informed consent, all participants undergo an endoscopy, blood tests and other measurements to determine characteristics and severity of disease. If eligible, participants begin 12 weeks of treatment according to the assigned treatment group. At the end of the 12 weeks, participants undergo an endoscopy to observe changes in the health of the colon in addition to changes in biomarkers, histopathology, and patient-reported outcomes, such as stool frequency and rectal bleeding.
What are the possible benefits and risks of participating?
Potential benefits of participation include contributing to the development process in an area of unmet therapeutic need. BT-11 has no known dose-limiting side effects. It may offer an alternative for future patients with CD. BT-11 may decrease the production of inflammatory mediators and increase anti-inflammatory molecules in the digestive tract. Participants in both BT-11 and placebo groups may experience benefit from more frequent assessments by clinical experts for management of CD. To minimize risk, women planning to become pregnant are not eligible for the study and pregnancy tests are performed throughout the study. Endoscopy with biopsy is generally well tolerated as in standard clinical care. However, risks include discomfort, bleeding, or in rare cases perforation.
Where is the study run from?
About 45 sites will participate in Europe and in North America in the following countries: Belarus, Poland, Bosnia and Herzegovina, Croatia, Serbia, Georgia, Ukraine, Hungary, United States of America, Netherlands, Austria, Belgium, Turkey, Czech Republic
When is the study starting and how long is it expected to run for?
April 2021 to January 2022
Who is funding the study?
Landos Biopharma, Inc. (USA)
Who is the main contact?
Jyoti Chauhan, jyoti@landosbiopharma.com
Contact information
Public
Landos Biopharma Inc.
1800 Kraft Drive, Suite 216
Blacksburg
24060
United States of America
| Phone | +1 (0)540 218 1767 |
|---|---|
| jyoti@landosbiopharma.com |
Study information
| Study design | Phase 2 randomized placebo-controlled double-blind parallel-group multicenter induction study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet. |
| Scientific 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 |
| Study acronym | BT-11-202 |
| Study objectives | To evaluate the efficacy and safety of oral BT-11 induction compared to placebo in subjects with moderate to severe CD. |
| Ethics approval(s) | Approved 21/04/2021, Advarra IRB (6940 Columbia Gateway Drive, Suite 110 Columbia, Maryland 21046; +1410-884-2900; Kaitlyn.Halom@advarra.com), ref: BT-11-202 |
| Health condition(s) or problem(s) studied | Crohn's Disease |
| Intervention | Subjects will be randomized to receive BT-11 1,000 mg once-daily or placebo (control) for 12 weeks in the form of an orally swallowed tablet. Patients will be randomized in a 1:1 ratio in a centralized manner, 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). |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | Omilancor (BT-11) |
| Primary outcome measure | Clinical remission rate defined by a CDAI score of <150 measured at 12 weeks using patient records |
| Secondary outcome measures | 1. Clinical response measured by a CDAI reduction from baseline (≥100 points or CDAI <150) at 12 weeks 2. Endoscopic remission measured by SES-CD OF 0-2 or SES-CD ≤4, a ≥2-point improvement over baseline, and no sub-score >1 at 12 weeks 3. Histologic remission measured by Geboes score <2B.1 (with absence of neutrophils in lamina propria) at 12 weeks 4. Endoscopic response measured by SES-CD score (proportion of subjects achieving clinical remission defined as 50% reduction from baseline in SES-CD score at 12 weeks) |
| Overall study start date | 21/04/2021 |
| Completion date | 31/01/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 75 Years |
| Sex | Both |
| Target number of participants | 150 |
| 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 |
| Date of first enrolment | 06/05/2021 |
| Date of final enrolment | 31/10/2021 |
Locations
Countries of recruitment
- Austria
- Belarus
- Belgium
- Bosnia and Herzegovina
- Bulgaria
- Czech Republic
- Netherlands
- Poland
- Serbia
- Slovakia
- Spain
- Türkiye
- Ukraine
- United States of America
Study participating centres
Kissimmee
34741
United States of America
Miami
33165
United States of America
Mission Viejo
92691
United States of America
Glen Burnie
21061
United States of America
Nashville
37232
United States of America
Tampa
33609
United States of America
Crowley
70526
United States of America
Huntsville
35802
United States of America
Austin
78745
United States of America
Tucson
85712
United States of America
Sponsor information
Industry
1800 Kraft Drive
Suite 216
Blacksburg
24060
United States of America
| Phone | +1 540 218 2232 |
|---|---|
| clinical@landosbiopharma.com | |
| Website | http://www.landosbiopharma.com |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 31/01/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The current data sharing plans for this study are unknown and will be available at a later date |
Editorial Notes
14/07/2021: Trial's existence confirmed by Advarra
