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

Primary Purpose

Lupus Erythematosus, Systemic

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

ALX-0061

Placebo

About this trial

This is an interventional treatment trial for Lupus Erythematosus, Systemic

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

ALX-0061 75 mg q4w

ALX-0061 150 mg q4w

ALX-0061 150 mg q2w

ALX-0061 225 mg q2w

Arm Description

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.

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 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 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 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.

Outcomes

Primary Outcome Measures

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: BILAG-2004 normal improvement: all A scores at Baseline improved to B, C or D, and all B scores improved to C or D. No worsening in disease activity: no new BILAG-2004 A scores and ≤ 1 new increase to B. No worsening of total mSLEDAI-2K score from Baseline. No significant deterioration (< 10% worsening from Baseline) in PGA. No treatment failure (including the premature

Secondary Outcome Measures

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

Number and percentage of mBICLA responders 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

The composite index mSRI-4 enables quantification of decrease and increase in disease activity in a broad spectrum of manifestations thereby offering a comprehensive assessment of SLE disease status. mSRI combines advantages from 3 validated measurement tools. The mSRI-4 criteria for response are: modified SLE disease activity index 2000 (mSLEDAI-2K): ≥ 4 point reduction (covers global disease improvement), British Isles Lupus Assessment Group 2004 (BILAG-2004): no new A domain score and no more than 1 new increase to B (covers organ-specific disease improvement), Physician's Global Assessment (PGA) (is used as validity and safety net for items that were not addressed by the other two indices): < 10% increase from Baseline (no worsening) When all 3 criteria are met, the subject is a mSRI-4 responder at that time point. Subjects who were treatment failures or discontinued from treatment were considered non-responder after treatment failure/discontinuation.

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

The mSRI-5 criteria for response are: mSLEDAI-2K: ≥ 5 point reduction BILAG-2004: no new A domain score and no more than 1 new increase to B domain score PGA: no worsening (< 10% increase from Baseline) Only subjects with Baseline mSLEDAI-2K ≥ 5 were considered for the derivation of that endpoint. Subjects who were treatment failures or discontinued from treatment were considered non-responder after treatment failure/discontinuation.

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

The mSRI-6 criteria for response are: mSLEDAI-2K: ≥ 6 point reduction BILAG-2004: no new A domain score and no more than 1 new increase to B domain score PGA: no worsening (< 10% increase from Baseline) Only subjects with Baseline mSLEDAI-2K ≥ 6 were considered for the derivation of that endpoint. Subjects who were treatment failures or discontinued from treatment were considered non-responder after treatment failure/discontinuation

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

The mSRI-7 criteria for response are: mSLEDAI-2K: ≥ 7 point reduction BILAG-2004: no new A domain score and no more than 1 new increase to B domain score PGA: no worsening (< 10% increase from Baseline) Only subjects with Baseline mSLEDAI-2K ≥ 7 were considered for the derivation of that endpoint. Subjects who were treatment failures or discontinued from treatment were considered non-responder after treatment failure/discontinuation.

Number and Percentage of Subjects With mSRI-8 Response at Week 24 and Week 48.

The mSRI-8 criteria for response are: mSLEDAI-2K: ≥ 8 point reduction BILAG-2004: no new A domain score and no more than 1 new increase to B domain score PGA: no worsening (< 10% increase from Baseline) Only subjects with Baseline mSLEDAI-2K ≥ 8 were considered for the derivation of that endpoint. Subjects who were treatment failures or discontinued from treatment were considered non-responder after treatment failure/discontinuation.

Change From Baseline in Modified Systemic Lupus Erythematosus Disease Activity Index 2000 (mSLEDAI-2K) Score at Week 24 and Week 48

The Systemic Lupus Erythematosus Disease Activity Index 2000 is a 1-page weighted score for 24 items (seizure, psychosis, organic brain syndrome, visual disturbance, cranial nerve disorder, lupus headache, cerebrovascular accident, vasculitis, arthritis, myositis, urinary casts, hematuria, proteinuria, pyuria, rash, alopecia, mucosal ulcers, pleurisy, pericarditis, low complement, etc). The manifestations felt to be most commonly contributing to disease activity are included and scored based on the presence (= 1 multiplied by weight) or absence (= 0) within 30 days prior to the evaluation. The total score ranges from 0-105 (= sum of individual scores), with 105 being higher disease activity. mSLEDAI-2K derives from the standard index by omitting low complement. Mean changes from baseline were derived from an ANCOVA model with treatment as factor and baseline mSLEDAI-2K Score and geographic region as covariates. A negative change from baseline reflects an improvement.

