A Phase II Study to Evaluate Safety and Efficacy of ALX-0061 in Subjects With Systemic Lupus Erythematosus

NCT02437890 | Completed Phase 2 Results DMC

• 2 other identifiers: ALX0061-C2042015-000372-95
• Study Type: interventional
• Target: 312
• Locations: 17 countries
• Sites: 118

Brief Summary

Primary objective: 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.

Conditions

Lupus Erythematosus, Systemic

Outcome Measures

Primary Outcomes (1)

• Number and Percentage of Subjects Who Achieved a Response at Week 24 According to the Modified British Isles Lupus Assessment Group (BILAG)-Based Composite Lupus Assessment (mBICLA) Score

  The primary endpoint was evaluated by determining if there was a dose-response relationship between the mBICLA response rate at Week 24 and the dose administered, using the Multiple Comparison Procedure - Modelling (MCP-Mod) methodology. The existence of several candidate parametric models was assumed and multiple comparison techniques were used to choose the model(s) most likely to represent the true underlying dose-response curve. The selected model could further be used to guide the choice of adequate doses. mBICLA responders were defined as subjects who met all of the following criteria: 1. BILAG-2004 normal improvement: all A scores at Baseline improved to B, C or D, and all B scores improved to C or D. 2. No worsening in disease activity: no new BILAG-2004 A scores and ≤ 1 new increase to B. 3. No worsening of total mSLEDAI-2K score from Baseline. 4. No significant deterioration (\< 10% worsening from Baseline) in PGA. 5. No treatment failure (including the premature

  At Week 24 visit

Secondary Outcomes (40)

• Number and Percentage of Subjects With mBICLA Response at Week 24 and Week 48

  At Week 24 and Week 48

• Number and Percentage of Subjects With Modified Systemic Lupus Erythematosus Responder Index (mSRI-4) Response at Week 24 and Week 48

  At Week 24 and Week 48

• Number and Percentage of Subjects With mSRI-5 Response at Week 24 and Week 48

  At Week 24 and Week 48

• Number and Percentage of Subjects With mSRI-6 Response at Week 24 and Week 48

  At Week 24 and Week 48

• Number and Percentage of Subjects With mSRI-7 Response at Week 24 and Week 48

  At Week 24 and Week 48

Study Arms (5)

Placebo

PLACEBO COMPARATOR

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.

Biological: Placebo

ALX-0061 75 mg q4w

EXPERIMENTAL

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.

Biological: ALX-0061; Biological: Placebo

ALX-0061 150 mg q4w

EXPERIMENTAL

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.

Biological: ALX-0061; Biological: Placebo

ALX-0061 150 mg q2w

EXPERIMENTAL

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.

Biological: ALX-0061; Biological: Placebo

ALX-0061 225 mg q2w

EXPERIMENTAL

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.

Biological: ALX-0061

Interventions

ALX-0061 BIOLOGICAL

ALX-0061 150 mg q2w; ALX-0061 150 mg q4w; ALX-0061 225 mg q2w; ALX-0061 75 mg q4w

Placebo BIOLOGICAL

ALX-0061 150 mg q2w; ALX-0061 150 mg q4w; ALX-0061 75 mg q4w; Placebo

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Man or woman ≥ 18 years and \< 65 years of age
• 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
• Have moderate to severe active SLE
• Have seropositive disease at screening
• Subject must be at least on one or more of the treatments for SLE as listed in the protocol
• Others as defined in the protocol

You may not qualify if:

• Have an A score on the revised BILAG-2004 other than in the mucocutaneous and/or musculoskeletal system at screening and at baseline for the organ systems that can be clinically assessed
• Have a systemic inflammatory disease other than SLE
• Clinically significant infection treated or needing treatment
• Any active or recurrent viral infection that based on the Investigator´s clinical assessment makes the subject unsuitable for the study
• Have received prior therapy blocking the interleukin-6 (IL-6) pathway
• Others as defined in the protocol

Sponsors & Collaborators

• Ablynx, a Sanofi company: lead

Study Sites (118)

Investigator Site

Birmingham, Alabama, 35294, United States

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Glendale, Arizona, 85306, United States

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Phoenix, Arizona, 85032, United States

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Tucson, Arizona, 85724, United States

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Artesia, California, 90701, United States

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La Jolla, California, 92093, United States

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La Palma, California, 90623, United States

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Los Angeles, California, 90057, United States

