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CompletedNCT03861143Updated Jun 29, 2023Results posted

Efficacy and Safety of Oral BT-11 in Ulcerative Colitis

A Phase 2 interventional study of BT-11 (440 mg) and BT-11 (880 mg) in Ulcerative Colitis, sponsored by NImmune Biopharma. Completed at 16 sites in 5 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-06-29.

Sponsored by NImmune Biopharma · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
198
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Ulcerative Colitis
03

In context

Colitis

1,073 studies on the registry are indexed under Colitis; 131 are open to participants now.

This study's enrollment of 198 is above the median of 60 across 771 interventional studies indexed under Colitis.

Browse Colitis studies →

Lead sponsor

NImmune Biopharma is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
198 participants (actual)

Study arms

  • Experimental
    BT-11 low-dose (440 mg)

    Oral, once daily tablet

    Drug: BT-11 (440 mg)

  • Experimental
    BT-11 high-dose (880 mg)

    Oral, once daily tablet

    Drug: BT-11 (880 mg)

  • Placebo comparator
    Placebo

    Oral, once daily tablet

    Drug: Placebo

Interventions

  • DrugBT-11 (440 mg)

    Oral, once daily tablet

  • DrugBT-11 (880 mg)

    Oral, once daily tablet

  • DrugPlacebo

    Oral, once daily tablet

06

What researchers measure

Primary outcomes

  1. Clinical Remission

    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.

    Time frame: Week 12

07

Results

Posted Nov 3, 2022

Participant flow

Participant flow — Overall Study
MilestoneBT-11 Low-dose (440 mg)BT-11 High-dose (880 mg)Placebo
Started666666
Completed625958
Not completed478

Outcome measures

PrimaryClinical Remission

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.

Time frame:
Week 12
Reported as:
Number · percentage of participants
Clinical Remission
percentage of participantsBT-11 Low-dose (440 mg)BT-11 High-dose (880 mg)Placebo
Clinical Remission30.331.822.7

Adverse events

Collected over 15 months. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
BT-11 Low-dose (440 mg)0/66 (0%)2/66 (3%)23/66 (34.8%)
BT-11 High-dose (880 mg)0/66 (0%)3/66 (4.5%)29/66 (43.9%)
Placebo0/66 (0%)3/66 (4.5%)27/66 (40.9%)
Most frequent serious events
Most frequent serious events
EventBT-11 Low-dose (440 mg)BT-11 High-dose (880 mg)Placebo
Colitis UlcerativeGastrointestinal disorders0/661/661/66
ProctitisGastrointestinal disorders1/660/660/66
AmoebiasisInfections and infestations0/661/660/66
PneumoniaInfections and infestations0/660/661/66
Pneumonia ViralInfections and infestations0/660/661/66
Foot FractureInjury, poisoning and procedural complications1/660/660/66
Coronavirus Test PositiveInvestigations0/661/660/66
Most frequent other events
Most frequent other events
EventBT-11 Low-dose (440 mg)BT-11 High-dose (880 mg)Placebo
OtherGeneral disorders6/668/6613/66
Colitis UlcerativeGastrointestinal disorders10/668/666/66
AnemiaBlood and lymphatic system disorders2/665/660/66
Corona Virus InfectionInfections and infestations1/661/664/66
DiarrheaGastrointestinal disorders3/660/661/66
NauseaGastrointestinal disorders0/663/660/66
Blood Creatine Phosphokinase IncreasedInvestigations1/663/660/66
HeadacheNervous system disorders0/661/663/66

Baseline characteristics

Age, Continuous
Age, Continuous(years)BT-11 Low-dose (440 mg)BT-11 High-dose (880 mg)PlaceboTotal
Mean43.1 ± 14.943.3 ± 14.943.3 ± 14.543.2 ± 14.7
Sex: Female, Male
Sex: Female, Male(Participants)BT-11 Low-dose (440 mg)BT-11 High-dose (880 mg)PlaceboTotal
Female40223193
Male264435105
Race (NIH/OMB)
Race (NIH/OMB)(Participants)BT-11 Low-dose (440 mg)BT-11 High-dose (880 mg)PlaceboTotal
American Indian or Alaska Native1001
Asian0000
Native Hawaiian or Other Pacific Islander0000
Black or African American0123
White656564194
More than one race0000
Unknown or Not Reported0000
08

Study locations

16 sites
  • Axis Clinical Trials
    Los Angeles, California 90036, United States
  • Ventura Clinical Trials
    Ventura, California 93003, United States
  • Clinical Research of California
    Walnut Creek, California 94598, United States
  • Medycal Research Inc.
    Brooksville, Florida 34613, United States
  • Invesclinic.U.S,LLC.FL
    Fort Lauderdale, Florida 33308, United States
  • I.H.S Health LLC
    Kissimmee, Florida 34741, United States
  • Smart Medical Research
    Richmond Hill, New York 11102, United States
  • Invesclinic.U.S,LLC.
    McAllen, Texas 78503, United States
  • Texas Gastroenterology Associates
    Spring, Texas 77386, United States
  • Polyclinic and Daily hospital "Dr Al Tawil"
    Sarajevo, Federation BiH 71000, Bosnia and Herzegovina
  • Cantonal Hospital Zenica, Gastroenterology
    Zenica, 72000, Bosnia and Herzegovina
  • Polyclinic Duvnjak
    Zagreb, 10000, Croatia
  • Centrum Badan Klinicznych PI-House Sp. z o.o.
    Gdańsk, Pomorskie 80546, Poland
  • RIVERM E D Sp. zo.o.
    Poznań, Wielkopolskie 61441, Poland
  • Municipal Non-profit Enterprise "City Outpatient Clinic No 9 of Kharkiv City Council, Surgery department, Kharkiv
    Kharkiv, 61172, Ukraine
  • Multidisciplinary Medical Center of Odesa National Medical University, First Surgery Department ,Odesa National Medical University , Chair of General and Military Surgeon
    Odesa, 65082, Ukraine
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Nov 3, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 29, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03861143
Lead sponsor
NImmune Biopharma
Responsible party
Sponsor
First posted
Mar 4, 2019
Start date
Aug 14, 2019
Primary completion
Dec 10, 2020
Completion
Jun 17, 2021
Results posted
Nov 3, 2022
Last update
Jun 29, 2023

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.

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