Number and Percentage of Subjects With BILAG-2004 Normal Improvement at Week 24 and Week 48

Normal Improvement: all A scores at baseline improved to B/C/D, and all B scores improved to C or D. Only subjects with non-missing BILAG-2004 who had at least one A or B score at Baseline were assessed for this endpoint

Number and Percentage of Subjects With BILAG-2004 Enhanced Improvement at Week 24 and Week 48

Enhanced improvement: all A scores at baseline improved to B/C/D, and all B scores improved to C or D and no worsening between consecutive visits from baseline up to the considered visit Only subjects with non-missing BILAG-2004 who had at least one A or B score at Baseline were assessed for this endpoint

BILAG-2004 Total Score at Baseline, Week 24 and Week 48

The British Isles Lupus Assessment Group 2004 (BILAG-2004) is a comprehensive composite clinical index that has been developed based on the principle of a physician's intention to treat using a nominal consensus approach. In the index, the nine systems (not organs) considered are: constitutional, mucocutaneous, neuropsychiatric, musculoskeletal, cardiorespiratory, gastrointestinal, renal, ophthalmic and hematological. Disease activity in each of the nine systems is categorized into five levels: grades A (= severe disease activity requiring systemic high dose oral corticosteroids, i.v. pulse corticosteroids, etc.) to E (= system never involved). BILAG total score is derived by assigning the following value to each grade and summing the sores over all organ systems: A = 12, B = 8, C = 1, D/E = 0. The total score ranges from 0-108, with 108 representing high disease activity in all 9 systems requiring high doses of corticosteroids, starting/increasing immunosuppressive drugs, etc.

Number and Percentage of Subjects With BILAG-2004 Normal Improvement in Mucocutaneous System at Week 24 and Week 48

An improvement is defined as an A score at Baseline improved to B/C/D, or a B score improved to C or D. Only subjects with non-missing BILAG-2004 who had at least one A or B score at Baseline were assessed for this endpoint

Number and Percentage of Subjects With BILAG-2004 Normal Improvement in Musculoskeletal System at Week 24 and Week 48

Number and Percentage of Subjects With Persistent Minimal or no Activity in 9 Organ Systems According to BILAG-2004 Systems Tally at Week 24 and Week 48

Change From Baseline in Physician's Global Assessment (PGA) at Week 24 and Week 48

The physician makes a mark between 0 ("no disease") and 100 mm ("severe disease") on the visual analogue scale (VAS) to indicate disease activity (independent of the subject's self-assessment). Mean changes from baseline were derived from an analysis of covariance (ANCOVA) model with treatment as factor and baseline PGA score and geographic region as covariates. A negative change from baseline reflects an improvement.

Change From Baseline in Patient's Global Assessment at Week 24 and Week 48

The subject makes a mark between 0 ("very good") and 100 mm ("very bad") on the VAS to indicate how the subject is doing, while considering all the ways SLE affects him/her. Mean changes from baseline were derived from an analysis of covariance (ANCOVA) model with treatment as factor and baseline Patient's Global Assessment and geographic region as covariates. A negative change from baseline reflects an improvement.

Change From Baseline in Proteinuria at Week 24 and Week 48

Mean changes from baseline were derived from an analysis of covariance (ANCOVA) model with treatment as factor and baseline proteinuria and geographic region as covariates

Number of Subjects Who Were Treatment-emergent Urine Sediment Positive at Week 24 and Week 48

Efficacy Laboratory Parameters (Urinalysis) - Active Urine Sediment Number of subjects who were urine sediment negative at Baseline, but positive at Week 24 and Week 48, respectively.

