Efficacy and Safety of BBT-401-1S in Ulcerative Colitis
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| ClinicalTrials.gov Identifier: NCT03800420 |
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Recruitment Status :
Recruiting
First Posted : January 11, 2019
Last Update Posted : October 24, 2019
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Sponsor:
Bridge Biotherapeutics, Inc.
Collaborator:
KCRN Research, LLC
Information provided by (Responsible Party):
Bridge Biotherapeutics, Inc.
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Ulcerative Colitis | Drug: Active group Drug: Placebo group | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 48 participants |
| Allocation: | Randomized |
| Intervention Model: | Sequential Assignment |
| Intervention Model Description: | 'Dose level 1' will be conducted first. 'Dose level 2' and 'Dose level 3' will be started sequentially. Subject will be randomized to active or placebo group in each dose level cohort. |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | April 22, 2019 |
| Estimated Primary Completion Date : | August 1, 2020 |
| Estimated Study Completion Date : | December 15, 2020 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Ulcerative colitis
MedlinePlus related topics:
Ulcerative Colitis
| Arm | Intervention/treatment |
|---|---|
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Experimental: BBT-401-1S, dose level 1
BBT-401-1S or placebo, Oral capsule, QD
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Drug: Active group
BBT-401-1S 12 weeks + Placebo 4 weeks Drug: Placebo group Placebo 8 weeks + BBT-401-1S 8 weeks |
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Experimental: BBT-401-1S, dose level 2
BBT-401-1S or placebo, Oral capsule, QD
|
Drug: Active group
BBT-401-1S 12 weeks + Placebo 4 weeks Drug: Placebo group Placebo 8 weeks + BBT-401-1S 8 weeks |
|
Experimental: BBT-401-1S, dose level 3
BBT-401-1S or placebo, Oral capsule, QD
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Drug: Active group
BBT-401-1S 12 weeks + Placebo 4 weeks Drug: Placebo group Placebo 8 weeks + BBT-401-1S 8 weeks |
Primary Outcome Measures :
- Change from Baseline in Total Mayo Score [ Time Frame: Week 8 ]
Total Mayo Score (0-12): Sum of stool frequency (0-3), rectal bleeding (0-3), endoscopic findings (0-3), physician's global assessment (0-3).
Lower values represent a better outcome.
Secondary Outcome Measures :
- Change from Baseline in Partial Mayo Score [ Time Frame: Week 8 ]
Partial Mayo Score (0-9): Sum of stool frequency (0-3), rectal bleeding (0-3), physician's global assessment (0-3).
Lower values represent a better outcome.
- Change from Baseline in Histologic Assessment of Endoscopic Biopsy [ Time Frame: Week 8 ]Biopsy samples will be assessed in Geboes score (0-6). Lower values represent a better outcome.
- Change from Baseline in Ulcerative Colitis Endoscopic Index of Severity (0-8) [ Time Frame: Week 8 ]Lower values represent a better outcome.
- Number and Severity of TEAEs [ Time Frame: up to 8 weeks after the last dose ]Assess the efficacy and safety of multiple oral doses of BBT-401- 1S in patients with active UC
- Plasma Concentration of BBT- 401-1S [ Time Frame: Day 1, Week 4, Week 8 ]Assess the plasma concentration of multiple oral doses of BBT-401-1S in patients with active UC
- Change from Baseline in Concentration of Serum CRP [ Time Frame: Week 8 ]Evaluate the effects of BBT-401-1S on biomarkers
- Change from Baseline in Concentration of Fecal Calprotectin [ Time Frame: Week 8 ]Evaluate the effects of BBT-401-1S on biomarkers
- Change from Baseline in Concentration of Fecal Lactoferrin [ Time Frame: Week 8 ]Evaluate the effects of BBT-401-1S on biomarkers
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03800420
Contacts
| Contact: Hugh Lee | 240-421-3190 | hughlee@kcrnresearch.com |
Locations
| United States, California | |
| Site 03 | Recruiting |
| Sacramento, California, United States, 95821 | |
| Site 01 | Recruiting |
| Ventura, California, United States, 93003 | |
| United States, Florida | |
| Site 11 | Recruiting |
| Boca Raton, Florida, United States, 33487 | |
| Site 12 | Recruiting |
| Pembroke Pines, Florida, United States, 33029 | |
| United States, Maryland | |
| Site 04 | Recruiting |
| Rockville, Maryland, United States, 20850 | |
| United States, Michigan | |
| Site 10 | Not yet recruiting |
| Ann Arbor, Michigan, United States, 48109 | |
| United States, North Carolina | |
| Site 02 | Recruiting |
| Monroe, North Carolina, United States, 28112 | |
| United States, Tennessee | |
| Site 08 | Recruiting |
| Chattanooga, Tennessee, United States, 37421 | |
| United States, Texas | |
| Site 05 | Recruiting |
| Austin, Texas, United States, 78705 | |
| Site 13 | Recruiting |
| McAllen, Texas, United States, 78503 | |
| United States, Washington | |
| Site 09 | Not yet recruiting |
| Seattle, Washington, United States, 98195 | |
Sponsors and Collaborators
Bridge Biotherapeutics, Inc.
KCRN Research, LLC
Investigators
| Study Director: | Jeong-Hyun Ryou, M.D., Ph.D. | Bridge Biotherapeutics, Inc. |
| Responsible Party: | Bridge Biotherapeutics, Inc. |
| ClinicalTrials.gov Identifier: | NCT03800420 |
| Other Study ID Numbers: |
BBT401-UC-US02 |
| First Posted: | January 11, 2019 Key Record Dates |
| Last Update Posted: | October 24, 2019 |
| Last Verified: | October 2019 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Bridge Biotherapeutics, Inc.:
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Pellino-1 |
Additional relevant MeSH terms:
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Colitis Colitis, Ulcerative Ulcer Gastroenteritis Gastrointestinal Diseases |
Digestive System Diseases Colonic Diseases Intestinal Diseases Pathologic Processes Inflammatory Bowel Diseases |