Clinical trial NCT04596293: Efficacy and Safety of Orally Administered BBT-401-1S in Subjects With Ulcerative Colitis
Official title: A Randomised, Double-blind, Placebo-controlled Study of Orally Administered BBT-401-1S in Subjects With Moderate to Severe Ulcerative Colitis, Incorporating a Response-adaptive, Double-blind Extension Phase
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ulcerative Colitis
Lead sponsor: Bridge Biotherapeutics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Covance
First posted: 2020-10-22
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomised, double-blind, placebo-controlled, proof of clinical principle study to explore the efficacy and safety of orally administered BBT-401-1S in subjects with ulcerative colitis.


Eligibility criteria: Inclusion Criteria:

* Male or female, of any race, ≥18 and ≤60 years of age.
* Have been diagnosed with active UC for ≥3 months prior to Day 1, as determined by clinical and endoscopic evidence and documented in a histopathology evaluation.
* Have a total Mayo score ≥6, an endoscopic subscore ≥2, rectal bleeding subscore ≥1, and a stool frequency subscore ≥1, regardless of standard of care history.
* Able to comprehend and willing to voluntarily sign an ICF and to abide by the study restrictions.

Exclusion Criteria:

* Have received:

  1. intravenous corticosteroids, rectally administered corticosteroids, or rectally administered 5-aminosalicylic acid within 3 weeks, or
  2. Janus kinase (JAK) inhibitors within 2 weeks, or
  3. cyclosporine, mycophenolate, tacrolimus, or methotrexate within 5 weeks, or
  4. anti-TNF-α biologics within 9 weeks, or
  5. any other biologics (including ustekinumab and vedolizumab) for the treatment of UC within 12 weeks.
* Have received orally administered azathioprine or 6-mercaptopurine that has been stable for \<8 weeks.
* Have received orally administered 5-aminosalicylic acid, sulphasalazine, or low-dose corticosteroids (prednisolone ≤20 mg/day or equivalent) that have been stable for \<5 weeks.
* Have received any other concomitant medications for UC that have been stable (ie, have not started dosing with a new drug or had a change to their dosing regimen) for \<7 days or 5 half-lives, whichever is longer.
* Have Crohn's disease, indeterminate colitis, ischaemic colitis, fulminant colitis, toxic megacolon, chronic (as determined by the investigator) pancolitis, confined proctitis (distal, ≤15 cm), or symptomatic intestinal stenosis.
* Have a history of extensive colonic resection (subtotal or total colectomy) or are anticipated to require surgical intervention for UC.
* Have an ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine.
* Have a positive test for Clostridium difficile, or have evidence of treatment for Clostridium difficile infection or other pathogenic bowel infection within 60 days or for another intestinal pathogen within 30 days prior to Day 1.

Primary outcomes:
measure: Percentage of Participants Who Achieved a Clinical Response by Total Mayo Score at Day 57
timeFrame: Day 57
Secondary outcomes:
measure: Percentage of Participants Who Achieved a Clinical Remission by Total Mayo Score at Day 57
timeFrame: Day 57
measure: Percentage of Participants Who Achieved an Endoscopic Remission at Day 57
timeFrame: Day 57
measure: Change From Baseline to Day 57 in Total Mayo Score
timeFrame: Baseline, Day 57
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Premier Gastroenterology
state: Arkansas
city: Little Rock
country: United States
facility: Premier Gastroenterology
state: Arkansas
city: Fountain Valley
country: United States
facility: Saini Surinder S MD
state: California
city: Lancaster
country: United States
facility: Gastro Care Institute
state: California
city: Fresh Meadows
country: United States
facility: Intercity Gastroentertology
state: New York
city: Charlotte
country: United States
facility: Javara Research
state: North Carolina
city: McAllen
country: United States
facility: Inves Clinic
state: Texas
city: Pflugerville
country: United States
facility: Discovery Clinical Trials - AACT
state: Texas
city: Riverton
country: United States
facility: Velocity Clinical Research
state: Utah
city: West Jordan
country: United States
facility: West Jordan
state: Utah
city: Haeundae
country: Korea, Republic of
facility: Inje University Haeundae Paik Hospital
state: Busan Gwang'yeogsi
city: Bugok
country: Korea, Republic of
facility: Kyungpook National University Chilgok Hospital
state: Daegu
city: Wŏnju
country: Korea, Republic of
facility: Wonju Severance Christian Hospital
state: Gang'weondo
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Hospital
state: Gwang'yeogsi
city: Ansan
country: Korea, Republic of
facility: Korea University Ansan Hospital
state: Gyeonggido
city: Seocho
country: Korea, Republic of
facility: The Catholic university of Korea, Seoul St Mary's Hospital
state: Seoul Teugbyeolsi
city: Junggu
country: Korea, Republic of
facility: Inje University, Seoul Paik Hospital
state: Seoul
city: Bydgoszcz
country: Poland
facility: Centrum Medyczne Pratia Bydgoszcz
state: Kujawsko-pomorskie,
city: Wrocław
country: Poland
facility: Centrum Medyczne Melita Medical
state: Wroclaw
city: Łódź
country: Poland
facility: Uniwersytecki Szpital Kliniczny Nr. 1 im. Norberta Barlickiego
state: Łódzkie
city: Katowice
country: Poland
facility: VITA LONGA Sp. z o.o.
state: Śląskie
city: Kharkiv
country: Ukraine
facility: Municipal Non-Profit Enterprise City Clinical Hospital No. 2 named after prof. O.O. Shalimov of the
state: Kharkivs'ka Oblast
city: Kherson
country: Ukraine
facility: Municipal Non-Profit Enterprise Kherson City Clinical Hospital named after E.E.Karabelesha of Kherso
state: Khersons'ka Oblast
city: Kyiv
country: Ukraine
facility: Medical Centre of the Limited Liability Company Medical Clinic Blagomed, Treatment and Diagnostic Di
state: Kyïv
city: Kyiv
country: Ukraine
facility: Communal Non-profit enterprise Kyiv City Clinical Hospital No. 18, of the executive body of the Kyiv
state: Kyïv
city: Obukhiv
country: Ukraine
facility: Medical Center RCLIN Ukraine of the Limited Liability Company Cardiocom
state: Kyïv
city: Luts'k
country: Ukraine
facility: Municipal Enterprise Volyn Regional Clinical Hospital of the Volyn Regional Council, Department of S
state: Vinnyts'ka Oblast
city: Vinnytsia
country: Ukraine
facility: Medical Center of LLC Oxford Medical-Vinnytsia
state: Vinnyts'ka Oblast
city: Vinnytsya
country: Ukraine
facility: Communal Non-profit enterprise Vinnytsya city clinical hospital 1 gastroenterology department
state: Vinnyts'ka Oblast
city: Kyiv
country: Ukraine
facility: Municipal Non-Profit Enterprise of the Kyiv Regional Council Kyiv Regional Hospital, Therapeutics De
Study officials:
References: