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Efficacy and Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis

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ClinicalTrials.gov Identifier: NCT03861143
Recruitment Status : Active, not recruiting
First Posted : March 4, 2019
Last Update Posted : May 6, 2021
Sponsor:
Information provided by (Responsible Party):
Landos Biopharma Inc.

Brief Summary:
This is a phase 2 randomized, placebo-controlled, double-blind, parallel-group multicenter study with an optional open-label extension (OLE) period. The purpose of this study is to evaluate the efficacy and safety of oral BT-11 compared to placebo in subjects with mild to moderate UC. This study includes 3 periods: induction, maintenance, and an optional OLE period.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Drug: BT-11 (500 mg) Drug: BT-11 (1000 mg) Drug: Placebo Phase 2

Detailed Description:
Following a 28-day screening period, a total of 195 subjects with mild to moderate UC (total Mayo Score 4-10; Mayo endoscopic subscore [MES] ≥ 2) are planned to be enrolled into this study from approximately 46 sites in Europe and the United States. Eligible subjects will be randomized in a 1:1:1 ratio to receive BT-11 low-dose (500 mg), BT-11 high-dose (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 UC (yes/no; exposed population limited to 30% of total sample) and corticosteroid use at baseline (yes/no).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 198 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

This is a phase 2 randomized, placebo-controlled, double-blind, parallel-group multicenter study with an optional open label extension (OLE) period. The purpose of this study is to evaluate the efficacy and safety of oral BT-11 compared to placebo in subjects with mild to moderate UC. This study includes 3 periods: induction, maintenance, and an optional OLE period.

Following a 28-day screening period, a total of 195 subjects with mild to moderate UC (total Mayo Score 4-10; Mayo endoscopic subscore [MES] ≥ 2) are planned to be enrolled into this study from approximately 46 sites in Europe and the United States. Eligible subjects will be randomized in a 1:1:1 ratio to receive BT-11 low-dose (500 mg), BT-11 high-dose (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 UC (yes/no; exposed population limited to 30% of total sample) and corticosteroid use at baseline (yes/no).

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 Mild to Moderate Ulcerative Colitis
Actual Study Start Date : August 14, 2019
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BT-11 low-dose (500 mg)
Oral
Drug: BT-11 (500 mg)
Subjects will be randomized to receive BT-11 low-dose (500 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 (high-dose BT-11, low-dose BT-11, or placebo).

Experimental: BT-11 high-dose (1,000 mg)
Oral
Drug: BT-11 (1000 mg)
Subjects will be randomized to receive BT-11 low-dose (1000 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 (high-dose BT-11, low-dose BT-11, or placebo).

Placebo Comparator: Placebo
Oral
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 (high-dose BT-11, low-dose BT-11, or placebo).




Primary Outcome Measures :
  1. Clinical remission rate [ Time Frame: 12 weeks ]
    Clinical remission rate at Week 12, defined using the 3-component modified Mayo Score as a rectal bleeding subscore of 0, a stool frequency subscore of 0 or 1, and an endoscopic subscore of 0 or 1


Secondary Outcome Measures :
  1. Endoscopic remission rate [ Time Frame: 12 weeks ]
    Mayo endoscopic subscore [MES] of 0 or 1

  2. Mucosal healing rate [ Time Frame: 12 weeks ]
    MES of 0 or 1 and a Geboes Histologic Index score of less than 3.1

  3. Mean change in fecal calprotectin from baseline [ Time Frame: up to 12 weeks ]
  4. Concentration of BT-11 in feces [ Time Frame: up to 12 weeks ]
  5. Number of participants with treatment-related adverse events [ Time Frame: up to 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. . Male and female subjects aged 18 to 75 years, inclusive.
  2. . Diagnosis of UC for at least 3 months prior to screening.
  3. . Mild to moderate UC, as defined by a total Mayo Score of 4 to I 0 inclusive at baseline with a MES 2 (confirmed by central reader).
  4. . If subjects have previously received biologic therapy for UC (i.e., tumor necrosis factor [TNF] antagonists, vedolizumab or ustekinumab), they must have a washout period of 8 weeks prior to randomization, and any previous failure of biologic treatment is limited to only one class of biologic. (Note: this inclusion criterion is only applicable until 58 subjects with prior exposure to biologic therapy have been randomized).
  5. . If subjects are receiving the following UC treatments, they must be on a stable dose for at least I month prior to random ization: 5- aminosal icylates (5-ASAs) (not exceed i ng 4.8 g per day), oral corticosteroids (not exceeding prednison e 20 mg, budesonide 9 mg, or equivalent).
  6. . If subjects are receiving bile-salt sequestrant, they must be on a stable dose for at least 3 months prior to randomization.
  7. . If subjects are receiving any non-prohibited medications, they must agree to maintain stable doses of concomitant medication s for UC for the duration of the trial.
  8. . Unlikely to conceive, as defined by 1 of the following: a) subject is surgically sterilized female, (b) subject is postmenopausal female 2: 45 years of age with clinical documentation of menopause (i.e., 12 months without menses), or c) matter is male or subject is woman of childbearing potential (WOCBP), and agrees to abstain from heterosexual activity, use adequate hormonal contraception, or use double barrier contraception.
  9. . For WOCBP, the subject must have a negative pregnancy test at screening and within 24 hours prior to the first dose of study drug.
  10. . Able to participate fully in all aspects of this clinical trial.
  11. . Written informed consent must be obtained and documented.

