Clinical trial NCT03861143: Efficacy and Safety of Oral BT-11 in Ulcerative Colitis
Official title: A Randomized , Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacy and Safety of Oral BT-11 in Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ulcerative Colitis
Lead sponsor: NImmune Biopharma
Sponsor class: INDUSTRY
First posted: 2019-03-04
Enrollment: 198
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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 UC. This study includes 3 periods: induction, maintenance, and an optional OLE period.
Primary purpose: TREATMENT

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 UC. This study includes 3 periods: induction, maintenance, and an optional OLE period.


Eligibility criteria: Key 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. . UC, as defined by a total Mayo Score of 4 to 10 inclusive at baseline with a MES 2 (confirmed by central reader).
4. . Able to participate fully in all aspects of this clinical trial.
5. . Written informed consent must be obtained and documented.

Key Exclusion Criteria:

1. . A diagnosis of CD, indeterminate colitis, or presence or history of the fistula with CD.
2. . 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. . Unable to attend study visits or comply with procedures.
6. . Concurrent participation in any other interventional study.
7. . Prior enrollment in the current study and had received study treatment.

Primary outcomes:
measure: Clinical Remission
timeFrame: Week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Axis Clinical Trials
state: California
city: Ventura
country: United States
facility: Ventura Clinical Trials
state: California
city: Walnut Creek
country: United States
facility: Clinical Research of California
state: California
city: Brooksville
country: United States
facility: Medycal Research Inc.
state: Florida
city: Fort Lauderdale
country: United States
facility: Invesclinic.U.S,LLC.FL
state: Florida
city: Kissimmee
country: United States
facility: I.H.S Health LLC
state: Florida
city: Richmond Hill
country: United States
facility: Smart Medical Research
state: New York
city: McAllen
country: United States
facility: Invesclinic.U.S,LLC.
state: Texas
city: Spring
country: United States
facility: Texas Gastroenterology Associates
state: Texas
city: Sarajevo
country: Bosnia and Herzegovina
facility: Polyclinic and Daily hospital "Dr Al Tawil"
state: Federation BiH
city: Zenica
country: Bosnia and Herzegovina
facility: Cantonal Hospital Zenica, Gastroenterology
city: Zagreb
country: Croatia
facility: Polyclinic Duvnjak
city: Gdańsk
country: Poland
facility: Centrum Badan Klinicznych PI-House Sp. z o.o.
state: Pomorskie
city: Poznań
country: Poland
facility: RIVERM E D Sp. zo.o.
state: Wielkopolskie
city: Kharkiv
country: Ukraine
facility: Municipal Non-profit Enterprise "City Outpatient Clinic No 9 of Kharkiv City Council, Surgery department, Kharkiv
city: Odesa
country: Ukraine
facility: Multidisciplinary Medical Center of Odesa National Medical University, First Surgery Department ,Odesa National Medical University , Chair of General and Military Surgeon
Study officials:
References: