Study of Vedolizumab in Patients With Moderate to Severe Crohn's Disease (GEMINI III)

Millennium Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Crohn's Disease

Treatments: Other: Placebo; Drug: vedolizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01224171

2009-016488-12 (EudraCT Number)

U1111-1158-2581 (Registry Identifier)

C13011

NL34356.078.10 (Registry Identifier)

Details and patient eligibility

About

This study in patients with moderately to severely active Crohn's disease is designed to establish the efficacy and safety of vedolizumab for the induction of clinical response and remission.

Full description

After completing the study, patients were eligible to enroll in a long term safety study with continued access to vedolizumab (study C13008; NCT00790933) if study drug was well tolerated, and no major surgical intervention for Crohn's disease occurred or was required.

Participants who did not enroll in Study C13008 were to complete the Final Safety visit (16 weeks after the last dose of study drug) for a maximum time on study of 22 weeks.

Enrollment: 416 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Age 18 to 80
• Diagnosis of moderately to severely active Crohn's disease
• Crohn's Disease involvement of the ileum and/or colon
• Demonstrated, over the previous 5 year period, an inadequate response to, loss of response to, or intolerance of at least one conventional therapy as defined by the protocol
• May be receiving a therapeutic dose of conventional therapies for inflammatory bowel disease (IBD) as defined by the protocol

Exclusion Criteria

• Evidence of abdominal abscess at the initial screening visit
• Extensive colonic resection, subtotal or total colectomy
• History of >3 small bowel resections or diagnosis of short bowel syndrome
• Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine
• Have received non permitted therapies within either 30 or 60 days, depending on the medication, as stated in the protocol
• Chronic hepatitis B or C infection; human immunodeficiency virus (HIV) infection
• Active or latent tuberculosis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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416 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Participants received placebo intravenous infusion at Weeks 0, 2 and 6.

Treatment:

Other: Placebo

Vedolizumab

Experimental group

Description:

Participants received 300 mg intravenous vedolizumab at Weeks 0, 2, and 6.

Treatment:

Drug: vedolizumab