Clinical trial NCT03800420: Efficacy and Safety of BBT-401-1S in Ulcerative Colitis
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2a Study to Evaluate the Efficacy and Safety of BBT-401-1S in Patients With Active Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Ulcerative Colitis
Keywords: Pellino-1
Lead sponsor: Bridge Biotherapeutics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: KCRN Research, LLC
First posted: 2019-01-11
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is randomized, placebo-controlled, dose-escalation, multicenter, Phase 2 study to evaluate the efficacy and safety of BBT-401-1S in patients with active ulcerative colitis.

This study consists of three cohorts with 16-week treatment period per cohort that will be conducted sequentially.


Eligibility criteria: Inclusion Criteria:

* Provision of signed and dated informed consent form (ICF)
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Male or female, aged \>=18 years
* Diagnosed with active UC for at least 3 months prior to screening
* Total Mayo score \>=5 and Endoscopic sub-score \>=1
* Stable dosing regimens of oral drugs (if currently administered) as follows: 5-ASA or sulfasalazine at a stable dose for at least 4 weeks, purine analogues (azathioprine, mercaptopurine, thiopurines) or methotrexate at a stable dose for at least 12 weeks, and low-dose oral corticosteroid (up to 20 mg prednisone/day or equivalent) for at least 4 weeks prior to the first dose of study treatment. Doses of oral drugs must remain stable until the end of study treatment (with possible exception for tapering steroid dose after 8 weeks)
* For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 3 months after the last dose
* For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner during study participation and for an additional 3 months after the last dose

Exclusion Criteria:

* Use of anti-TNF-a biologics or any other biologics for treatment of UC within 60 days prior to randomization.
* Any rectal therapy for treatment of UC or intravenous corticosteroids within 2 weeks prior to randomization.
* Presence of Crohn's disease, indeterminate colitis, ischemic colitis, fulminant colitis, ulcerative proctitis, or toxic mega-colon
* Previous extensive colonic resection (subtotal or total colectomy)
* Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine
* Evidence of or treatment for Clostridium difficile infection or other pathogenic bowel infection within 60 days or for another intestinal pathogen within 30 days prior to randomization
* Active infection with the HIV or Hepatitis B or C viruses
* Clinically significant active extra-intestinal infection (e.g., pneumonia, pyelonephritis)
* Clinically significant abnormal vital signs, physical examination or 12-lead electrocardiogram (ECG) at screening or baseline
* Clinically significant abnormal results of liver function tests (ALT/AST, bilirubin and alkaline phosphatase) \> 2X the upper limit of normal (ULN) at screening
* Other clinically significant abnormal laboratory results at screening in the investigator's opinion
* History of any clinically significant medical condition that, in the investigator's opinion, would preclude participation in the study
* Pregnancy or lactation
* Treatment with another investigational drug or other intervention within 30 days prior to screening

Primary outcomes:
measure: Change From Baseline in Total Mayo Score
timeFrame: Week 8
Secondary outcomes:
measure: Change From Baseline in Partial Mayo Score
timeFrame: Week 8
measure: Change From Baseline in Histologic Assessment of Endoscopic Biopsy
timeFrame: Week 8
measure: Change From Baseline in Ulcerative Colitis Endoscopic Index of Severity (0-8)
timeFrame: Week 8
measure: Number and Severity of TEAEs
timeFrame: up to 8 weeks after the last dose
measure: Plasma Concentration of BBT- 401-1S
timeFrame: Day 1, Week 4, Week 8
measure: Change From Baseline in Concentration of Serum CRP
timeFrame: Week 8
measure: Change From Baseline in Concentration of Fecal Calprotectin
timeFrame: Week 8
measure: Change From Baseline in Concentration of Fecal Lactoferrin
timeFrame: Week 8
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Site 03
state: California
city: Ventura
country: United States
facility: Site 01
state: California
city: Boca Raton
country: United States
facility: Site 11
state: Florida
city: Pembroke Pines
country: United States
facility: Site 12
state: Florida
city: Rockville
country: United States
facility: Site 04
state: Maryland
city: Ann Arbor
country: United States
facility: Site 10
state: Michigan
city: Monroe
country: United States
facility: Site 02
state: North Carolina
city: Chattanooga
country: United States
facility: Site 08
state: Tennessee
city: Austin
country: United States
facility: Site 05
state: Texas
city: McAllen
country: United States
facility: Site 13
state: Texas
city: Seattle
country: United States
facility: Site 09
state: Washington
Study officials:
References: