Trial · NCT01031836
A Study to Evaluate Safety and Tolerability of IV or SC Dose of MEDI-545 in Patients With Systemic Lupus Erythematosus.
NCT01031836, Phase 2, Completed, AstraZeneca; results first posted 2018-11-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Evaluate Safety and Tolerability of IV or SC Dose of MEDI-545 in Patients With Systemic Lupus Erythematosus. Trials, record NCT01031836. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01031836
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate Safety and Tolerability of IV or SC Dose of MEDI-545 in Patients With Systemic Lupus Erythematosus.
- NCT number
- NCT01031836
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 30 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Systemic Lupus Erythematosus
- Interventions
- MEDI-545, MEDI-545, MEDI-545, MEDI-545, MEDI-545, MEDI-545 600
- First posted
- 2009-12-15
- Last updated
- 2018-11-19
- Results first posted
- 2018-11-19
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Each Category of Adverse Events in Stage I | Stage I (up to 1 year) | |
| Primary | Number of Participants in Each Category of Adverse Events (AE) in Stage II | Stage II (1 year to 3.5 years after first dose) | |
| Secondary | Area Undre Curve (AUC) of MEDI-545 After First Dose in Stage I | After first dose in Stage I (0 upto 28 days) | |
| Secondary | AUC0-14 of MEDI-545 After First Dose in Stage I | After first dose in Stage I | Summary of area under the concentration-time curve from zero to Day 14. |
| Secondary | Maximum Observed Concentration (Cmax) of MEDI-545 After First Dose in Stage I | After first dose in Stage I | |
| Secondary | Change From Baseline in 21-gene Signature Fold Change in Stage I | Stage I | 21-gene signature fold change is pharmacodynamics (PD) parameter measuring expression of type I IFN-inducible gene. |
| Secondary | Number of Participants With Positive Anti-drug Antibody (ADA) During Stage I | Stage I |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Area Undre Curve (AUC) of MEDI-545 After First Dose in Stage I | After first dose in Stage I (0 upto 28 days) | Pharmacokinetics (PK) populaton | day*ug/mL | MEDIAN |
| SECONDARY | AUC0-14 of MEDI-545 After First Dose in Stage I | After first dose in Stage I | PK populaton | day*ug/mL | GEOMETRIC_MEAN |
| PRIMARY | Number of Participants With Each Category of Adverse Events in Stage I | Stage I (up to 1 year) | Safety population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Maximum Observed Concentration (Cmax) of MEDI-545 After First Dose in Stage I | After first dose in Stage I | PK populaton | ug/mL | GEOMETRIC_MEAN |
| SECONDARY | Change From Baseline in 21-gene Signature Fold Change in Stage I | Stage I | Safety population | fold change | MEAN |
| SECONDARY | Number of Participants With Positive Anti-drug Antibody (ADA) During Stage I | Stage I | Safety population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants in Each Category of Adverse Events (AE) in Stage II | Stage II (1 year to 3.5 years after first dose) | Safety population | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group120
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Area Undre Curve (AUC) of MEDI-545 After First Dose in Stage I | MEDI-545 1.0 mg/kg IV | 261.98 | Full Range 16.8 | day*ug/mL | |
| Area Undre Curve (AUC) of MEDI-545 After First Dose in Stage I | MEID-545 3.0 mg/kg IV | 647.93 | Full Range 7.4 | day*ug/mL | |
| Area Undre Curve (AUC) of MEDI-545 After First Dose in Stage I | MEDI-545 10.0 mg/kg IV | 3040.83 | Full Range 24.2 | day*ug/mL | |
