BIIB023 Long-Term Extension Study in Subjects With Lupus Nephritis

NCT01930890 | Terminated Phase 2 Results DMC

• 2 other identifiers: 211LE2022013-000594-69
• Study Type: interventional
• Target: 87
• Locations: 19 countries
• Sites: 33

Brief Summary

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

Conditions

Lupus Nephritis

Outcome Measures

Primary Outcomes (2)

• Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)

  AEs with a start date on or after the first dose date in study 211LE202. AE: any untoward medical occurrence that does not necessarily have a causal relationship with this treatment. SAE: any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the subject at immediate risk of death (a life-threatening event); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; or results in a congenital anomaly/birth defect. An SAE may also be any other medically important event that, in the opinion of the Investigator, may jeopardize the subject or may require intervention to prevent one of the other outcomes listed above.

  Up to Week 108

• Number of Participants Who Discontinued Study Treatment or Withdrew From Study Due to an AE

  AEs with a start date on or after the first dose date in study 211LE202. AE: any untoward medical occurrence that does not necessarily have a causal relationship with this treatment. SAE: any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the subject at immediate risk of death (a life-threatening event); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; or results in a congenital anomaly/birth defect. An SAE may also be any other medically important event that, in the opinion of the Investigator, may jeopardize the subject or may require intervention to prevent one of the other outcomes listed above.

  Up to Week 108

Study Arms (2)

BIIB023 3 mg/kg

EXPERIMENTAL

Participants will receive BIIB023 3 mg/kg IV every 4 weeks through Week 100 plus background therapy including oral steroids (prednisone or equivalent) and mycophenolate mofetil (MMF).

Biological: BIIB023; Drug: mycophenolate mofetil; Drug: oral corticosteroids

BIIB023 20 mg/kg

EXPERIMENTAL

Participants will receive BIIB023 20 mg/kg IV every 4 weeks through Week 100 plus background therapy including oral steroids (prednisone or equivalent) and MMF.

Biological: BIIB023; Drug: mycophenolate mofetil; Drug: oral corticosteroids

Interventions

BIIB023 BIOLOGICAL

BIIB023 20 mg/kg; BIIB023 3 mg/kg

mycophenolate mofetil DRUG

titrated to a target daily dose of 2 g (1 g twice daily)

Also known as: MMF, Cellcept

BIIB023 20 mg/kg; BIIB023 3 mg/kg

oral corticosteroids DRUG

oral corticosteroids (prednisone or equivalent) at a target prednisone dose of 10 mg/day

BIIB023 20 mg/kg; BIIB023 3 mg/kg

Eligibility Criteria

• Age: 19 Years - 76 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Any significant change in medical history in subjects from Study 211LE201, 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 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, makes the subject unsuitable for enrollment.

Sponsors & Collaborators

• Biogen: lead

Study Sites (33)

Research Site

Lake Success, New York, 11020, United States

Location

Research Site

Columbus, Ohio, 43210, United States

Location

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Memphis, Tennessee, 38119, United States

Location

Research Site

El Paso, Texas, 79905, United States

Location

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Ciudad Autonoma Buenos Aires, Ciudad Autonoma Buenos Aires, Argentina

Location

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San Juan, San Juan Province, Argentina

Location

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San Miguel de Tucumán, Tucumán Province, Argentina

Location

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Melbourne, Victoria, 3052, Australia

Location

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Leuven, 3000, Belgium

Location

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Liège, 4000, Belgium

Location

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Cuiabá, Mato Grosso, 78040-360, Brazil

Location

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Barranquilla, Colombia

Location

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Bogotá, Colombia

Location

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Medellín, Colombia

Location

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Pessac, Gironde, 33604, France

Location

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Paris, Paris Cedex 13, 75651, France

Location

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Shatin, Hong Kong

Location

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Debrecen, 4032, Hungary

Location

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Pisa, Pisa, 56126, Italy

Location

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Kuala Lumpur, Kuala Lumpur, 59100, Malaysia

Location

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Kuching, Sarawak, 93586, Malaysia

Location

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Kuala Selangor, 41200, Malaysia

Location

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Kuala Selangor, 43000, Malaysia

Location

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Cuauhtémoc, Mexico City, 06090, Mexico

Location

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Lima, Peru

Location

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Manila, 1008, Philippines

Location

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Quezon City, 1102, Philippines

Location

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Lodz, 90-153, Poland

Location

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Moscow, 123182, Russia

Location

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Suwon, Gyeonggi-do, 443-380, South Korea

Location

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Sagunto, Valencia, 46520, Spain

Location

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Bangkoknoi, Bangkok, 10700, Thailand

Location

Research Site

Pathumwan, Bangkok, 10330, Thailand

Location

MeSH Terms

Conditions

Lupus Nephritis

Interventions

BIIB023; Mycophenolic Acid; Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lupus Erythematosus, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids; Lipids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Limitations and Caveats

Study was terminated based on the pre-specified, blinded futility analysis of Study 211LE201 (NCT01499355), which did not demonstrate sufficient efficacy to warrant continuation of the studies. Study was not terminated based on safety considerations.

Results Point of Contact

• Title: Biogen Study Medical Director
• Organization: Biogen

clinicaltrials@biogen.com

Study Officials

• Medical Director

  Biogen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2013
• First Posted: August 29, 2013
• Study Start: November 1, 2013
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: January 18, 2017
• Results First Posted: January 18, 2017

Record last verified: 2016-11

Locations

PH (2); KR (1); TH (2); BR (1); PE (1); CO (3); HK (1); PL (1); AR (3); BE (2); HU (1); US (4); FR (2); IT (1); ME (1); ES (1); RU (1); AU (1); MY (4)