BIIB023 Long-Term Extension Study in Subjects With Lupus Nephritis

Lupus Nephritis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01930890
• Other study ID #: 211LE202
• Secondary ID: 2013-000594-69
• Status: Terminated
• Phase: Phase 2
• First received: August 26, 2013
• Last updated: July 28, 2016
• Start date: November 2013
• Est. completion date: January 2016

Study information

• Verified date: July 2016
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of HealthBelgium: Federal Agency for Medicinal Products and Health ProductsSouth Korea: Korea Food and Drug Administration (KFDA)France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Malaysia: National Pharmaceutical Control BureauAustralia: Department of Health and Ageing Therapeutic Goods AdministrationHong Kong: Department of HealthColombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y AlimentosSerbia: Medicines and Medical Devices Agency of SerbiaThailand: Ministry of Public HealthSpain: Spanish Agency of MedicinesMexico: Federal Commission for Sanitary Risks ProtectionPeru: Instituto Nacional de SaludHungary: National Institute of PharmacyCanada: Health CanadaPhilippines: Bureau of Food and DrugsPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsUnited States: Food and Drug AdministrationPortugal: National Authority of Medicines and Health Products, IP (INFARMED)Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaGermany: Paul-Ehrlich-InstitutRussia: Ministry of Health of the Russian FederationItaly: The Italian Medicines Agency
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 87
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 76 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lupus Nephritis
• Nephritis

Intervention

Biological:
• BIIB023
As specified in the treatment arm

Drug:
• Background therapy
Includes mycophenolate mofetil (MMF) titrated to a target daily dose of 2 g (1 g twice daily) and oral corticosteroids (prednisone or equivalent) at a target prednisone dose of 10 mg/day

Locations

Country	Name	City	State
Argentina	Research Site	Ciudad Autonoma Buenos Aires
Argentina	Research Site	San Juan
Argentina	Research Site	San Miguel de Tucuman	Tucuman
Australia	Research Site	Melbourne	Victoria
Belgium	Research Site	Leuven
Belgium	Research Site	Liège
Brazil	Research Site	Cuiabá	Mato Grosso
Colombia	Research Site	Barranquilla
Colombia	Research Site	Bogota
Colombia	Research Site	Medellín
France	Research Site	Paris	Paris cedex 13
France	Research Site	Pessac	Gironde
Hong Kong	Research Site	Hong Kong
Hungary	Research Site	Debrecen
Italy	Research Site	Pisa
Korea, Republic of	Research Site	Suwon-si	Gyeonggi-do
Malaysia	Research Site	Klang	Selangor
Malaysia	Research Site	Kuala Lumpur
Malaysia	Research Site	Kuching	Sarawak
Malaysia	Research Site	Selangor
Mexico	Research Site	Cuauhtemoc	Distrito Federal
Peru	Research Site	Lima
Philippines	Research Site	Manila
Philippines	Research Site	Quezon City
Poland	Research Site	Lodz
Russian Federation	Research Site	Moscow
Spain	Research Site	Sagunto	Valencia
Thailand	Research Site	Bangkoknoi	Bangkok
Thailand	Research Site	Pathumwan	Bangkok
United States	Research Site	Columbus	Ohio
United States	Research Site	El Paso	Texas
United States	Research Site	Great Neck	New York
United States	Research Site	Memphis	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Belgium,  Brazil,  Colombia,  France,  Hong Kong,  Hungary,  Italy,  Korea, Republic of,  Malaysia,  Mexico,  Peru,  Philippines,  Poland,  Russian Federation,  Spain,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of participants that experience adverse events (AEs) and serious adverse events (SAEs)		Up to week 108	Yes
Primary	The number of participants who discontinue study treatment or withdrawal from the study due to an adverse event (AE)		Up to week 108	Yes