Change From Baseline in Serum Creatinine at Week 24 and Week 48

Mean changes from baseline were derived from an analysis of covariance (ANCOVA) model with treatment as factor and baseline serum creatinine and geographic region as covariates

Change From Baseline in Creatinine Clearance Estimation (eGFR) at Week 24 and Week 48

Mean changes from baseline were derived from an analysis of covariance (ANCOVA) model with treatment as factor and baseline eGFR and geographic region as covariates

Number of and Percentage Treatment Failures From Baseline to Week 24 and Week 48

Defined as non-protocol allowed increase in steroid dose, start i.v. or i.m. steroids, or start or increase of immunosuppressant

Number and Percentage of Subjects Experiencing Severe Flares According to BILAG-2004 Flare Index From Baseline to Week 24 and Week 48

Number and Percentage of Subjects Experiencing Severe Flares According to mSLEDAI-2K Flare Index (mSFI) From Baseline to Week 24 and Week 48

Percent Change From Baseline in Daily Dose of Steroids at Week 24 and Week 48

Mean changes from baseline were derived from an analysis of covariance (ANCOVA) model with treatment as factor and baseline prednisone equivalent total daily dose and geographic region as covariates

Number and Percentage of Subjects Whose Daily Dose of Steroids Was Reduced Without Severe Flares During Weeks 40-48

Number and percentage of subjects whose prednisone equivalent dose was >7.5 mg/day at baseline and reduced to ≤7.5 mg/day during Weeks 40-48 without experiencing a BILAG-2004-defined or mSFI-defined severe flare after the first prednisone equivalent dose decrease.

Number and Percentage of Subjects Who Discontinued Prednisone (or Equivalent) by Week 48 Without Experiencing a Severe Flare

Number and percentage of subjects who discontinued Prednisone (or equivalent) by Week 48 without experiencing a BILAG-2004-defined or mSFI-defined severe flare

Change From Baseline in Physical Component Scores of Short Form (36) Health Survey (SF-36) at Week 24 and Week 48

The Short Form (36) Health Survey (SF-36) consists of 36 items that can be summarized into 8 domains: physical functioning, role limitations due to physical health problems (role-physical), bodily pain, general health, vitality, social functioning, role limitations due to emotional problems (role-emotional), and mental health. Two summary measures, the physical component summary and the mental component summary, can be derived based on these domain scores. Each score is directly transformed into a 0-100 score on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability. Mean changes from baseline were derived from an analysis of covariance (ANCOVA) model with treatment as factor and baseline SF-36 Score and geographic region as covariates. A positive change denotes an improvement.

Change From Baseline in Mental Component Scores of SF-36 at Week 24 and Week 48

Change From Baseline in 28 Joint Count Swollenness (SJC28) Score at Week 24 and Week 48

Twenty-eight joints are assessed for swollenness (a score of 1 for a joint denotes a presence of swollenness). The sum is derived to create a total score (ranging from 0 to 28; where the highest score indicate all 28 joints are swollen). Mean changes from baseline were derived from an analysis of covariance (ANCOVA) model with treatment as factor and baseline SJC28 Score and geographic region as covariates. A negative change denotes an improvement.

Change From Baseline in 28 Joint Count Tenderness (TJC28) Score at Week 24 and Week 48

Twenty-eight joints are assessed for tenderness (a score of 1 for a joint denotes a presence of tenderness). The sum is derived to create a total score (ranging from 0 to 28; where the highest score indicate all 28 joints are tender). Mean changes from baseline were derived from an analysis of covariance (ANCOVA) model with treatment as factor and baseline TJC28 Score and geographic region as covariates. A negative change denotes and improvement.

Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Activity Score at Week 12, Week 24 and Week 48

CLASI Activity is scored based on erythema, scale/hyperkeratosis, mucous membrane involvement, acute hair loss and nonscarring alopecia. Evaluation of erythema and scale/hyperkeratosis is based on a table: rows represent anatomical areas and columns represent major clinical symptoms. The extent of involvement for each of the skin symptoms is documented for each anatomic area (erythema: 0=absent, 1=pink, 2=red, 3=dark red; scale: 0=absent, 1=scale, 2=verrucous/hypertrophic). Mucous membrane involvement and acute hair loss are scored based on the presence (=1) or absence (=0). Nonscarring alopecia is scored as 0=absent, 1=diffuse/non-inflammatory, 2=focal or patchy in 1 quadrant, 3=focal or patchy in >1 quadrant. The total score ranges from 0-70, with higher scores indicating more severe skin disease. Mean changes from baseline were derived from an ANCOVA model with treatment as factor and baseline CLASI Activity Score and geographic region as covariates. Negative change = improvement

Change From Baseline in CLASI Damage Score at Week 12, Week 24 and Week 48

CLASI Damage is scored based on dyspigmentation and scarring. Evaluation of dyspigmentation and scarring is based on a table: rows represent anatomical areas and columns represent major clinical symptoms. The extent of involvement for each of the skin symptoms is documented for each anatomic area (dyspigmentation: 0=absent, 1=present; scarring: 0=absent, 1=scarring, 2=severely atrophic scarring or panniculitis). Subjects are also asked whether dyspigmentation due to SLE lesions usually remains visible for >12 months, which is considered permanent and results in doubling of the dyspigmentation score. Scarring alopecia is scored as follows: 0=absent, 3=1 quadrant, 4=2 quadrants, 5=3 quadrants, 6=affects the whole skull. Total score ranges from 0-56, with higher scores indicating more damaged skin. Mean changes from baseline were derived from an ANCOVA model with treatment as factor and baseline CLASI Damage Score and geographic region as covariates. Negative change = improvement.

ALX-0061 Serum Concentrations at Week 24 and Week 48

Actual Values of Soluble Interleukin 6 Receptor (sIL-6R) Concentrations at Baseline, Week 24, and Week 48

Actual Values of C-reactive Protein (CRP) Concentrations at Baseline, Week 24, and Week 48

Actual Values of Fibrinogen Concentrations at Baseline, Week 24, and Week 48

Actual Values of Anti-double-stranded (ds) DNA Concentrations at Baseline, Week 24, and Week 48

Actual Values of Complement C3 Concentrations at Baseline, Week 24, and Week 48

Actual Values of Complement C4 Concentrations at Baseline, Week 24, and Week 48

Actual Values for Hemolytic Complement Component 50 (CH50) at Baseline, Week 24, and Week 48

Number and Percentage of Subjects Who Were Treatment-emergent (TE) Anti-drug Antibody (ADA) Positive

Full Information

NCT ID

NCT02437890

First Posted

April 29, 2015

Last Updated

February 12, 2019

Sponsor

Ablynx, a Sanofi company

1. Study Identification

Unique Protocol Identification Number

NCT02437890

Brief Title

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

Official Title

A Phase II Multicenter, Randomized, Double-blind, Placebo Controlled, Dose-range Finding Study to Evaluate the Safety and Efficacy of ALX-0061 Administered Subcutaneously in Subjects With Moderate to Severe Active Systemic Lupus Erythematosus

Study Type

Interventional

2. Study Status

Record Verification Date

February 2019

Overall Recruitment Status

Completed

Study Start Date

July 2015 (undefined)

Primary Completion Date

January 2018 (Actual)

Study Completion Date

January 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ablynx, a Sanofi company

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lupus Erythematosus, Systemic

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

312 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Arm Title

ALX-0061 75 mg q4w

Arm Type

Experimental

Arm Description

Arm Title

ALX-0061 150 mg q4w

Arm Type

Experimental

Arm Description

Arm Title

ALX-0061 150 mg q2w

Arm Type

Experimental

Arm Description

Arm Title

ALX-0061 225 mg q2w

Arm Type

Experimental

Arm Description

Intervention Type

Biological

Intervention Name(s)

ALX-0061

Intervention Type

Biological

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

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

Description

Time Frame

At Week 24 visit

Secondary Outcome Measure Information:

Title

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

Description

Number and percentage of mBICLA responders at Week 24 and Week 48

Time Frame

At Week 24 and Week 48

Title

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

Description

Time Frame

At Week 24 and Week 48

Title

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

Description

Time Frame

At Week 24 and Week 48

Title

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

Description

Time Frame

At Week 24 and Week 48

Title

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

Description

Time Frame

At Week 24 and Week 48

Title

Number and Percentage of Subjects With mSRI-8 Response at Week 24 and Week 48.

