Study of a Monoclonal Antibody KHK4083 in Moderate Ulcerative Colitis

Completed · Phase 2 · Has a placebo group

Conditions studied: Ulcerative Colitis, Digestive System Diseases, Colitis, Ulcerative, Colitis, Gastrointestinal Diseases, Inflammatory Bowel Diseases, Intestinal Diseases, Colonic Diseases, Autoimmune Disease, Abdominal Pain

In brief

The purpose of this study is to determine the safety and tolerability of administration of multiple ascending doses of KHK4083 and to select the highest dose tolerated by subjects with moderately active Ulcerative Colitis (UC) followed by a Long-term Extension Therapy (LTE) phase for eligible subjects with a clinical response.

Key facts

Study ID

NCT02647866

Run by

Kyowa Kirin, Inc.

People needed

66

Starts

2016-06-01

Expected to finish

2018-10-01

Last updated by the study team

2024-04-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject is able and willing to comply with study procedures, and to adhere to dosing, visit schedules and follow-up procedures as described in the protocol and ICF;
• Subject voluntarily signs/dates an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved ICF in accordance with regulatory and Institutional Guidelines;
• Male and female subjects ≥ 18 years of age at the time of enrollment;
• Subject has UC that was diagnosed at least 6 months prior to the Screening visit;
• Subject has moderately active UC with a total Mayo score of 4-9 and an endoscopic sub-score of at least 2, with disease that extends at least 15 cm from the anal verge;
• Subject has had previous treatment (within 5 years prior to Screening) with one or more of the following: corticosteroids, immunosuppressive medications or TNF antagonist therapy that was unsuccessful because of a lack of efficacy response.
• Female subjects (WOCBP) must have a negative pregnancy test at Screening and Baseline. WOCBP must agree to use effective contraception;
• Male subjects (including those who have had a vasectomy) must use adequate contraception during the study and for at least 6 months after the last dose of investigational product.

You may not qualify if…

• Subject, who, for any reason, is judged by the Investigator to be inappropriate for this study;
• Subject has a medical history of other clinically significant diseases/disorders;
• Two or more biologic treatments with different mechanisms of action (e.g., infliximab, vedolizumab and golimumab) or Three or more anti-TNF biologics e.g. infliximab, adalimumab
• Subject requires prescription treatment for UC, except for the stable, oral treatment of UC for 4 weeks prior to screening.
• Subject has received any of the following prior treatments or treatments within the specified time prior to the Baseline visit:
• Natalizumab, efalizumab, rituximab or other lymphocyte-depleting treatments, including but not limited, to alkylating agents (such as cyclophosphamide or chlorambucil) and total lymphoid irradiation at any time;
• TNF antagonists within 8 weeks, or 5 half-lives (up to 12 weeks);
• Vedolizumab within 16 weeks;
• Methotrexate, cyclosporine, mycophenolate, tacrolimus, thalidomide, or other immune altering drugs within 4 weeks (ophthalmologic preparations are permitted);
• 5-ASA enema, steroid enema or suppository use within 2 weeks ; and/or Investigational agents within 8 weeks or 5 half-lives (whichever is longer).
• Subject with recent, suspected or confirmed symptomatic stenosis of the colon, abdominal abscess, or ischemic colitis based on clinical or radiographic data; a history of toxic megacolon; or who had any previous surgery for UC;
• Subject with known colonic dysplasia, adenomas or polyposis;
• Subject had major surgery within 4 weeks prior to Screening or an anticipated requirement for major surgery;
• Subject with enteric pathogens (including Clostridium difficile);
• Subject with any of the following hematological and chemistry laboratory values:
• Platelet count < 100,000/mm3;
• Neutrophils < 1500/mm3;
• Serum creatinine ≥ 1.6 mg/dL (≥ 144.4 μmol/L);
• Alkaline phosphatase > 3 times the upper limit of normal (ULN);
• AST or ALT > 2 times ULN;
• Total bilirubin > 2 mg/dL, unless due to Gilbert's Syndrome;
• Serum albumin < 3 g/dL;
• Hemoglobin < 9 g/dL;
• Glycated serum hemoglobin A1c ≥ 9%.
• Subject has clinically significant cardiac disease;

Where it is running

• Study site — Greenville, South Carolina, United States
• Study site — Hradec Králové, Czechia
• Study site — Znojmo, Czechia
• Study site — Budapest, Hungary
• Study site — Budapest, Hungary
• Study site — Budapest, Hungary
• Study site — Bydgoszcz, Poland
• Study site — Rzeszów, Poland
• Study site — Sopot, Poland
• Study site — Tychy, Poland
• Study site — Warsaw, Poland
• Study site — Warsaw, Poland
• Study site — Warsaw, Poland
• Study site — Bucharest, Sector 2, Romania
• Study site — Krasnoyarsk, Russia
• Study site — Moscow, Russia
• Study site — Novosibirsk, Russia
• Study site — Penza, Russia
• Study site — Saint Petersburg, Russia
• Study site — Saint Petersburg, Russia
• Study site — Zemun, Belgrade, Serbia
• Bežanija Kosa — Belgrade, Serbia
• Study site — Kragujevac, Serbia

Full record on ClinicalTrials.gov

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