Efficacy and Safety of Oral BT-11 in Ulcerative Colitis

NImmune Biopharma

Status and phase: Completed; Phase 2

Conditions: Ulcerative Colitis

Treatments: Drug: BT-11 (880 mg); Drug: Placebo; Drug: BT-11 (440 mg)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03861143

BT-11-201

Details and patient eligibility

About

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.

Enrollment: 198 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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198 participants in 3 patient groups, including a placebo group

BT-11 low-dose (440 mg)

Experimental group

Description:

Oral, once daily tablet

Treatment:

Drug: BT-11 (440 mg)

BT-11 high-dose (880 mg)

Experimental group

Description:

Oral, once daily tablet

Treatment:

Drug: BT-11 (880 mg)

Placebo

Placebo Comparator group

Description:

Oral, once daily tablet

Treatment:

Drug: Placebo