Description

Time Frame

At Week 24 and Week 48

Title

Change From Baseline in Modified Systemic Lupus Erythematosus Disease Activity Index 2000 (mSLEDAI-2K) Score at Week 24 and Week 48

Description

Time Frame

At Week 24 and Week 48

Title

Number and Percentage of Subjects With BILAG-2004 Normal Improvement at Week 24 and Week 48

Description

Time Frame

At Week 24 and Week 48

Title

Number and Percentage of Subjects With BILAG-2004 Enhanced Improvement at Week 24 and Week 48

Description

Time Frame

At Week 24 and Week 48

Title

BILAG-2004 Total Score at Baseline, Week 24 and Week 48

Description

Time Frame

At Baseline, Week 24 and Week 48

Title

Number and Percentage of Subjects With BILAG-2004 Normal Improvement in Mucocutaneous System at Week 24 and Week 48

Description

Time Frame

At Week 24 and Week 48

Title

Number and Percentage of Subjects With BILAG-2004 Normal Improvement in Musculoskeletal System at Week 24 and Week 48

Description

Time Frame

At Week 24 and Week 48

Title

Number and Percentage of Subjects With Persistent Minimal or no Activity in 9 Organ Systems According to BILAG-2004 Systems Tally at Week 24 and Week 48

Time Frame

At Week 24 and Week 48

Title

Change From Baseline in Physician's Global Assessment (PGA) at Week 24 and Week 48

Description

Time Frame

At Week 24 and Week 48

Title

Change From Baseline in Patient's Global Assessment at Week 24 and Week 48

Description

Time Frame

At Week 24 and Week 48

Title

Change From Baseline in Proteinuria at Week 24 and Week 48

Description

Mean changes from baseline were derived from an analysis of covariance (ANCOVA) model with treatment as factor and baseline proteinuria and geographic region as covariates

Time Frame

At Week 24 and Week 48

Title

Number of Subjects Who Were Treatment-emergent Urine Sediment Positive at Week 24 and Week 48

Description

Efficacy Laboratory Parameters (Urinalysis) - Active Urine Sediment Number of subjects who were urine sediment negative at Baseline, but positive at Week 24 and Week 48, respectively.

Time Frame

At Week 24 and Week 48

Title

Change From Baseline in Serum Creatinine at Week 24 and Week 48

Description

Mean changes from baseline were derived from an analysis of covariance (ANCOVA) model with treatment as factor and baseline serum creatinine and geographic region as covariates

Time Frame

At Week 24 and Week 48

Title

Change From Baseline in Creatinine Clearance Estimation (eGFR) at Week 24 and Week 48

Description

Mean changes from baseline were derived from an analysis of covariance (ANCOVA) model with treatment as factor and baseline eGFR and geographic region as covariates

Time Frame

At Week 24 and Week 48

Title

Number of and Percentage Treatment Failures From Baseline to Week 24 and Week 48

Description

Defined as non-protocol allowed increase in steroid dose, start i.v. or i.m. steroids, or start or increase of immunosuppressant

Time Frame

From Baseline to Week 24 and Week 48

Title

Number and Percentage of Subjects Experiencing Severe Flares According to BILAG-2004 Flare Index From Baseline to Week 24 and Week 48

Time Frame

From Baseline to Week 24 and Week 48

Title

Number and Percentage of Subjects Experiencing Severe Flares According to mSLEDAI-2K Flare Index (mSFI) From Baseline to Week 24 and Week 48

Time Frame

From Baseline to Week 24 and Week 48

Title

Percent Change From Baseline in Daily Dose of Steroids at Week 24 and Week 48

Description

Mean changes from baseline were derived from an analysis of covariance (ANCOVA) model with treatment as factor and baseline prednisone equivalent total daily dose and geographic region as covariates

Time Frame

At Week 24 and Week 48

Title

Number and Percentage of Subjects Whose Daily Dose of Steroids Was Reduced Without Severe Flares During Weeks 40-48

