EUCTR2018-003278-28-FR
Active, not recruiting
Phase 1
A multicentre randomized, double-blind (sponsor open), placebo-controlled Phase 2 study to evaluate the safety, tolerability, efficacy, dose-response, pharmacokinetics and pharmacodynamics of repeat dosing of an anti-LAG3 cell depleting monoclonal antibody (GSK2831781) in patients with active ulcerative colitis
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- lcerative Colitis
- Sponsor
- GlaxoSmithKline Research & Development Limited
- Enrollment
- 320
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •AGE and WEIGHT: Participant must be 18 years of age or older and \>40kg at the time of signing the informed consent.
- •TYPE OF PARTICIPANT AND DISEASE CHARACTERISTICS:
- •Participants who have a:
- •\-Diagnosis of ulcerative colitis, established at least 3 months prior to screening, as documented by diagnostic sigmoidoscopy or colonoscopy, and biopsy.
- •\-Complete Mayo Score of 6 to 12, with disease extending \=15cm from the anal verge, with a centrally read endoscopic subscore of \=2 at screening endoscopy, and a rectal bleeding subscore \=1\.
- •\-A history of at least one of the following:
- •(1\) Inadequate response to, loss of response to, or intolerance to azathioprine or mercaptopurine (including thiopurine methyltransferase (TPMT) genetic mutation precluding use), ciclosporin, tacrolimus or methotrexate.
- •(2\) Inadequate response to, intolerance to, or demonstrated dependence on oral corticosteroids.
- •(3\) Inadequate response to, loss of response to, or intolerance to one biologic class ONLY for the treatment of UC: either one or more anti\-TNF therapies (e.g. infliximab, adalimumab, golimumab, or biosimilar) OR vedolizumab.
- •\- Surveillance colonoscopy (performed according to local standards) within 12 months of screening (or during screening, if required) for participants with:
Exclusion Criteria
- •Medical Conditions:
- •(1\) Current diagnosis of indeterminate colitis, inflammatory bowel disease\-unclassified, Crohn's Disease, infectious colitis, or ischaemic colitis
- •(2\) Fulminant UC (as defined by 6 bloody stools daily AND 1 or more of: i) body temperature \=100\.4°F (or 38°C) or ii) heart rate \>90 beats per minute), or toxic megacolon
- •(3\) Prior extensive colonic resection, subtotal or total colectomy, or proctocolectomy, or planned surgery for UC
- •(4\) Any uncontrolled medical conditions, other than active UC, that in the opinion of the investigator put the participant at unacceptable risk or interfere with study assessments or integrity of the data. Other medical conditions should be stable at the time of screening and be expected to remain stable for the duration of the study
- •(5\) Unstable lifestyle factors, such as alcohol use to excess or recreational drug use, to the extent that in the opinion of the investigator they would interfere with the ability of a participant to complete the study
- •(6\) An active infection or a history of serious infections as described fully in the protocol.
- •(7\) Current or history of chronic liver or biliary disease (with the exception of Gilbert’s syndrome, asymptomatic gallstones or uncomplicated fatty liver disease)
- •(8\) Hereditary or acquired immunodeficiency disorder, including immunoglobulin deficiency (unless the participant has a documented history of selective IgA deficiency)
- •(9\) A major organ transplant or haematopoietic stem cell/marrow transplant
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Phase 1
Safety, tolerability, efficacy and dose-response of GSK2831781 in ulcerative colitis.lcerative ColitisMedDRA version: 20.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000004856Therapeutic area: Diseases [C] - Digestive System Diseases [C06]EUCTR2018-003278-28-HUGlaxoSmithKline Research & Development Limited320
Active, not recruiting
Phase 1
A multicentre, randomised, double-blind (sponsor-unblinded), placebo-controlled study with open label extension to investigate the safety and tolerability, pharmacokinetics, pharmacodynamics, and efficacy of GSK2982772 in subjects with active ulcerative colitisEUCTR2016-001833-29-NLGlaxoSmithKline Research & Development Ltd36
Active, not recruiting
Phase 1
A multicentre, randomised, double-blind (sponsor-unblinded), placebo-controlled study to investigate the safety and tolerability, pharmacokinetics, pharmacodynamics, and efficacy of GSK2982772 in subjects with moderate to severe rheumatoid arthritis.EUCTR2016-000912-13-GBGlaxoSmithKline Research & Development Ltd52
Active, not recruiting
Phase 1
A multicentre, randomised, double-blind (sponsor-unblinded), placebo-controlled study with open label extension to investigate the safety and tolerability, pharmacokinetics, pharmacodynamics, and efficacy of GSK2982772 in subjects with active ulcerative colitisActive ulcerative colitisMedDRA version: 20.0Level: HLGTClassification code 10017969Term: Gastrointestinal inflammatory conditionsSystem Organ Class: 10017947 - Gastrointestinal disordersTherapeutic area: Diseases [C] - Immune System Diseases [C20]EUCTR2016-001833-29-SEGlaxoSmithKline Research & Development Ltd36
Completed
Phase 2
A multicentre, randomised, double-blind (sponsor-unblinded), placebo-controlled study with open label extension to investigate the safety and tolerability, pharmacokinetics, pharmacodynamics, and efficacy of GSK2982772 in subjects with active ulcerative colitis (study 202152)ulcerative colitis10017969NL-OMON45582GlaxoSmithKline3