Nine-Weeks Treatment With 683699 In Subjects With Moderately-To-Severely Active Crohn's Disease

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 2

Conditions

Crohn's Disease

Treatments

Drug: 683699

Study type

Interventional

Funder types

Industry

Identifiers

NCT00101946

683699/004

Details and patient eligibility

About

This study will evaluate the effectiveness and safety of the investigational drug 683699 in treating subjects with moderately to severely active CD (Crohn's Disease).

Enrollment

17 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Diagnosed with CD and reconfirmed in previous 2 years by a radiologic or endoscopic assessment including histology.
CDAI (Crohn's Disease Activity Index) score of 220-450 after 1 week of screening.
CRP (C-Reactive Protein) level of >4mg at screening.

Exclusion criteria

Significantly abnormal laboratory tests or ECG (electrocardiogram) results.
Current use of an elemental diet or parenteral nutrition.
Clinically significant positive stool culture.
Ongoing neoplastic disease of the bowel.
Bowel perforation other than fistulae.
Has an ileostomy or colostomy.
Fixed symptomatic gastrointestinal (GI) stricture within 6 months or obstructive symptoms within 3 months of screening.
Any bowel resection within 12 months of screening or bowel resection without subsequent demonstration of recurrence of active CD.
More than 100cm of bowel resected.
Non-curative bowel surgery with 2 months of screening.
Symptoms attributed to short bowel syndrome.
Uncontrolled bacterial, viral, or fungal infection or congenital or acquired immunodeficiency.
Women who are pregnant, breast feeding, or planning to become pregnant during the study.

Permitted medications:

Less than or equal to 20mg/day oral corticosteroids for at least 4 weeks prior to screening and on stable doses for 2 weeks prior to screening.
Azathioprine and 6-MP (6-Mercaptopurine) stable dose for 3 months prior to screening.
5-ASA (5-Aminosalicylic acid) stable dose for 1 month prior to screening.

Prohibited medications:

Greater than 20mg/day oral corticosteroids, or systemic intravenous corticosteroids, or antibiotics as a treatment for CD within 4 weeks prior to screening.
Cyclosporine or methotrexate during the 2 months prior to screening.
Infliximab or other biological treatments within 3 months prior to screening.