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Upland, California, 91786, United States

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Aventura, Florida, 33180, United States

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Clearwater, Florida, 33765, United States

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Orlando, Florida, 32806, United States

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Pinellas Park, Florida, 33781, United States

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Atlanta, Georgia, 30342, United States

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Stockbridge, Georgia, 30281, United States

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Louisville, Kentucky, 40217, United States

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Cumberland, Maryland, 21502, United States

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Lansing, Michigan, 48910, United States

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New York, New York, 10016, United States

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New York, New York, 10032, United States

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Smithtown, New York, 11787, United States

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Syracuse, New York, 13210, United States

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Charlotte, North Carolina, 28210, United States

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Raleigh, North Carolina, 27617, United States

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Pittsburgh, Pennsylvania, 15213, United States

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Jackson, Tennessee, 38305, United States

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Austin, Texas, 78745, United States

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Houston, Texas, 77034, United States

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Caba, Buenos Aires, 1431, Argentina

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Caba, Argentina

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Ciudad Autónoma de Buenos Aire, Argentina

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Córdoba, Argentina

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San Juan, 5400, Argentina

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San Miguel de Tucumán, Argentina

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Santiago, Chile

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Santiago, Chile

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Prague, Czechia

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Berlin, Germany

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Dresden, Germany

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Mainz, Germany

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Mannheim, Germany

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Budapest, Hungary

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Budapest, Hungary

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Debrecen, Hungary

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Gyula, Hungary

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Zalaegerszeg, Hungary

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Guadalajara, Mexico

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Guadalajara, Mexico

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Guadalajara, Mexico

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Mexicali, Mexico

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Mexico City, Mexico

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Mérida, Mexico

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San Luis Potosí City, Mexico

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Lima, Peru

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Lima, Peru

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Lima, Peru

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Lima, Peru

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Cebu City, Philippines

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Cebu City, Philippines

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Lipa City, Philippines

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Makati City, Philippines

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Manila, Philippines

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Quezon City, Philippines

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Bydgoszcz, Poland

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Katowice, Poland

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Lodz, Poland

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Lodz, Poland

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Poznan, Poland

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Poznan, Poland

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Szczecin, Poland

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Almada, Portugal

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Amadora, Portugal

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Lisbon, Portugal

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Ponte de Lima, Portugal

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Porto, Portugal

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Kazan', Russia

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Kemerovo, Russia

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Orenburg, Russia

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Ryazan, Russia

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Saint Petersburg, Russia

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Saint Petersburg, Russia

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Smolensk, Russia

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Vladimir, Russia

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Voronezh, Russia

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Belgrade, Serbia

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Belgrade, Serbia

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Belgrade, Serbia

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Belgrade, Serbia

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Belgrade, Serbia

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Niška Banja, Serbia

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Daegu, South Korea

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Gwangju, South Korea

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Seoul, South Korea

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Seoul, South Korea

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A Coruña, Spain

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Barcelona, Spain

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Barcelona, Spain

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Barcelona, Spain

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Bilbao, Spain

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Madrid, Spain

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Madrid, Spain

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Sant Joan Despí, Spain

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Kaohsiung City, Taiwan

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Taichung, Taiwan

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Taichung, Taiwan

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Taipei, Taiwan

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Taoyuan District, Taiwan

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Ivano-Frankivsk, Ukraine

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Kharkiv, Ukraine

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Kryvyi Rih, Ukraine

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Kyiv, Ukraine

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Kyiv, Ukraine

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Kyiv, Ukraine

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Lviv, Ukraine

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Poltava, Ukraine

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Poltava, Ukraine

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Vinnytsia, Ukraine

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Vinnytsia, Ukraine

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Related Publications (1)

• 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.

  PMID: 33687069 DERIVED

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

ALX-0061

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Medical Monitor
• Organization: Ablynx

clinicaltrials@ablynx.com

+32 (9) 262 00 00

Study Officials

• Medical Lead

  Ablynx NV

  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: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2015
• First Posted: May 8, 2015
• Study Start: July 1, 2015
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: February 26, 2019
• Results First Posted: February 6, 2019

Record last verified: 2019-02

Locations

TW (5); CL (2); PL (7); PT (5); PE (4); ME (7); PH (6); US (28); SE (6); UA (11); HU (5); CZ (1); KR (4); AR (6); RU (9); ES (8); DE (4)