Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04478825




Registration number
NCT04478825
Ethics application status
Date submitted
16/07/2020
Date registered
21/07/2020
Date last updated
1/10/2021

Titles & IDs
Public title
Efficacy and Safety of Rectally Administered BBT-401-1S in Subjects With Ulcerative Colitis
Scientific title
An Open Label, Proof of Mechanism Study to Explore the Efficacy and Safety of Rectally Administered BBT-401-1S in Subjects With Ulcerative Colitis
Secondary ID [1] 0 0
BBT401-UC-004
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BBT-401-1S

Experimental: BBT-401-1S - BBT-401-1S, rectal administration


Treatment: Drugs: BBT-401-1S
BBT-401-1S, 8 weeks, once a day
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Endoscopic remission rate
Timepoint [1] 0 0
Day 57
Secondary outcome [1] 0 0
Endoscopic response rate
Timepoint [1] 0 0
Day 57

Eligibility
Key inclusion criteria
- Male or female, of any race, =18 and =60 years of age on Day 1.

- Have been diagnosed with active distal UC for =3 months prior to Day 1, as determined
by clinical and endoscopic evidence and documented in a histopathology evaluation.

- Have UC that is restricted to between the descending colon and the rectum (ie, left
sided distal colitis), with demarcation of the lesion confirmed by endoscopy.

- Have a total Mayo score =6, an endoscopic subscore =2, rectal bleeding subscore =1,
and a stool frequency subscore =1.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Have used any biologics or Janus kinase (JAK) inhibitors including, but not limited
to, anti TNF a biologics or tofacitinib for the treatment of UC.

- Have used any purine analogues (azathioprine, mercaptopurine, or thiopurines) or
immunosuppressants (methotrexate or cyclosporine) for the treatment of UC within 12
weeks or have any history of nonresponse to these medications.

- Have used any rectal therapy for the treatment of UC with exception of rectal
suppository of 5-aminosalicylic acid, or any intravenous corticosteroids within 2
weeks prior to Day 1.

- Have received oral and/or rectal suppository 5-aminosalicylic acid, oral
sulphasalazine, or low-dose oral corticosteroids that have been stable for <4 weeks.
Doses of the drugs must remain stable until the last dose of study drug.

- 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, prior to Day 1.

- Have Crohn's disease, indeterminate colitis, ischaemic colitis, fulminant colitis,
toxic megacolon, chronic pancolitis, 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 or colostomy.

- 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
24/08/2021
Sample size
Target
Accrual to date
Final
2
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Tauranga
Country [2] 0 0
New Zealand
State/province [2] 0 0
Wellington

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bridge Biotherapeutics, Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Covance
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This is an open label, single-arm, proof of mechanism study to explore the efficacy and
safety of rectally administered BBT-401-1S in subjects with ulcerative colitis.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04478825
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04478825