EUCTR2018-002001-65-GB
Active, not recruiting
Phase 1
A Phase Ib/IIb, Randomised, Double Blind, Placebo-Controlled Trial to Investigate the Safety, Tolerability and Clinical Activity of Humanised Antibody GSK1070806 in the Treatment of Patients with Moderate-to-Severe Crohn’s Disease - CDAID GSK1070806
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Crohn's disease
- Sponsor
- niversity of Birmingham
- Enrollment
- 36
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •A patient will be eligible for inclusion in this study only if all of the following criteria apply:
- •1\.Written informed consent prior to any of the screening procedures including discontinuation of prohibited medications. (see Section 7\.11 for additional information)
- •2\.Patients that have been diagnosed with moderate to severe Crohn’s disease for at least 3 months prior to Screening Visit 1 defined by CDAI score between 220\-450
- •3\.Patients are required to have endoscopic evidence of active Crohn’s disease at Baseline (screening visit 1\) defined by endoscopic appearance: SES\-CD excluding the narrowed component of \= 6 (or \=4 for patients with isolated ileal disease).
- •4\.AST and ALT \= 2xULN; alkaline phosphatase and bilirubin \= 1\.5xULN (isolated bilirubin \>1\.5xULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%)
- •5\.Male or female participants aged \=16 years (up to 80 years)
- •Male participants:
- •6\.A male participant must agree to use contraception as detailed in Appendix 5 of this protocol for at least 180 days post\-dose of study medication and refrain from donating sperm during this period.
- •Female participants:
- •7\.A female participant is eligible to participate if she is not pregnant or breastfeeding and not a woman of childbearing potential (WOCBP) defined as at least one of the following conditions:
Exclusion Criteria
- •A participant will not be eligible for inclusion in this trial if any of the following criteria apply:
- •1\.Diagnosis of ulcerative or indeterminate colitis
- •Crohn’s Disease complications:
- •2\.Evidence of an infected abscess by MRI or other examinations
- •3\.Bowel surgery other than appendectomy within 12 weeks prior to screen and/or has planned surgery or deemed likely to need surgery for CD during the trial period
- •4\.Participants with ileostomies, colostomies or rectal pouches
- •5\.Participants with a bowel stricture that is fixed
- •6\.Participants with evidence of short bowel syndrome
- •7\.Participants requiring enteral or parenteral feeding
- •8\.Deep penetrating ulcers at endoscopy thought to be at risk for perforation
Outcomes
Primary Outcomes
Not specified
Similar Trials
Recruiting
Phase 1
A multiple-ascending dose study of RO7126209 in patients with prodromal or mild to moderate Alzheimer's diseaseAlzheimer's diseaseJPRN-jRCT2051230101uka Kulic MD210
Active, not recruiting
Phase 1
Clinical Trial to evaluate the safety and efficacy of oral treatment with OST-122 in patients with moderate to severe ulcerative colitisModerate to severe ulcerative colitisTherapeutic area: Diseases [C] - Digestive System Diseases [C06]EUCTR2019-004090-50-ESONCOSTELLAE S.L.32
Active, not recruiting
Phase 1
A Phase I/IIa, Double-blind, Randomized, Placebo-controlled, Dose-Escalation Study of NI-0401 in Patients with Moderate to Severe Active Crohn´s DiseaseEUCTR2005-004313-15-GBovImmune S.A.60
Active, not recruiting
Phase 1
A Phase I/IIa, Double-blind, Randomized, Placebo-controlled, Dose-Escalation Study of NI-0401 in Patients with Moderate to Severe Active Crohn´s DiseaseModerate to Severe Active Crohn´s DiseaseEUCTR2005-004313-15-BEovImmune S.A.60
Completed
Phase 2
A Study Looking at the Safety and Effectiveness of a COVID-19 Vaccine Plus Adjuvant in South African AdultsCOVID-19PACTR202009726132275ovavax Inc4,704