Description

Time Frame

Between Week 40 and Week 48

Title

Number and Percentage of Subjects Who Discontinued Prednisone (or Equivalent) by Week 48 Without Experiencing a Severe Flare

Description

Number and percentage of subjects who discontinued Prednisone (or equivalent) by Week 48 without experiencing a BILAG-2004-defined or mSFI-defined severe flare

Time Frame

Up to and including Week 48

Title

Change From Baseline in Physical Component Scores of Short Form (36) Health Survey (SF-36) at Week 24 and Week 48

Description

Time Frame

At Week 24 and Week 48

Title

Change From Baseline in Mental Component Scores of SF-36 at Week 24 and Week 48

Description

Time Frame

At Week 24 and Week 48

Title

Change From Baseline in 28 Joint Count Swollenness (SJC28) Score at Week 24 and Week 48

Description

Time Frame

At Week 24 and Week 48

Title

Change From Baseline in 28 Joint Count Tenderness (TJC28) Score at Week 24 and Week 48

Description

Time Frame

At Week 24 and Week 48

Title

Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Activity Score at Week 12, Week 24 and Week 48

Description

Time Frame

At Week 12, Week 24 and Week 48

Title

Change From Baseline in CLASI Damage Score at Week 12, Week 24 and Week 48

Description

Time Frame

At Week 12, Week 24 and Week 48

Title

ALX-0061 Serum Concentrations at Week 24 and Week 48

Time Frame

At Week 24 and Week 48

Title

Actual Values of Soluble Interleukin 6 Receptor (sIL-6R) Concentrations at Baseline, Week 24, and Week 48

Time Frame

At Baseline, Week 24, and Week 48

Title

Actual Values of C-reactive Protein (CRP) Concentrations at Baseline, Week 24, and Week 48

Time Frame

At Baseline, Week 24, and Week 48

Title

Actual Values of Fibrinogen Concentrations at Baseline, Week 24, and Week 48

Time Frame

At Baseline, Week 24, and Week 48

Title

Actual Values of Anti-double-stranded (ds) DNA Concentrations at Baseline, Week 24, and Week 48

Time Frame

at Baseline, Week 24, and Week 48

Title

Actual Values of Complement C3 Concentrations at Baseline, Week 24, and Week 48

Time Frame

At Baseline, Week 24, and Week 48

Title

Actual Values of Complement C4 Concentrations at Baseline, Week 24, and Week 48

Time Frame

At Baseline, Week 24, and Week 48

Title

Actual Values for Hemolytic Complement Component 50 (CH50) at Baseline, Week 24, and Week 48

Time Frame

At Baseline, Week 24, and Week 48

Title

Number and Percentage of Subjects Who Were Treatment-emergent (TE) Anti-drug Antibody (ADA) Positive

Time Frame

From first administration of ALX-0061 up to and including follow-up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

64 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Lead

Organizational Affiliation

Ablynx NV

Official's Role

Study Director

Facility Information:

