A Phase 2, Open-label Extension Study to Evaluate Long-term Safety of MEDI-546 in Adults with Systemic Lupus Erythematosus

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-004619-30-HU

Enrollment

240

Registered

2013-06-28

Start date

2013-08-27

Completion date

Unknown

Last updated

2021-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic Lupus Erythematosus MedDRA version: 18.0 Level: PT Classification code 10042945 Term: Systemic lupus erythematosus System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Interventions

Product Name: anifrolumab Product Code: Medi-546 Pharmaceutical Form: Solution for infusion INN or Proposed INN: anifrolumab Current Sponsor code: MEDI-546 Concentration unit: mg/ml milligram(s)/milli

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Must provide written informed consent Must have qualified for and completed study CD-IA-MEDI-546-1013 Must be willing to use 2 methods of effective contraception Must have adequate venous access Must be willing to forego other forms of experimental treatment Must be able to complete the study period. Has adequate reading and writing abilities to comprehend and complete the informed consent, and all protocol-related subject assessments. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 228 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 12

Exclusion criteria

Exclusion criteria: -Any concurrent condition that in the opinion of the investigator would interfere with the evaluation of the investigational product -Major surgery within 8 weeks before signing ICF -Concomitant medications within the last 12 weeks: Azathioprine greater than 200mg/day, Mycophenolate mofetil/mycophenolic acid greater than 2.0g/day, oral, sc, or intramuscular methotrexate greater than 25mg/week - Receipt of a live or attenuated vaccine within 4 weeks of signing the ICF -Receipt of Bacillus of Calmette and Guerin (BCG) vaccine within 1 year of ICF

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the long-term safety and tolerability of intravenous (IV) MEDI-546 in adult subjects with chronic, moderately-to-severely active systemic lupus erythematosus (SLE).;Secondary Objective: To evaluate the immunogenicity (IM) of MEDI-546. ;Primary end point(s): The safety and tolerability of MEDI-546 will be assessed primarily by summarizing treatment-emergent adverse events and treatment emergent serious adverse events;Timepoint(s) of evaluation of this end point: Although no formal interim analyses of the study period data are planned, analyses of the accumulating data during the study period may be performed to assess the ongoing safety and risk/benefit of the study treatment and to assist with Phase 3 planning. The final analysis of the study period data will take place after the last on-study subject completes the study period follow-up visit or discontinues from the study.	—

Measure

Time frame

Main Objective: To evaluate the long-term safety and tolerability of intravenous (IV) MEDI-546 in adult subjects with chronic, moderately-to-severely active systemic lupus erythematosus (SLE).;Secondary Objective: To evaluate the immunogenicity (IM) of MEDI-546. ;Primary end point(s): The safety and tolerability of MEDI-546 will be assessed primarily by summarizing treatment-emergent adverse events and treatment emergent serious adverse events;Timepoint(s) of evaluation of this end point: Although no formal interim analyses of the study period data are planned, analyses of the accumulating data during the study period may be performed to assess the ongoing safety and risk/benefit of the study treatment and to assist with Phase 3 planning. The final analysis of the study period data will take place after the last on-study subject completes the study period follow-up visit or discontinues from the study.

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Secondary

Measure	Time frame
Secondary end point(s): The secondary objective of this study is to evaluate the IM of MEDI-546. Immunogenicity results will be analyzed by summarizing the number and percentage of subjects who develop detectable ADAs.;Timepoint(s) of evaluation of this end point: Although no formal interim analyses of the study period data are planned, analyses of the accumulating data during the study period may be performed to assess the ongoing safety and risk/benefit of the study treatment and to assist with Phase 3 planning. The final analysis of the study period data will take place after the last on-study subject completes the study period follow-up visit or discontinues from the study.	—

Measure

Time frame

Secondary end point(s): The secondary objective of this study is to evaluate the IM of MEDI-546. Immunogenicity results will be analyzed by summarizing the number and percentage of subjects who develop detectable ADAs.;Timepoint(s) of evaluation of this end point: Although no formal interim analyses of the study period data are planned, analyses of the accumulating data during the study period may be performed to assess the ongoing safety and risk/benefit of the study treatment and to assist with Phase 3 planning. The final analysis of the study period data will take place after the last on-study subject completes the study period follow-up visit or discontinues from the study.

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Countries

Brazil, Bulgaria, Colombia, Czech Republic, Hungary, Korea, Republic of, Mexico, Peru, Poland, Romania, Taiwan, Ukraine, United States

Contacts

Public ContactClinical Trials Enquiries

Medimmune LLC

clinicaltrialenquiries@medimmune.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026