| Area Undre Curve (AUC) of MEDI-545 After First Dose in Stage I | MEDI-545 100mg SC | 239.16 | Full Range 239.16 to 239.16 | day*ug/mL | |
| Area Undre Curve (AUC) of MEDI-545 After First Dose in Stage I | MEDI-545 600mg IV | 2308.44 | Full Range 2308.44 to 2308.44 | day*ug/mL | |
| Area Undre Curve (AUC) of MEDI-545 After First Dose in Stage I | MEDI-545 1200mg IV | 5235.41 | Full Range 11.6 | day*ug/mL | |
| AUC0-14 of MEDI-545 After First Dose in Stage I | MEDI-545 1.0 mg/kg IV | 151.28 | Geometric Coefficient of Variation 19.3 | day*ug/mL | |
| AUC0-14 of MEDI-545 After First Dose in Stage I | MEID-545 3.0 mg/kg IV | 432.26 | Geometric Coefficient of Variation 11.0 | day*ug/mL | |
| AUC0-14 of MEDI-545 After First Dose in Stage I | MEDI-545 10.0 mg/kg IV | 1728.01 | Geometric Coefficient of Variation 16.8 | day*ug/mL | |
| AUC0-14 of MEDI-545 After First Dose in Stage I | MEDI-545 100mg SC | 128.06 | Geometric Coefficient of Variation 56.1 | day*ug/mL |
1 to 10 of 120Source ClinicalTrials.gov
See all 120 results by groupParticipant flow36
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Stage I | STARTED | MEDI-545 1.0 mg/kg IV | 5 | |
| Stage I | STARTED | MEDI-545 3.0 mg/kg IV | 5 | |
| Stage I | STARTED | MEDI-545 10.0 mg/kg IV | 5 | |
| Stage I | STARTED | MEDI-545 100 mg SC | 5 | |
| Stage I | STARTED | MEDI-545 600 mg IV | 5 | |
| Stage I | STARTED | MEDI-545 1200 mg IV | 5 | |
| Stage I | COMPLETED | MEDI-545 1.0 mg/kg IV | 4 | |
| Stage I | COMPLETED | MEDI-545 3.0 mg/kg IV | 3 | |
| Stage I | COMPLETED | MEDI-545 10.0 mg/kg IV | 5 | |
| Stage I | COMPLETED | MEDI-545 100 mg SC | 5 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 participant flowAdverse events306
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nasopharyngitis | Infections and infestations | MEDI-545 1.0 mg/kg IV | 2 | 5 | |
| other | Nasopharyngitis | Infections and infestations | MEDI-545 3.0 mg/kg IV | 4 | 5 | |
| other | Nasopharyngitis | Infections and infestations | MEDI-545 10.0 mg/kg IV | 3 | 5 | |
| other | Nasopharyngitis | Infections and infestations | MEDI-545 100 mg SC | 3 | 5 | |
| other | Nasopharyngitis | Infections and infestations | MEDI-545 600 mg IV | 4 | 5 | |
| other | Nasopharyngitis | Infections and infestations | MEDI-545 1200 mg IV | 2 | 5 | |
| other | Upper respiratory tract infection | Infections and infestations | MEDI-545 1.0 mg/kg IV | 0 | 5 | |
| other | Upper respiratory tract infection | Infections and infestations | MEDI-545 3.0 mg/kg IV | 1 | 5 | |
| other | Upper respiratory tract infection | Infections and infestations | MEDI-545 10.0 mg/kg IV | 1 | 5 | |
| other | Upper respiratory tract infection | Infections and infestations | MEDI-545 100 mg SC | 1 | 5 |
1 to 10 of 306Source ClinicalTrials.gov
See all 306 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | MEDI-545 1.0 mg/kg IV | 0 | 5 |
| Total, all-cause mortality | MEDI-545 3.0 mg/kg IV | 0 | 5 |
| Total, all-cause mortality | MEDI-545 10.0 mg/kg IV | 0 | 5 |
| Total, all-cause mortality | MEDI-545 100 mg SC | 0 | 5 |
| Total, all-cause mortality | MEDI-545 600 mg IV | 0 | 5 |
| Total, all-cause mortality | MEDI-545 1200 mg IV | 0 | 5 |
| Total, other adverse events | MEDI-545 1.0 mg/kg IV | 5 | 5 |
| Total, other adverse events | MEDI-545 3.0 mg/kg IV | 4 | 5 |
| Total, other adverse events | MEDI-545 10.0 mg/kg IV | 5 | 5 |
| Total, other adverse events | MEDI-545 100 mg SC | 5 | 5 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers0
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/NCT01031836
GET https://conductscience.org/api/trials/v1/NCT01031836/results?page=2