A Phase II Study to Evaluate Safety and Efficacy of ALX-0061 in Subjects With Systemic Lupus Erythematosus
NCT ID: NCT02437890
Last Updated: 2019-02-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
312 participants
INTERVENTIONAL
2015-07-31
2018-01-31
Brief Summary
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To assess the efficacy and safety of different dose regimens of ALX-0061 administered subcutaneously (s.c.) to subjects with moderate to severe active, seropositive systemic lupus erythematosus (SLE) compared to placebo.
Secondary objectives:
To assess the pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, flare rate, steroid reduction and health-related quality of life, with different dose regimens of ALX-0061.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Two s.c. injections with placebo every 2 weeks (q2w).
\*\*\*
Placebo was supplied as a sterile liquid for s.c. injection at a volume of 0.5 mL and 1.0 mL in pre-filled single-use syringes. To maintain the blind, subjects randomly assigned to the placebo group received 2 s.c. injections q2w:
Syringe A with placebo (1 mL) q2w starting at Day 1, up to and including Week 46.
Syringe B with placebo (0.5 mL) q2w starting at Day 1, up to and including Week 46.
Placebo
ALX-0061 75 mg q4w
ALX-0061 75 mg every 4 weeks (q4w).
\*\*\*
Vobarilizumab (ALX-0061) and placebo were supplied as a sterile liquid for s.c. injection at a volume of 0.5 mL and 1.0 mL in pre-filled single-use syringes. To maintain the blind, subjects randomly assigned to ALX-0061 75 mg q4w received 2 s.c. injections q2w:
Syringe A with placebo (1 mL) q2w starting at Day 1, up to and including Week 46.
Syringe B with ALX-0061 (0.5 mL) q4w at Day 1, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44, and syringe B with placebo (0.5 mL) q4w at Weeks 2, 6, 10, 14, 18, 22, 26, 30, 34, 38, 42, and 46.
ALX-0061
Placebo
ALX-0061 150 mg q4w
ALX-0061 150 mg every 4 weeks (q4w).
\*\*\*
Vobarilizumab (ALX-0061) and placebo were supplied as a sterile liquid for s.c. injection at a volume of 0.5 mL and 1.0 mL in pre-filled single-use syringes. To maintain the blind, subjects randomly assigned to ALX-0061 150 mg q4w received 2 s.c. injections q2w:
Syringe A with ALX-0061 (1 mL) q4w at Day 1, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44, and syringe A with placebo (1 mL) q4w at Weeks 2, 6, 10, 14, 18, 22, 26, 30, 34, 38, 42, and 46.
Syringe B with placebo (0.5 mL) q2w starting at Day 1, up to and including Week 46.
ALX-0061
Placebo
ALX-0061 150 mg q2w
ALX-0061 150 mg every 2 weeks (q2w).
\*\*\*
Vobarilizumab (ALX-0061) and placebo were supplied as a sterile liquid for s.c. injection at a volume of 0.5 mL and 1.0 mL in pre-filled single-use syringes. To maintain the blind, subjects randomly assigned to ALX-0061 150 mg q2w received 2 s.c. injections q2w:
Syringe A with ALX-0061 (1 mL) q2w starting at Day 1, up to and including Week 46.
Syringe B with placebo (0.5 mL) q2w starting at Day 1, up to and including Week 46.
ALX-0061
Placebo
ALX-0061 225 mg q2w
ALX-0061 225 mg every 2 weeks (q2w).
\*\*\*
Vobarilizumab (ALX-0061) was supplied as a sterile liquid for s.c. injection at a volume of 0.5 mL and 1.0 mL in pre-filled single-use syringes. To maintain the blind, subjects randomly assigned to ALX-0061 225 mg q2w received 2 s.c. injections q2w:
Syringe A with ALX-0061 (1 mL) q2w starting at Day 1, up to and including Week 46.
Syringe B with ALX-0061 (0.5 mL) q2w starting at Day 1, up to and including Week 46.
