Clinical trial NCT02637141: A Study to Evaluate the Efficacy and Safety of AMG 714 in Adult Patients With Celiac Disease
Official title: A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of AMG 714 in Adult Patients With Celiac Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Celiac Disease
Keywords: celiac
gluten
Interleukin 15 (IL-15)
AMG 714
gluten challenge
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2015-12-22
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to evaluate the efficacy and safety of AMG 714 for the attenuation of the effects of gluten exposure in adult patients with celiac disease during a gluten challenge.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of celiac disease by intestinal biopsy at least 12 months prior to screening
* On a gluten-free diet for at least 12 months
* Negative celiac serology
* Avoidance of pregnancy

Exclusion Criteria:

* Severe complications of celiac disease, such as refractory celiac disease
* Celiac symptoms
* Other concomitant autoimmune disease
* Chronic, active gastrointestinal disease
* Infections, concomitant diseases
* Prohibited medications

Primary outcomes:
measure: Percent Change From Baseline in Villous Height to Crypt Depth Ratio (VH:CD) at Week 12
timeFrame: Baseline and week 12
Secondary outcomes:
measure: Percent Change From Baseline in Intraepithelial Lymphocyte Density at Week 12
timeFrame: Baseline and week 12
measure: Number of Participants With Improvement in Marsh Score at Week 12
timeFrame: Baseline and week 12
measure: Percent Change From Baseline in Anti-Tissue Transglutaminase (tTG) Immunoglobulin A (IgA) Antibodies at Week 12
timeFrame: Baseline and week 12
measure: Change From Baseline in Anti-Deamidated Gliadin Peptide (DGP) Antibodies at Week 12
timeFrame: Baseline and week 12
measure: Number of Weekly Bowel Movements at Baseline and Week 12
timeFrame: Baseline and week 12
measure: Number of Participants With Diarrhoea at Baseline and Week 12
timeFrame: Baseline and week 12
measure: Percent Change From Baseline in Total Weekly Gastrointestinal Symptom Rating Scale (GSRS) Score at Week 12
timeFrame: Baseline and 12 weeks
measure: Change From Baseline in Total Celiac Disease GSRS (CeD-GSRS) Score at Week 12
timeFrame: Baseline and 12 weeks
Other outcomes:
Locations:
city: Oulu
country: Finland
facility: ODL
city: Tampere
country: Finland
facility: Tampere University Hospital
city: Turku
country: Finland
facility: CRST
Study officials:
affiliation: Amgen
name: Amgen, MD
role: STUDY_DIRECTOR
References:
citation: Lahdeaho ML, Scheinin M, Vuotikka P, Taavela J, Popp A, Laukkarinen J, Koffert J, Koivurova OP, Pesu M, Kivela L, Lovro Z, Keisala J, Isola J, Parnes JR, Leon F, Maki M. Safety and efficacy of AMG 714 in adults with coeliac disease exposed to gluten challenge: a phase 2a, randomised, double-blind, placebo-controlled study. Lancet Gastroenterol Hepatol. 2019 Dec;4(12):948-959. doi: 10.1016/S2468-1253(19)30264-X. Epub 2019 Sep 4.