Efficacy and Safety of BBT-401-1S in Ulcerative Colitis
23. februar 2022 oppdatert av: Bridge Biotherapeutics, Inc.
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
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.
Studieoversikt
Status
Avsluttet
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
16
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
California
-
Sacramento, California, Forente stater, 95821
- Site 03
-
Ventura, California, Forente stater, 93003
- Site 01
-
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Florida
-
Boca Raton, Florida, Forente stater, 33487
- Site 11
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Pembroke Pines, Florida, Forente stater, 33029
- Site 12
-
-
Maryland
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Rockville, Maryland, Forente stater, 20850
- Site 04
-
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Michigan
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Ann Arbor, Michigan, Forente stater, 48109
- Site 10
-
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North Carolina
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Monroe, North Carolina, Forente stater, 28112
- Site 02
-
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Tennessee
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Chattanooga, Tennessee, Forente stater, 37421
- Site 08
-
-
Texas
-
Austin, Texas, Forente stater, 78705
- Site 05
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McAllen, Texas, Forente stater, 78503
- Site 13
-
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Washington
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Seattle, Washington, Forente stater, 98195
- Site 09
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: BBT-401-1S
BBT-401-1S, Oral capsule, QD
|
Total 16 week treatment period: The subject takes BBT-401-1S, QD for the first 12 weeks, then placebo for the last 4 weeks.
|
|
Placebo komparator: Placebo
Placebo, Oral capsule, QD
|
Total 16 week treatment period: The subject takes the placebo, QD for the first 8 weeks, then BBT-401-1S for the last 8 weeks.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change From Baseline in Total Mayo Score
Tidsramme: Week 8
|
The Total Mayo score is an instrument designed to measure disease activity of ulcerative colitis, with scores ranging from 0 to 12 points.
The Total Mayo score consists of 4 subscores( Stool frequency, Rectal bleeding, Findings of endoscopy, Physician global assessment), each graded from 0 to 3 with higher scores indicating more severe disease.
|
Week 8
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change From Baseline in Partial Mayo Score
Tidsramme: Week 8
|
The Partial Mayo score is an instrument designed to measure disease activity of ulcerative colitis, with scores ranging from 0 to 9 points.
The Partial Mayo score consists of 3 subscores( Stool frequency, Rectal bleeding, Physician global assessment), each graded from 0 to 3 with higher scores indicating more severe disease.
|
Week 8
|
|
Change From Baseline in Histologic Assessment of Endoscopic Biopsy
Tidsramme: Week 8
|
Histological assessment of endoscopic biopsy is an appropriate method for evaluating mucosal healing (Carbonnel et al, 1994).
|
Week 8
|
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Change From Baseline in Ulcerative Colitis Endoscopic Index of Severity (0-8)
Tidsramme: Week 8
|
The Ulcerative Colitis Endoscopic Index of Severity (UCEIS) is the first validated index for the assessment of overall endoscopic activity.
The model incorporates the vascular pattern score(0-2), the presence of bleeding score(0-3) and the presence of erosions and ulcers score (0-3).
Higher score of the sum of these subscore indicates more severe disease.
|
Week 8
|
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Number and Severity of TEAEs
Tidsramme: up to 8 weeks after the last dose
|
Treatment Emergent Adverse Event (TEAE) is defined as an adverse event that occurs or worsens on or after the first dose of study drug.
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up to 8 weeks after the last dose
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Plasma Concentration of BBT- 401-1S
Tidsramme: Day 1, Week 4, Week 8
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Analysis of Plasma Pharmacokinetics for BBT- 401 -1S
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Day 1, Week 4, Week 8
|
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Change From Baseline in Concentration of Serum CRP
Tidsramme: Week 8
|
Widely used serum indicator of inflammation in Ulcerative Colitis(UC).
|
Week 8
|
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Change From Baseline in Concentration of Fecal Calprotectin
Tidsramme: Week 8
|
Reliable surrogate marker for disease activity in Ulcerative Colitis (UC).
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Week 8
|
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Change From Baseline in Concentration of Fecal Lactoferrin
Tidsramme: Week 8
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A stool (fecal) test that is used to detect inflammation in the intestines.
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Week 8
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Studierekorddatoer
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Studer hoveddatoer
Studiestart (Faktiske)
22. april 2019
Primær fullføring (Faktiske)
18. mai 2020
Studiet fullført (Faktiske)
31. juli 2020
Datoer for studieregistrering
Først innsendt
7. januar 2019
Først innsendt som oppfylte QC-kriteriene
8. januar 2019
Først lagt ut (Faktiske)
11. januar 2019
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
21. mars 2022
Siste oppdatering sendt inn som oppfylte QC-kriteriene
23. februar 2022
Sist bekreftet
1. februar 2022
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- BBT401-UC-US02
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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