A Phase 2a Study to Evaluate the Safety, Tolerability, Pharmacodynamics and Efficacy of AG011 in Ulcerative Colitis

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

July 31, 2008

Primary Completion Date

September 30, 2009

Study Completion Date

September 30, 2009

Conditions
Moderately Active Ulcerative Colitis
Interventions
BIOLOGICAL

AG011

Capsules (low, mid or high dose), twice daily for 28 days, combined with Enema (low, mid or high dose respectively), once daily for 28 days.

OTHER

Placebo

Capsules (matching placebo for low, mid or high dose), twice daily for 28 days, combined with Enema (matching placebo for low, mid or high dose respectively), once daily for 28 days.

Trial Locations (18)

B-2820

Imelda Bonheiden, Bonheiden

Unknown

UCL St. Luc, Brussels

AZ Groeninge Campus St.-Niklaas, Kortrijk

The office of Dr. Donald Daly, Victoria

Hotel Dieu Hospital, Kingston

Ottawa Hospital General Campus, Ottawa

Mount Sinai Hospital, Toronto

B-2650

UZ Antwerpen, Edegem

B-9000

UZ Gent, Ghent

B-3000

UZ Leuven, Leuven

V6Z 2K5

GI Research Institute, Vancouver

N6A 4G5

LHSC - South Street Campus, London

N6A 5A5

LHSC - University Campus, London

G1S 4L8

Hôpital St-Sacrement, Québec

2333 ZA

Leiden University Medical Center, Leiden

SE-221 85

Lund University Hospital, Lund

SE-701 85

Orebro University Hospital, Örebro

SE- 114 86

Sophiahemmet, Stockholm

Sponsors

Lead Sponsor

All Listed Sponsors
lead

ActoGeniX N.V.

INDUSTRY

NCT00729872 - A Phase 2a Study to Evaluate the Safety, Tolerability, Pharmacodynamics and Efficacy of AG011 in Ulcerative Colitis | Biotech Hunter | Biotech Hunter