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To evaluate the efficacy and safety of Neihulizumab (AbGn-168H) administered intravenously in patients with moderate to severe active ulcerative colitis who are refractory or intolerant to anti-Tumor Necrosis Factor α and/or anti-integrin treatments.
This is a Phase II, open label, single arm, multiple dose proof of principle study to test the efficacy and safety of Neihulizumab in patients with moderate to severe active ulcerative colitis and who has failed or are intolerant to anti-TNFα and/or anti-integrin therapy. A minimum of 35 patients and a maximum of 40 will be recruited in 1 dosing group. For efficacy evaluation, the primary endpoint is the proportion of patients with clinical response, defined as defined as a ≥ 3-point reduction in complete Mayo score, a 30% or greater decrease from the baseline score, and with a 1-point or greater decrease of the rectal bleeding subscale or an absolute rectal bleeding score of 0 or 1 at Week 12. Safety assessments will consist of evaluating physical examination, vital signs (blood pressure, heart rate, respiratory rate, body temperature and oxygen saturation), safety laboratory tests, adverse events and tolerability.
Not yet recruiting
AbGenomics International, Inc.
Published on BioPortfolio: 2017-10-03T05:44:51-0400
To evaluate efficacy, safety, tolerability, and immunogenicity of AbGn-168H administered intravenously in patients with active psoriatic arthritis.
To establish the pharmacokinetic, pharmacodynamic, safety and efficacy profiles of Neihulizumab in patients with steroid-refractory acute graft-versus-host disease(sr-aGvHD)
Efficacy of ulcerative colitis to induce remission in patients with moderate to severe active ulcerative colitis.
Graves disease in ulcerative colitis: The connection between Graves disease and Inflammatory bowel disease is well known in the literature, but thyroid disorders have not been considered ...
Colitis from reactivation of established CMV colonization can complicate the clinical course in patients with an acute flare of ulcerative colitis (UC). Accurate and timely detection of ac...
Tacrolimus is effective for refractory ulcerative colitis in adults, while data for children is sparse. We aimed to evaluate the effectiveness and safety of tacrolimus for induction and maintenance th...
There is substantial compelling clinical evidence implicating certain dietary components in the development and clinical course of progression in ulcerative colitis (UC). The current study aimed to as...
Systemic molecular mediators of inflammation differentiate between Crohn's disease and ulcerative colitis, implicating threshold levels of IL-10 and relative ratios of pro-inflammatory cytokines in therapy.
Faecal diversion is associated with improvements in Crohn's disease but not ulcerative colitis, indicating differing mechanisms mediate the diseases. This study aimed to investigate levels of systemic...
There are limited data on the most cost-effective sequencing of biologics for ulcerative colitis (UC).
Appendicectomy may reduce relapses and need for medication in patients with ulcerative colitis, but long-term prospective data are lacking. This study aimed to analyse the effect of appendicectomy in ...
Chronic, non-specific inflammation of the GASTROINTESTINAL TRACT. Etiology may be genetic or environmental. This term includes CROHN DISEASE and ULCERATIVE COLITIS.
Inflammation of the COLON that is predominantly confined to the MUCOSA. Its major symptoms include DIARRHEA, rectal BLEEDING, the passage of MUCUS, and ABDOMINAL PAIN.
An acute form of MEGACOLON, severe pathological dilatation of the COLON. It is associated with clinical conditions such as ULCERATIVE COLITIS; CROHN DISEASE; AMEBIC DYSENTERY; or CLOSTRIDIUM ENTEROCOLITIS.
A humanized monoclonal antibody that binds specifically to TNF-ALPHA and blocks its interaction with endogenous TNF RECEPTORS to modulate INFLAMMATION. It is used in the treatment of RHEUMATOID ARTHRITIS; PSORIATIC ARTHRITIS; CROHN'S DISEASE and ULCERATIVE COLITIS.
A surgical procedure involving the excision of the COLON and RECTUM and the formation of an ILEOANAL RESERVOIR (pouch). In patients with intestinal diseases, such as ulcerative colitis, this procedure avoids the need for an OSTOMY by allowing for transanal defecation.
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...