Trial · NCT01389895
Safety Study of AMG 557 in Subjects With Subacute Cutaneous Lupus Erythematosus
NCT01389895, Phase 1, Terminated, Amgen
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety Study of AMG 557 in Subjects With Subacute Cutaneous Lupus Erythematosus. Trials, record NCT01389895. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01389895
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety Study of AMG 557 in Subjects With Subacute Cutaneous Lupus Erythematosus
- NCT number
- NCT01389895
- Status
- Terminated
- Phases
- Phase 1
- Enrollment
- 1 participants, actual
- Lead sponsor
- Amgen
- Conditions
- Cutaneous Lupus, Lupus
- Interventions
- AMG 557, AMG 557 Placebo
- First posted
- 2011-07-08
- Last updated
- 2014-01-10
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety evaluation: Subject incidence of treatment-emergent adverse events, vital signs, physical examinations, clinical laboratory safety tests, ECGs, and the incidence of binding and neutralizing antibodies to AMG 557 | 253 Days | |
| Secondary | Determine the pharmacokinetic (PK) profile of AMG 557 after multiple subcutaneous (SC) doses in subacute cutaneous lupus erythematosus (SCLE) subjects. | 253 Days | |
| Secondary | Characterize the mean change and variability in serum SS-A and SS-B autoantibodies. | 253 Days | |
| Secondary | Characterize change in Cutaneous Lupus Erythematosus Disease Area and Severity Index score (CLASI-a) score. | 253 Days |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01389895
GET https://conductscience.org/api/trials/v1/NCT01389895/registered