Study to Evaluate the Efficacy and Safety of AMG 714 in Adult Patients With Type II Refractory Celiac Disease

Amgen

Status and phase: Completed; Phase 2

Conditions: In-situ Small Bowel T-cell Lymphoma; Type II Refractory Celiac Disease (RCD-II)

Treatments: Biological: Placebo; Biological: AMG 714

Study type: Interventional

Funder types: Industry

Identifiers

NCT02633020

CELIM-RCD-002

2015-004063-36 (EudraCT Number)

Details and patient eligibility

About

Protocol CELIM-RCD-002 is designed to evaluate the efficacy and safety of AMG 714 for the treatment of adult patients with type II refractory celiac disease (RCD-II), an in-situ small bowel T-cell lymphoma.

Enrollment: 28 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Confirmed diagnosis of refractory celiac disease Type II (RCD-II)
• Greater than 20% aberrant intraepithelial lymphocytes (IEL) as assessed by flow cytometry
• On a gluten-free diet for at least 6 months
• Avoid pregnancy

Exclusion criteria

• Enteropathy-Associated T cell Lymphoma (EATL)
• Infections
• Immune suppression
• Clinically significant co-morbidities

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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28 participants in 2 patient groups, including a placebo group

AMG 714

Experimental group

Description:

Participants were administered 8 mg/kg AMG 714 via intravenous infusion on day 0, day 7 and every 2 weeks thereafter through week 10.

Treatment:

Biological: AMG 714

Placebo

Placebo Comparator group

Description:

Participants were administered placebo via intravenous infusion on day 0, day 7 and every 2 weeks thereafter through week 10.

Treatment:

Biological: Placebo