Basiliximab in Moderate to Severe Ulcerative Colitis

Sponsor

Cerimon Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00430898

Collaborator

(none)

181

Enrollment

Locations

Arms

Duration (Months)

2.7

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the safety, effectiveness and pharmacokinetics of two levels of intravenous basiliximab in ulcerative colitis, compared to placebo.

Condition or Disease	Intervention/Treatment	Phase
Ulcerative Colitis	Drug: Basiliximab	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

181 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety, Efficacy, and Pharmacokinetics of Multiple Doses of Basiliximab, With Concomitant Corticosteroids, in Steroid-Refractory Ulcerative Colitis

Study Start Date :

Jan 1, 2007

Actual Primary Completion Date :

Sep 1, 2008

Actual Study Completion Date :

Sep 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: 1. Placebo Placebo to mimic 40 mg of Simulect	Drug: Basiliximab 3 doses of 40mg, IV at baseline, week 2, and week 4 Other Names: Simulect
Experimental: 2. 40 mg Simulect 40 mg of Simulect	Drug: Basiliximab 3 doses of 40mg, IV at baseline, week 2, and week 4 Other Names: Simulect

Arm

Intervention/Treatment

Placebo Comparator: 1. Placebo

Placebo to mimic 40 mg of Simulect

Drug: Basiliximab

3 doses of 40mg, IV at baseline, week 2, and week 4

Other Names:

Simulect

Experimental: 2. 40 mg Simulect

40 mg of Simulect

Drug: Basiliximab

3 doses of 40mg, IV at baseline, week 2, and week 4

Other Names:

Simulect

Outcome Measures

Primary Outcome Measures

Change in Mayo Score, Safety [At week 8]

Secondary Outcome Measures

Clinical remission at week 4; clinical response at weeks 4 and 8; use of rescue medication; hospitalization or colectomy; and concomitant steroid use [at week 4 and 8]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

In addition to others,

Men or women age 18-75
Diagnosis of ulcerative colitis confirmed through screening endoscopy.
Extent of disease must involve at least the left colon
Moderate to severe disease (Mayo Score 6-12). Systemic features of tachycardia, fever, and/or significant anemia should not be present.
Inadequate response despite treatment with prednisone 40 - 50 mg/day (or other oral steroid at equivalent dose) orally for a minimum of 14 days immediately preceding study entry

Exclusion Criteria:

In addition to other protocol-defined conditions,

Pregnancy
Stool study that shows presence of ova and parasites, significant bacterial pathogens, or C. difficile toxin
Colitis that is indeterminate, suggestive of Crohn's disease, or isolated to the rectum, based on endoscopic and/or biopsy findings
Severely ill patients as evidenced by protocol-defined systemic criteria
Chest radiograph abnormalities consistent with an infectious process
History of colonic dysplasia
HIV infection
Known viral Hepatitis B or C infection
History of or exposure to tuberculosis within 6 months before study entry

Contacts and Locations

Locations

	City	State	Country	Postal Code
1	Anaheim	California	United States
2	Roseville	California	United States	95661
3	Golden	Colorado	United States
4	Littleton	Colorado	United States
5	Hollywood	Florida	United States
6	Jacksonville	Florida	United States
7	Winter Park	Florida	United States	32789
8	Atlanta	Georgia	United States
9	Chicago	Illinois	United States	60637
10	Urbana	Illinois	United States	61801
11	Indianapolis	Indiana	United States	46202
12	Topeka	Kansas	United States	66606
13	Lexington	Kentucky	United States	40536
14	Boston	Massachusetts	United States	02114
15	Troy	Michigan	United States
16	Egg Harbor Twp	New Jersey	United States	08234
17	Great Neck	New York	United States
18	New York	New York	United States
19	Fargo	North Dakota	United States	58104
20	Cleveland	Ohio	United States	44195
21	Sewickley	Pennsylvania	United States	15143
22	Germantown	Tennessee	United States
23	Fort Worth	Texas	United States	76104
24	Galveston	Texas	United States
25	Houston	Texas	United States	77090
26	Leuven		Belgium	3000
27	Mlada Boleslav		Czech Republic	293 50
28	Praha 10		Czech Republic	100 34
29	Praha 4		Czech Republic
30	Praha 7		Czech Republic	170 00
31	Tabor		Czech Republic	390 03
32	Usti nad Orlici		Czech Republic	562 18
33	Bangalore		India	560 054
34	Cochin		India	682017
35	Hyderabaad		India	500012
36	Kolkata		India	700020
37	Lucknow		India	226014
38	Ludhiana		India	141001
39	Mumbai		India	400016
40	New Delhi		India	110076
41	Visakhapatnam		India	530 002
42	Gdansk		Poland
43	Krakow		Poland	31-826
44	Krakow		Poland
45	Poznan		Poland	60-353
46	Sopot		Poland	81-756
47	Sopot		Poland	81-820
48	Warszawa		Poland	02-098
49	Wroclaw		Poland	54-144
50	Moscow		Russian Federation	115446
51	Moscow		Russian Federation	121309
52	Samara		Russian Federation	443011
53	Smolensk		Russian Federation	214001
54	Bratislava		Slovakia	811 07
55	Bratislava		Slovakia	851 01
56	Nitra		Slovakia	949 01
57	Nove Mesto nad Vahom		Slovakia	915 01
58	Presov		Slovakia	080 01
59	Dnepropetrovsk		Ukraine	49074
60	Ivano-Frankivsk		Ukraine	76000
61	Kharkiv		Ukraine	61037
62	Kyiv		Ukraine	01021
63	Kyiv		Ukraine	04210
64	Bristol		United Kingdom	BS2 8HW
65	Derbyshire		United Kingdom	DE22 3NE
66	London		United Kingdom	WC1E 6DB
67	Stoke on Trent		United Kingdom	ST4 6QB
68	Wigan		United Kingdom	WN1 2NN