Exclusion Criteria:

  1. ). A diagnosis of CD, indeterminate colitis, or presence or history of the fistula with CD.

(2). Severe UC as per modified Truelove and Witts criteria (2: 6 bloody stools per day and one or more of the following: pulse > 90 bpm, temperature > 37.8°C, hemoglobin < 10.5 g/dl, or hs-CRP > 30 mg/I).

(3). Disease activity limited to distal 15 cm (proctitis).

(4). Treatment with an immunosuppressant (azathioprine, 6- mercaptopurine [6-MP]) within 25 days prior to randomization.

(5). History of toxic megacolon, abdominal abscess, symptomatic colonic stricture, or stoma; history or is at imminent risk of colectomy.

(6). History or current evidence of colonic dysplasia or adenomatous colonic polyps.

(7). Current bacterial or parasitic pathogenic enteric infection, including Clostridium, d difficult, known infection with hepatitis B or C virus, known infection with human immunodeficiency virus, infection requiring hospitalization or intravenous s antimicrobial therapy, or opportunistic infection within 6 months prior to screening, any infection requiring antimicrobial therapy within 2 weeks prior to screening, history of more than I episode of herpes zoster or any episode of disseminated zoster.

(8). Live virus vaccination within 1 month prior to screening.

(9). Treatment with cyclosporine, mycophenolate, tacrolimus, or tofacitinib within 4 weeks prior to randomization.

(10). Treatment with intravenous corticosteroids, rectal corticosteroids, or rectal 5-ASA within 2 weeks prior to randomization.

(11). Fecal microbiota transplantation within 1 month prior to screening.

(12). A concurrent clinically significant, unstable, or uncontrolled cardiovascular, pulmonary, hepatic, renal, Gl, genitourinary, hematological, coagulation, immunological, endocrine/metabolic, or other medical disorder that, in the opinion of the investigator, might confound the study results or poses additional risk to the subject.

(13). Known primary or secondary immunodeficiency.

(14). History of myocardial infarction, unstable angina, transient ischemic attack, decompensated heart failure requiring hospitalization, congestive heart failure (New York Health Association [NYHA] Class 3 or 4), uncontrolled arrhythmias, cardiac revascularization, stroke, uncontrolled hypertension, or uncontrolled diabetes within 6 months of screening.

(15). Laboratory abnormalities at screening, as determined and documented by the investigator.

(16). Pregnant or lactating females.

(17). Any surgical procedure anesthesia within I month prior to screening, or planned elective surgery during the study.

(18). History of malignant neoplasms or carcinoma in situ within 5 years prior to screening.

(19). Current or recent history of alcohol dependence or illicit drug use that in the opinion of the investigator may interfere with the subject's ability to comply with the study procedures.

(20). Mental or legal incapacitation at the time of screening visit or a history of clinically significant psychiatric disorders that would impact the ability to participate in the trial according to the investigator.

(21). Unable to attend study visits or comply with procedures.

(22). Concurrent participation in any other interventional study.

(23). Received any investigational therapy within 30 days of initiation of study drug.

(24). Serious underlying disease other than UC that in the opinion of the investigator may interfere with the subject's ability to participate fully in the study.

(25). Previous exposure to BT-11.

(26). Prior enrollment in the current study and had received study treatment.


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): NCT03861143


Locations
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United States, California
Axis Clinical Trials
Los Angeles, California, United States, 90036
Ventura Clinical Trials
Ventura, California, United States, 93003
Clinical Research of California
Walnut Creek, California, United States, 94598
United States, Florida
Medycal Research Inc.
Brooksville, Florida, United States, 34613
Invesclinic.U.S,LLC.FL
Fort Lauderdale, Florida, United States, 33308
I.H.S Health LLC
Kissimmee, Florida, United States, 34741
United States, New York
Smart Medical Research
Richmond Hill, New York, United States, 11102
United States, Texas
Invesclinic.U.S,LLC.
McAllen, Texas, United States, 78503
Texas Gastroenterology Associates
Spring, Texas, United States, 77386
Bosnia and Herzegovina
Polyclinic and Daily hospital "Dr Al Tawil"
Sarajevo, Federation BiH, Bosnia and Herzegovina, 71000
Cantonal Hospital Zenica, Gastroenterology
Zenica, Bosnia and Herzegovina, 72000
Croatia
Polyclinic Duvnjak
Zagreb, Croatia, 10000
Poland
Centrum Badan Klinicznych PI-House Sp. z o.o.
Gdańsk, Pomorskie, Poland, 80546
RIVERM E D Sp. zo.o.
Poznań, Wielkopolskie, Poland, 61441
Ukraine
Municipal Non-profit Enterprise "City Outpatient Clinic No 9 of Kharkiv City Council, Surgery department, Kharkiv
Kharkiv, Ukraine, 61172
Multidisciplinary Medical Center of Odesa National Medical University, First Surgery Department ,Odesa National Medical University , Chair of General and Military Surgeon
Odesa, Ukraine, 65082
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: NCT03861143    
Other Study ID Numbers: BT-11-201
First Posted: March 4, 2019    Key Record Dates
Last Update Posted: May 6, 2021
Last Verified: January 2021
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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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases