NL-OMON49796已完成2 期
A multicentre randomized, double-blind, 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 - 204869
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 3
研究概览
简要总结
Trial is onging in other countries
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •AGE and WEIGHT:
- •1. 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:
- •2. Diagnosis of ulcerative colitis, established at least 3 months prior to
- •screening, as documented by diagnostic sigmoidoscopy or colonoscopy, and biopsy.
- •3. 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.
- •4. A history of at least one of the following:
- •* 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.
- •* Inadequate response to, loss of response to, intolerance to, or demonstrated
- •dependence on oral corticosteroids.
- •* Inadequate response to, loss of response to, or intolerance to at least one
- •approved advanced therapy for UC, including anti-TNF therapies, anti-integrin
- •therapies, anti-IL-12/23 monoclonal antibodies or JAK inhibitors.
- •5. Surveillance colonoscopy (performed according to local standards) within 12
- •months of screening (or during screening, if required) for participants with:
- •* Pancolitis of >8 years duration; or
- •* Patients with left-sided colitis of >12 years duration; or
- •* For patients for whom this criterion does not apply, colorectal cancer
- •surveillance should be undertaken according to local or national guidelines for
- •patients with age *50, or with other known risk factors for colorectal cancer.
- •6. Male and Female participants:
- •Both male and female participants are eligible to participate.
- •A female participant is eligible to participate if she is not pregnant, not
- •breastfeeding, and at least one of the following conditions applies:
- •* Not a woman of childbearing potential (WOCBP), see Section 10.4.1 of the
- •* A WOCBP who agrees to use a highly effective contraceptive method for at
- •least 4 weeks prior to dosing, until the Follow-Up visit. See Section 10.4.2
- •of the protocol.
- •INFORMED CONSENT:
- •7. Capable of giving signed informed consent as described in Section 10.1.3
- •10.1.3 of the protocol which includes compliance with the requirements and
- •restrictions listed in the informed consent form (ICF) and in the protocol.
排除标准
- •MEDICAL CONDITIONS:
- •1. Participants with a current diagnosis of indeterminate colitis, inflammatory
- •bowel disease-unclassified, Crohn*s disease, infectious colitis, or ischaemic
- •2. Participants with fulminant ulcerative colitis (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. Participants with 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 follows:
- •- Use of antimicrobials (antibacterials, antivirals, antifungals or
- •antiparasitic agents) for an infection within 30 days before first dose
- •(topical treatments may be allowed at the Medical Monitor*s discretion).
- •- A history of opportunistic infections within 1 year of screening (e.g.
- •Pneumocystis jirovecii, aspergillosis or CMV colitis). This does not include
- •infections that may occur in immunocompetent individuals, such as fungal nail
- •infections or vaginal candidiasis, unless it is of an unusual severity or
- •recurrent nature.
- •- Recurrent or chronic infection or other active infection that, in the opinion
- •of the Investigator, might cause this study to be detrimental to the patient.
- •- Symptomatic herpes zoster within 3 months prior to screening.
- •- History of tuberculosis (active or latent), irrespective of treatment status.
- •- A positive diagnostic TB test at screening (defined as a positive QuantiFERON
- •test). In cases where the QuantiFERON test is indeterminate, the participant
- •may have the test repeated once and if their second test is negative they will
- •be eligible. In the event a second test is also indeterminate, the investigator
- •has the option to undertake PPD testing. If the PPD reaction is <5 mm, then the
- •participant is eligible. If the reaction is *5 mm, or PPD testing is not
- •undertaken, the participant is not eligible.
- •- Positive Clostridium difficile toxin test during screening. However,
- •rescreening can be undertaken following successful treatment.
- •7. Current or history of chronic liver or biliary disease (with the exception
- •of Gilbert*s syndrome, asymptomatic gallstones or uncomplicated fatty liver
- •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 (e.g. heart, lung, kidney, liver, pancreas) or
- •haematopoietic stem cell/marrow transplant.
- •10. Any planned major surgical procedure during the study.
- •11. A history of malignant neoplasm within the last 5 years, except for
- •adequately treated non-metastatic basal or squamous cell cancers of the skin
- •(within 1 year) or carcin
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