Phase 2
N=28
Study to Evaluate the Efficacy and Safety of AMG 714 in Adult Patients With Type II Refractory Celiac Disease
Type II Refractory Celiac Disease (RCD-II) · In-situ Small Bowel T-cell Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT02633020 ↗Enrolled (actual)
28
Serious AEs
21.4%
Results posted
Dec 2019
Primary outcome: Primary: Percent Change From Baseline in the Percentage of Aberrant Intestinal Intraepithelial Lymphocytes With Respect to All Intraepithelial Lymphocytes — 2.45; 7.30 percent change — p=0.7451
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- AMG 714 (Biological); Placebo (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Amgen
- Primary completion
- Apr 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in the Percentage of Aberrant Intestinal Intraepithelial Lymphocytes With Respect to All Intraepithelial Lymphocytes |
2.45; 7.30 | 0.7451 |
| SECONDARY Percent Change From Baseline in the Percentage of Aberrant Intestinal Intraepithelial Lymphocytes With Respect to All Intestinal Epithelial Cells |
11.66; 49.88 | 0.1803 |
| SECONDARY Percent Change From Baseline in Villous Height to Crypt Depth (VH:CD) Ratio |
26.44; 15.77 | 0.6607 |
| SECONDARY Percentage of Participants With Improvement in Marsh Score at Week 12 |
35.3; 33.3 | 0.9204 |
| SECONDARY Percent Change From Baseline in Total Intraepithelial Lymphocyte Count at Week 12 |
26.84; 39.57 | 0.6885 |
| SECONDARY Number of Weekly Bowel Movements at Baseline and Week 12 |
10.3; 7.4; 11.3; 8.3 | 0.4469 |
| SECONDARY Percentage of Participants With Diarrhea at Baseline and Week 12 |
52.6; 22.2; 36.8; 44.4 | — |
| SECONDARY Change From Baseline in Total Weekly Gastrointestinal Symptom Rating Scale (GSRS) Score at Week 12 |
-0.14; 0.20 | 0.4832 |
| SECONDARY Change From Baseline in Total Celiac Disease GSRS (CeD-GSRS) Score at Week 12 |
-0.14; 0.17 | 0.5561 |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02633020). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.