Efficacy&Safety of ALTB-168 in Patients With Moderate to Severe Active,Anti-TNF Alpha and/or Anti-integrin Refractory UC

Stopped early · Phase 2

Conditions studied: Ulcerative Colitis

In brief

To evaluate the efficacy and safety of Neihulizumab (ALTB-168) 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.

Key facts

Study ID: NCT03298022
Run by: AltruBio Inc.
People needed: 24
Starts: 2018-05-04
Expected to finish: 2020-06-01
Last updated by the study team: 2024-01-05

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patients must provide written informed consent;
Age 18-75 years;
Diagnosis of UC ≥ 12 weeks prior to screening by full colonoscopy (i.e., ≥ 12 weeks after first diagnosis by a physician according to American College of Gastroenterology guidelines);
Moderate-to-severe active UC, at time of screening, defined as:
Mayo Clinic Score (MCS) of 6 points or higher, AND
a centrally read MCS endoscopic subscore of grade 2 or higher, AND
MCS rectal bleeding subscore of 1 point or higher, AND
disease extending 15 cm or more from the anal verge;
Stable doses of concomitant medications, including :
Stable oral corticosteroids (i.e., ≤ 20 mg/day of prednisone, ≤ 9 mg/day of budesonide) ≥ 2 weeks before D1 dosing; Taper of oral corticosteroids per Investigator's discretion during the study is allowed;
Stable oral 5-amyinosalicylic acid dose ≥ 2 weeks before D1 dosing;
Stable immunosuppressant including azathioprine, mercaptopurine, or methotrexate ≥ 8 weeks before D1 dosing. Patients taking methotrexate also are advised to take folic acid 1 mg/day or equivalent if there is no contraindication;
Stable doses of probiotics ≥ 2 weeks before D1 dosing;
Stable anti-diarrheas ≥ 2 weeks before D1 dosing;
Patients must have previously received anti-tumor necrosis factor alpha (anti- TNF alpha and/or anti-integrin therapy for UC and demonstrated an inadequate response, loss of response, or intolerance, and must have discontinued therapy ≥ 8 weeks before D1 dosing;
Patients previously treated with cyclosporine or tacrolimus must have discontinued therapy ≥ 4 weeks before D1 dosing;
Topical corticosteroids and topical 5-amyinosalicylic acid preparations must have been withdrawn ≥ 2 weeks before D1 dosing;
Nonsteroidal anti-inflammatory drugs (NSAIDs) must have been discontinued ≥ 4 weeks before D1 dosing;
Tofacitinib or other Janus kinase (JAK) inhibitors must have been discontinued ≥ 2 weeks before D1 dosing;
Patients previously treated with tube feeding, defined formula diets, or parenteral alimentation/nutrition must have discontinued treatment 3 weeks before D1 dosing;
Females with reproductive potential must have a negative pregnancy test result before enrollment. Men and women with reproductive potential have to be willing to use a highly effective method of contraception from study start to ≥ 3 months after the final dose of the study drug. A highly effective method of birth control is defined as one which results in a low failure rate (less than 1% per year).

You may not qualify if…

GI related exclusion criteria:
Indeterminate colitis (Inflammatory bowel disease unclassified, IBD-U) or suspected Crohn's disease
Any history of colectomy
Presence of an ileostomy or colostomy
A history or evidence of colonic mucosal dysplasia
Short gut syndrome
General health related exclusion criteria:
Pregnant or lactating
Inability to comply with study protocol in the opinion of the investigator
History of dysplasia or malignancy in recent 5 years, except completely excised basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
Cirrhosis or active alcohol abuse per the judgement of investigator
Poorly controlled diabetes (HbA1c > 8.0%)
Significant screening ECG abnormalities, including evidence of acute myocardial infarction, complete left bundle branch block, second-degree heart block, or complete heart block
Impaired renal function (calculated creatinine clearance < 60 mL/min)
Impaired hepatic function in the absence of diagnosis of primary sclerosing cholangitis, serum transaminase > 2.5x Upper Limit Normal (ULN), alkaline phosphatase > 2.5x ULN, or increased total bilirubin judged by the investigator to be clinically significant, or a diagnosis of primary sclerosing cholangitis, serum transaminases > 3x ULN, alkaline phosphatase > 3x ULN, or total bilirubin > 2.5x ULN judged by the investigator to be clinically significant
Moderate to severe anemia (Hb < 8g/dL)
Thrombocytopenia (platelet count < 75,000/uL)
Evidence of current or previous clinically significant disease, medical condition or finding in the medical examination that in the opinion of the investigator, would compromise the safety of the patient or quality of the data
Requiring parenteral corticosteroid treatment.
Received any investigational product within 1 year.
History of drug abuse according to the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-V) criteria within 12 months prior to screening or positive drug screening tests.
Infection related exclusion criteria:
Human immune deficiency virus (HIV) infection or known HIV-related malignancy.
Acute or chronic hepatitis B or C, or carrier status. Patients with anti-HBc Ab but with undetectable anti-HBs Ab should also be excluded.
Positive IgM antibody titers in the presence of negative IgG titers to Epstein-Barr virus

Where it is running

Lynn Institute of the Ozarks — Little Rock, Arkansas, United States
Stomach Doctor - Surinder Saini, MD - Fountain Valley — Newport Beach, California, United States
Wellness Clinical Research (WCR) — Hialeah, Florida, United States
Wellness Clinical Research (WCR) — Lake Wales, Florida, United States
Northwestern University Feinberg School of Medicine — Chicago, Illinois, United States
University of Chicago — Chicago, Illinois, United States
Capitol Research — Rockville, Maryland, United States
Weill Cornell Medical College — New York, New York, United States
University of Rochester Medical Center — Rochester, New York, United States
Baylor College of Medicine — Houston, Texas, United States
University of Washington Medical Center (UWMC) - Digestive Disease Center — Seattle, Washington, United States
Wellness Clinical Research (WCR) — Vega Baja, Puerto Rico

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.