BIIB023 Long-Term Extension Study in Subjects With Lupus Nephritis

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Biogen Idec
ClinicalTrials.gov Identifier:
NCT01930890
First received: August 26, 2013
Last updated: September 16, 2014
Last verified: September 2014
  Purpose

The primary objective of the study is to evaluate the long-term safety and tolerability of BIIB023 in participants with lupus nephritis (LN).


Condition Intervention Phase
Lupus Nephritis
Biological: BIIB023
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Dose-Blinded, 2-Dose Level, Parallel-Group, Multicenter, Long-Term Extension Study to Evaluate the Long-Term Safety, Efficacy, and Immunogenicity of BIIB023 in Subjects With Lupus Nephritis

Resource links provided by NLM:


Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • The number of participants that experience adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: Up to week 108 ] [ Designated as safety issue: Yes ]
  • The number of participants who discontinue study treatment or withdrawal from the study due to an adverse event (AE) [ Time Frame: Up to week 108 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 175
Study Start Date: November 2013
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: January 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BIIB023 low dose + Background Therapy
Participants will receive BIIB023 low dose (3 mg/kg administered via IV infusion every 4 weeks) in addition to background therapy (includes MMF and oral corticosteroids [prednisone or equivalent])
Biological: BIIB023
Low Dose (3 mg/kg) or high dose (20 mg/kg) BIIB023 intravenous (IV) infusion
Other Name: (anti-TWEAK [TNF-related Weak Inducer of Apoptosis] monoclonal antibody)
Experimental: BIIB023 high dose+ Background Therapy
Participants will receive BIIB023 high dose (20 mg/kg administered via IV infusion every 4 weeks) in addition to background therapy (includes MMF and oral corticosteroids [prednisone or equivalent])
Biological: BIIB023
Low Dose (3 mg/kg) or high dose (20 mg/kg) BIIB023 intravenous (IV) infusion
Other Name: (anti-TWEAK [TNF-related Weak Inducer of Apoptosis] monoclonal antibody)

Detailed Description:

This is an extension study for all participants who completed study 211LE201 (NCT01499355) through Week 52 and did not discontinue BIIB023 or placebo. Eligible participants from Study 211LE201 (NCT01499355) will be followed for up to 108 weeks.

Participants who received BIIB023 low dose or high dose in 211LE201 (NCT01499355) will continue to receive the same dosing in 211LE202 in addition to background therapy.

Participants who received placebo in 211LE201 (NCT01499355) are randomized to receive either BIIB023 low dose or high dose in addition to background therapy.

  Eligibility

Ages Eligible for Study:   19 Years to 76 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Subjects who completed Week 52 of Study 211LE201 (NCT01499355) and did not discontinue BIIB023 or placebo study treatment.
  • Subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 6 months after their last dose of study treatment.

Key Exclusion Criteria:

  • Any significant change in medical history in subjects from Study 211LE201 (NCT01499355), including laboratory tests or current clinically significant condition that, in the opinion of the Investigator, would have excluded the subjects' participation. The Investigator must re-review the subject's medical fitness for participation and consider any diseases that would preclude treatment under this protocol.
  • Subjects from Study 211LE201 (NCT01499355) who discontinued BIIB023 or placebo treatment prior to Week 52 of Study 211LE201.
  • Female subjects considering becoming pregnant while in the study, currently pregnant, or breast feeding.
  • Unwillingness or inability to comply with the requirements of the protocol including the presence of any condition (physical, mental, or social) that is likely to affect the subject's ability to comply with the protocol.
  • Other unspecified reasons that, in the opinion of the Investigator or Biogen Idec, makes the subject unsuitable for enrollment.

NOTE: Other Protocol-defined Inclusion/Exclusion Criteria May Apply.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01930890

  Show 73 Study Locations
Sponsors and Collaborators
Biogen Idec
Investigators
Study Director: Medical Director Biogen Idec
  More Information

No publications provided

Responsible Party: Biogen Idec
ClinicalTrials.gov Identifier: NCT01930890     History of Changes
Other Study ID Numbers: 211LE202, 2013-000594-69
Study First Received: August 26, 2013
Last Updated: September 16, 2014
Health Authority: Israel: Ministry of Health
Belgium: Federal Agency for Medicinal Products and Health Products
South Korea: Korea Food and Drug Administration (KFDA)
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Malaysia: National Pharmaceutical Control Bureau
Australia: Department of Health and Ageing Therapeutic Goods Administration
Hong Kong: Department of Health
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Serbia: Medicines and Medical Devices Agency of Serbia
Thailand: Ministry of Public Health
Spain: Spanish Agency of Medicines
Mexico: Federal Commission for Sanitary Risks Protection
Peru: Instituto Nacional de Salud
Hungary: National Institute of Pharmacy
Canada: Health Canada
Philippines: Bureau of Food and Drugs
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
United States: Food and Drug Administration
Portugal: National Authority of Medicines and Health Products, IP (INFARMED)
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Germany: Paul-Ehrlich-Institut
Russia: Ministry of Health of the Russian Federation
Italy: The Italian Medicines Agency

Additional relevant MeSH terms:
Lupus Nephritis
Nephritis
Glomerulonephritis
Kidney Diseases
Urologic Diseases
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on September 18, 2014