ALX-0061
Interventions
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ALX-0061
Placebo
Eligibility Criteria
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Inclusion Criteria
2. Have a diagnosis of SLE for at least 6 months prior to screening and fulfill the 1997 American College of Rheumatology (ACR) or 2012 Systemic Lupus International Collaborating Clinics (SLICC) classification criteria
3. Have moderate to severe active SLE
4. Have seropositive disease at screening
5. Subject must be at least on one or more of the treatments for SLE as listed in the protocol
6. Others as defined in the protocol
Exclusion Criteria
2. Have a systemic inflammatory disease other than SLE
3. Clinically significant infection treated or needing treatment
4. Any active or recurrent viral infection that based on the Investigator´s clinical assessment makes the subject unsuitable for the study
5. Have received prior therapy blocking the interleukin-6 (IL-6) pathway
6. Others as defined in the protocol
18 Years
64 Years
ALL
No
Sponsors
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Ablynx, a Sanofi company
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Lead
Role: STUDY_DIRECTOR
Ablynx NV
Locations
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Investigator Site
Birmingham, Alabama, United States
Investigator Site
Glendale, Arizona, United States
Investigator Site
Phoenix, Arizona, United States
Investigator Site
Tucson, Arizona, United States
Investigator Site
Artesia, California, United States
Investigator Site
La Jolla, California, United States
Investigator Site
La Palma, California, United States
Investigator Site
Los Angeles, California, United States
Investigator Site
Upland, California, United States
Investigator Site
Aventura, Florida, United States
Investigator Site
Clearwater, Florida, United States
Investigator Site
Orlando, Florida, United States
Investigator Site
Pinellas Park, Florida, United States
Investigator Site
Atlanta, Georgia, United States
Investigator Site
Stockbridge, Georgia, United States
Investigator Site
Louisville, Kentucky, United States
Investigator Site
Cumberland, Maryland, United States
Investigator Site
Lansing, Michigan, United States
Investigator Site
New York, New York, United States
Investigator Site
New York, New York, United States
Investigator Site
Smithtown, New York, United States
Investigator Site
Syracuse, New York, United States
Investigator Site
Charlotte, North Carolina, United States
Investigator Site
Raleigh, North Carolina, United States
Investigator Site
Pittsburgh, Pennsylvania, United States
Investigator Site
Jackson, Tennessee, United States
Investigator Site
Austin, Texas, United States
Investigator Site
Houston, Texas, United States
Investigator Site
Caba, Buenos Aires, Argentina
Investigator Site
Caba, , Argentina
Investigator Site
Ciudad Autónoma de Buenos Aire, , Argentina
Investigator Site
Córdoba, , Argentina
Investigator Site
San Juan, , Argentina
Investigator Site
San Miguel de Tucumán, , Argentina
Investigator Site 1
Santiago, , Chile
Investigator Site 2
Santiago, , Chile
Investigator Site
Prague, , Czechia
Investigator Site
Berlin, , Germany
Investigator Site
Dresden, , Germany
Investigator Site
Mainz, , Germany
Investigator Site
Mannheim, , Germany
Investigator Site 1
Budapest, , Hungary
Investigator Site 2
Budapest, , Hungary
Investigator Site
Debrecen, , Hungary
Investigator Site
Gyula, , Hungary
Investigator Site
Zalaegerszeg, , Hungary
Investigator Site 1
Guadalajara, , Mexico
Investigator Site 2
Guadalajara, , Mexico
Investigator Site 3
Guadalajara, , Mexico
Investigator Site
Mexicali, , Mexico
Investigator Site
Mexico City, , Mexico
Investigator Site
Mérida, , Mexico
Investigator Site
San Luis Potosí City, , Mexico
Investigator Site 1
Lima, , Peru
Investigator Site 2
Lima, , Peru
Investigator Site 3
Lima, , Peru
Investigator Site 4
Lima, , Peru
Investigator Site 1
Cebu City, , Philippines
Investigator Site 2
Cebu City, , Philippines
Investigator Site
Lipa City, , Philippines
Investigator Site
Makati City, , Philippines
Investigator Site
Manila, , Philippines
Investigator Site
Quezon City, , Philippines
Investigator Site
Bydgoszcz, , Poland
Investigator Site
Katowice, , Poland
Investigator Site 1
Lodz, , Poland
Investigator Site 2
Lodz, , Poland
Investigator Site 1
Poznan, , Poland
Investigator Site 2
Poznan, , Poland
Investigator Site
Szczecin, , Poland
Investigator Site
Almada, , Portugal
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Amadora, , Portugal
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Lisbon, , Portugal
Investigator Site
Ponte de Lima, , Portugal
Investigator Site
Porto, , Portugal
Investigator Site
Kazan', , Russia
Investigator Site
Kemerovo, , Russia
Investigator Site
Orenburg, , Russia
Investigator Site
Ryazan, , Russia
Investigator Site 1
Saint Petersburg, , Russia
Investigator Site 2
Saint Petersburg, , Russia
Investigator Site
Smolensk, , Russia
Investigator Site
Vladimir, , Russia
Investigator Site
Voronezh, , Russia
Investigator Site 1
Belgrade, , Serbia
Investigator Site 2
Belgrade, , Serbia
Investigator Site 3
Belgrade, , Serbia
Investigator Site 4
Belgrade, , Serbia
Investigator Site 5
Belgrade, , Serbia
Investigator Site
Niška Banja, , Serbia
Investigator Site
Daegu, , South Korea
Investigator Site
Gwangju, , South Korea
Investigator Site 1
Seoul, , South Korea
Investigator Site 2
Seoul, , South Korea
Investigator Site
A Coruña, , Spain
Investigator Site 1
Barcelona, , Spain
Investigator Site 2
Barcelona, , Spain
Investigator Site 3
Barcelona, , Spain
Investigator Site
Bilbao, , Spain
Investigator Site 1
Madrid, , Spain
Investigator Site 2
Madrid, , Spain
Investigator Site
Sant Joan Despí, , Spain
Investigator Site
Kaohsiung City, , Taiwan
Investigator Site 1
Taichung, , Taiwan
Investigator Site 2
Taichung, , Taiwan
Investigator Site
Taipei, , Taiwan
Investigator Site
Taoyuan District, , Taiwan
Investigator Site
Ivano-Frankivsk, , Ukraine
Investigator Site
Kharkiv, , Ukraine
Investigator Site
Kryvyi Rih, , Ukraine
Investigator Site 1
Kyiv, , Ukraine
Investigator Site 2
Kyiv, , Ukraine
Investigator Site 3
Kyiv, , Ukraine
Investigator Site
Lviv, , Ukraine
Investigator Site 1
Poltava, , Ukraine
Investigator Site 2
Poltava, , Ukraine
Investigator Site 1
Vinnytsia, , Ukraine
Investigator Site 2
Vinnytsia, , Ukraine
Countries
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References
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Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2015-000372-95
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ALX0061-C204
Identifier Type: -
Identifier Source: org_study_id
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