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Also known as PRV-015
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 |
AMG 714 is an investigational monoclonal antibody being studied for psoriasis, celiac disease, rheumatoid arthritis, and Type II refractory celiac disease (RCD-II). It is in Phase 2 clinical development and is not approved by the FDA.
AMG 714 is a monoclonal antibody, but its specific molecular target has not been disclosed in available information. It is being evaluated for autoimmune and inflammatory conditions including psoriasis, celiac disease, and rheumatoid arthritis.
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 is an investigational drug and has not received FDA approval. Clinical trials have been completed for rheumatoid arthritis, psoriasis, celiac disease, and Type II refractory celiac disease.
AMG 714 has completed Phase 2 trials including NCT00433875 for rheumatoid arthritis, NCT00443326 for psoriasis, NCT02633020 for Type II refractory celiac disease, and NCT02637141 for celiac disease. All trials are completed with no active studies listed.
AMG 714 is the primary name for this investigational monoclonal antibody. No alternative names have been reported in available clinical trial information. It is being studied under this identifier across all registered trials.