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AMG 714 · 4 trials · 5 indications
The primary endpoint in this study was the change form baseline in the percentage of aberrant intestinal intraepithelial lymphocytes (IELs) with respect to total IELs, as assessed by flow cytometry (Immunological Response 1). Intraepithelial lymphocytes (IELS) are white blood cells interspersed between epithelial cells of the small and large intestine where they function to preserve the integrity of the mucosal barrier by protecting the epithelium against pathogen or immune-induced pathology. In refractory coeliac disease type 2, aberrant intraepithelial lymphocytes make up 20% or more of total intraepithelial lymphocytes. Aberrant IELs were defined by flow cytometry as surface cluster of differentiation (CD)3-negative, intracellular CD3-positive IELs (sCD3-, icCD3+).
Attenuation of the effects of gluten exposure was assessed by measuring the percent change from baseline in villous height to crypt depth ratio after 10 weeks of gluten challenge. Villi are the small fingerlike projections that line the small intestine and promote nutrient absorption and are often shortened in patients with celiac disease. Crypts are grooves between the villi that are often elongated in patients with celiac disease. A decreased VH:CD ratio indicates worsening disease. Small bowel biopsies were performed at baseline and week 12; histological assessments were performed by a blinded central pathologist.
| Arm | Type | Description |
|---|---|---|
| AMG 714 | EXPERIMENTAL | Participants were administered 8 mg/kg AMG 714 via intravenous infusion on day 0, day 7 and every 2 weeks thereafter through week 10. |
| Placebo | PLACEBO_COMPARATOR | Participants were administered placebo via intravenous infusion on day 0, day 7 and every 2 weeks thereafter through week 10. |
| AMG 714 150 mg | EXPERIMENTAL | Participants received 150 mg AMG 714 via subcutaneous injection once every 2 weeks for a total of 6 doses over 10 weeks from day 0. Participants received gluten-free cookies twice a day for the first 2 weeks and gluten-containing cookies twice a day from weeks 2 to 12 (gluten-challenge). |
| AMG 714 300 mg | EXPERIMENTAL | Participants received 300 mg AMG 714 via subcutaneous injection once every 2 weeks for a total of 6 doses over 10 weeks from day 0. Participants received gluten-free cookies twice a day for the first 2 weeks and gluten-containing cookies twice a day from weeks 2 to 12 (gluten-challenge). |
| Name | Type | Description |
|---|---|---|
| AMG 714 | BIOLOGICAL | Administered via a 120-minute IV infusion for a total of 7 times over 10 weeks. |
| Placebo | BIOLOGICAL | Administered via a 120-minute IV infusion for a total of 7 times over 10 weeks. |
| Placebo Gluten Challenge | OTHER | Gluten-free cookies (Finnish rusks) |
| Gluten Challenge | OTHER | Gluten-containing cookies (Finnish rusks), 1-2 g gluten per serving |
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 L...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Sanofi SA Sponsored ADR | SNY | 1 | PHASE2 | Amlitelimab |
| Forte Biosciences Inc. | FBRX | 1 | PHASE2 | FB102 |
| Teva Pharmaceutical Industries Limited Sponsored ADR | TEVA | 1 | PHASE2 | TEV-53408 |
| Barinthus Biotherapeutics plc Sponsored ADR | BRNS | 1 | EARLY_PHASE1 | VTP-1000 |
| TScan Therapeutics, Inc. | TCRX | 1 | - | Undisclosed |
AMG 714 is a monoclonal antibody being studied for use in psoriasis, rheumatoid arthritis, celiac disease, and Type II refractory celiac disease (RCD-II). It is an investigational drug in Phase 2 clinical development and is not approved for any indication.
AMG 714 is being developed by Amgen Inc., a biopharmaceutical company traded on NASDAQ under the ticker AMGN. The drug is currently in Phase 2 clinical trials for multiple indications.
AMG 714 is in Phase 2 clinical development. It has completed Phase 2 trials in rheumatoid arthritis, psoriasis, celiac disease, and Type II refractory celiac disease. The drug remains investigational and has not received FDA approval.
AMG 714 has completed four Phase 2 trials. NCT00433875 studied the drug in 180 patients with rheumatoid arthritis. NCT00443326 enrolled 22 patients with moderate to severe psoriasis. NCT02633020 evaluated 28 patients with Type II refractory celiac disease, and NCT02637141 studied 64 patients with celiac disease.
Yes, AMG 714 has been studied in celiac disease and Type II refractory celiac disease (RCD-II). A Phase 2 trial in celiac disease enrolled 64 patients in Finland, and a separate Phase 2 trial in RCD-II enrolled 28 patients across the United States, Finland, France, Netherlands, and Spain.