Clinical trial NCT00656890: A Study of MDX-1100 in Subjects With Active Ulcerative Colitis
Official title: A Phase 2, Multi-dose, Double-blind, Placebo-controlled, Randomized, Multicenter Study of MDX-1100 (Anti-CXCL10 Human Monoclonal Antibody) in Subjects With Active Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ulcerative Colitis
Keywords: ulcerative colitis, rectal bleeding
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2008-04-11
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the safety and tolerability of the MDX-1100 regimen in subjects with active Ulcerative colitis(UC) and determine the response rate at day 57 in patients administered MDX-1100.


Eligibility criteria: Inclusion Criteria:

* Subjects with active UC on either 5-ASA,corticosteroids,azathioprine(AZA) and or/6-mercaptopurine(6-MP);
* Mayo score of 6 to 10 points with moderate to severe disease on endoscopy
* Subjects on the following medications;

  1. prednisolone ≤ 20 mg daily (or equivalent) (dose must be stable for at least 2 weeks prior to study drug administration)
  2. 5-ASA (dose must be stable for at least 4 weeks prior to study drug administration)
  3. AZA or 6-MP (dose must be stable for at least 3 months prior to study drug administration)
  4. Rectal steroids or 5-ASA (must have been stable for at least 4 weeks prior to study drug)

Exclusion Criteria:

* Anti-TNF therapy within 8 weeks before study drug administration
* Contraindication to colonoscopy or sigmoidoscopy
* Primary or secondary immunodeficiency
* Autoimmune disease besides UC, with the exceptions of Sjogren's syndrome or hypothyroidism
* History of malignancy, excluding adequately treated and cured basal or squamous cell of the skin, or cervical carcinoma in situ
* Evidence of acute or chronic infection
* Clinically significant disease requiring medication

Primary outcomes:
measure: Change in Mayo score at Day 57 compared with Screening
timeFrame: Day 57
Secondary outcomes:
measure: the remission rate
timeFrame: Day 57
Other outcomes:
Locations:
city: Port Orange
country: United States
facility: Advanced Medical Research Center
state: Florida
city: Tampa
country: United States
facility: Florida Medical Clinic-Tampa Clinic
state: Florida
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine
state: Illinois
city: Chevy Chase
country: United States
facility: Chevy Chase Clinical Research
state: Maryland
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
city: Dayton
country: United States
facility: Dayton Science Institute
state: Ohio
city: Abbotsford
country: Canada
state: British Columbia
city: Vancouver
country: Canada
state: British Columbia
city: Toronto
country: Canada
state: Ontario
city: Olomouc
country: Czech Republic
city: Prague
country: Czech Republic
city: Strakonice
country: Czech Republic
city: Tabor
country: Czech Republic
city: Usti nad Labem
country: Czech Republic
city: Valasske Mezifici
country: Czech Republic
city: Budapest
country: Hungary
city: Debrecen
country: Hungary
city: Gyula
country: Hungary
city: Kaposvar
country: Hungary
city: Kecskemet
country: Hungary
city: Nagykanizsa
country: Hungary
city: Siofok
country: Hungary
city: Vac
country: Hungary
city: Zalaegerszeg
country: Hungary
city: Daugavpils
country: Latvia
city: Riga
country: Latvia
city: Valmiera
country: Latvia
city: Bucharest
country: Romania
city: Cluj
country: Romania
city: Oradea
country: Romania
city: Tg. Mures
country: Romania
city: Timisoara
country: Romania
city: Moscow
country: Russian Federation
city: Saratov
country: Russian Federation
city: Yaroslavl
country: Russian Federation
city: Chernivtsy
country: Ukraine
city: Dniepropetrovsk
country: Ukraine
city: Donetsk
country: Ukraine
city: Kharkiv
country: Ukraine
city: Kharkov
country: Ukraine
city: Kiev
country: Ukraine
city: Kyiv
country: Ukraine
city: Lviv
country: Ukraine
city: Simferopol
country: Ukraine
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: Mayer L, Sandborn WJ, Stepanov Y, Geboes K, Hardi R, Yellin M, Tao X, Xu LA, Salter-Cid L, Gujrathi S, Aranda R, Luo AY. Anti-IP-10 antibody (BMS-936557) for ulcerative colitis: a phase II randomised study. Gut. 2014 Mar;63(3):442-50. doi: 10.1136/gutjnl-2012-303424. Epub 2013 Mar 5.