Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a multicenter, randomized, double-blind, placebo-controlled, sequential rising single-dose study in which approximately 56 subjects with SLE will be enrolled in 7 dosing cohorts
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AMG 557 | Experimental | AMG 557 administered as subcutaneous and intravenous doses. |
|
| Placebo | Placebo Comparator | No active drug |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMG 557 | Drug | AMG 557 is for the treatment of sybjects with systemic lupus erythematosus |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability | Subject incidence of treatment-emergent adverse events, vital signs, physical examinations, clinical laboratory safety tests, and ECGs | From 29 days to 169 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic profile of AMG 557 including Tmax, AUClast and Cmax | Serum concentration and derived PK parameters including Tmax, AUClast and Cmax | From 29 days to 169 days |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Anniston | Alabama | 36207 | United States | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27099766 | Derived | Sullivan BA, Tsuji W, Kivitz A, Peng J, Arnold GE, Boedigheimer MJ, Chiu K, Green CL, Kaliyaperumal A, Wang C, Ferbas J, Chung JB. Inducible T-cell co-stimulator ligand (ICOSL) blockade leads to selective inhibition of anti-KLH IgG responses in subjects with systemic lupus erythematosus. Lupus Sci Med. 2016 Apr 8;3(1):e000146. doi: 10.1136/lupus-2016-000146. eCollection 2016. | |
| 26138472 |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo |
| Drug |
contains no active drug |
|
| Phoenix |
| Arizona |
| 85013 |
| United States |
| Research Site | Los Angeles | California | 90033 | United States |
| Research Site | Los Angeles | California | 90048 | United States |
| Research Site | Michigan City | Indiana | 46360 | United States |
| Research Site | North Dartmouth | Massachusetts | 02747 | United States |
| Research Site | Manhasset | New York | 11030 | United States |
| Research Site | New York | New York | 10003 | United States |
| Research Site | Rochester | New York | 14642 | United States |
| Research Site | Duncansville | Pennsylvania | 16635 | United States |
| Research Site | Dallas | Texas | 75231 | United States |
| Research Site | Dallas | Texas | 75247 | United States |
| Research Site | London | NW10 7NS | United Kingdom |
| Derived |
| Welcher AA, Boedigheimer M, Kivitz AJ, Amoura Z, Buyon J, Rudinskaya A, Latinis K, Chiu K, Oliner KS, Damore MA, Arnold GE, Sohn W, Chirmule N, Goyal L, Banfield C, Chung JB. Blockade of interferon-gamma normalizes interferon-regulated gene expression and serum CXCL10 levels in patients with systemic lupus erythematosus. Arthritis Rheumatol. 2015 Oct;67(10):2713-22. doi: 10.1002/art.39248. |
| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000632508 | AMG 557 |
Not provided
Not provided
Not provided