Facility Name

Investigator Site

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35294

Country

United States

Facility Name

Investigator Site

City

Glendale

State/Province

Arizona

ZIP/Postal Code

85306

Country

United States

Facility Name

Investigator Site

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85032

Country

United States

Facility Name

Investigator Site

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85724

Country

United States

Facility Name

Investigator Site

City

Artesia

State/Province

California

ZIP/Postal Code

90701

Country

United States

Facility Name

Investigator Site

City

La Jolla

State/Province

California

ZIP/Postal Code

92093

Country

United States

Facility Name

Investigator Site

City

La Palma

State/Province

California

ZIP/Postal Code

90623

Country

United States

Facility Name

Investigator Site

City

Los Angeles

State/Province

California

ZIP/Postal Code

90057

Country

United States

Facility Name

Investigator Site

City

Upland

State/Province

California

ZIP/Postal Code

91786

Country

United States

Facility Name

Investigator Site

City

Aventura

State/Province

Florida

ZIP/Postal Code

33180

Country

United States

Facility Name

Investigator Site

City

Clearwater

State/Province

Florida

ZIP/Postal Code

33765

Country

United States

Facility Name

Investigator Site

City

Orlando

State/Province

Florida

ZIP/Postal Code

32806

Country

United States

Facility Name

Investigator Site

City

Pinellas Park

State/Province

Florida

ZIP/Postal Code

33781

Country

United States

Facility Name

Investigator Site

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30342

Country

United States

Facility Name

Investigator Site

City

Stockbridge

State/Province

Georgia

ZIP/Postal Code

30281

Country

United States

Facility Name

Investigator Site

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40217

Country

United States

Facility Name

Investigator Site

City

Cumberland

State/Province

Maryland

ZIP/Postal Code

21502

Country

United States

Facility Name

Investigator Site

City

Lansing

State/Province

Michigan

ZIP/Postal Code

48910

Country

United States

Facility Name

Investigator Site

City

New York

State/Province

New York

ZIP/Postal Code

10016

Country

United States

Facility Name

Investigator Site

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

Facility Name

Investigator Site

City

Smithtown

State/Province

New York

ZIP/Postal Code

11787

Country

United States

Facility Name

Investigator Site

City

Syracuse

State/Province

New York

ZIP/Postal Code

13210

Country

United States

Facility Name

Investigator Site

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28210

Country

United States

Facility Name

Investigator Site

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27617

Country

United States

Facility Name

Investigator Site

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15213

Country

United States

Facility Name

Investigator Site

City

Jackson

State/Province

Tennessee

ZIP/Postal Code

38305

Country

United States

Facility Name

Investigator Site

City

Austin

State/Province

Texas

ZIP/Postal Code

78745

Country

United States

Facility Name

Investigator Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77034

Country

United States

Facility Name

Investigator Site

City

Caba

State/Province

Buenos Aires

ZIP/Postal Code

1431

Country

Argentina

Facility Name

Investigator Site

City

Caba

Country

Argentina

Facility Name

Investigator Site

City

Ciudad Autónoma de Buenos Aire

Country

Argentina

Facility Name

Investigator Site

City

Córdoba

Country

Argentina

Facility Name

Investigator Site

City

San Juan

ZIP/Postal Code

5400

Country

Argentina

Facility Name

Investigator Site

City

Tucuman

Country

Argentina

Facility Name

Investigator Site 1

City

Santiago

Country

Chile

Facility Name

Investigator Site 2

City

Santiago

Country

Chile

Facility Name

Investigator Site

City

Prague

Country

Czechia

Facility Name

Investigator Site

City

Berlin

Country

Germany

Facility Name

Investigator Site

City

Dresden

Country

Germany

Facility Name

Investigator Site

City

Mainz

Country

Germany

Facility Name

Investigator Site

City

Mannheim

Country

Germany

Facility Name

Investigator Site 1

City

Budapest

Country

Hungary

Facility Name

Investigator Site 2

City

Budapest

Country

Hungary

Facility Name

Investigator Site

City

Debrecen

Country

Hungary

Facility Name

Investigator Site

City

Gyula

Country

Hungary

Facility Name

Investigator Site

City

Zalaegerszeg

Country

Hungary

Facility Name

Investigator Site

City

Daegu

Country

Korea, Republic of

Facility Name

Investigator Site

City

Gwangju

Country

Korea, Republic of

Facility Name

Investigator Site 1

City

Seoul

Country

Korea, Republic of

Facility Name

Investigator Site 2

City

Seoul

Country

Korea, Republic of

Facility Name

Investigator Site 1

City

Guadalajara

Country

Mexico

Facility Name

Investigator Site 2

City

Guadalajara

Country

Mexico

Facility Name

Investigator Site 3

City

Guadalajara

Country

Mexico

Facility Name

Investigator Site

City

Merida

Country

Mexico

Facility Name

Investigator Site

City

Mexicali

Country

Mexico

Facility Name

Investigator Site

City

Mexico City

Country

Mexico

Facility Name

Investigator Site

City

San Luis Potosi

Country

Mexico

Facility Name

Investigator Site 1

City

Lima

Country

Peru

Facility Name

Investigator Site 2

City

Lima

Country

Peru

Facility Name

Investigator Site 3

City

Lima

Country

Peru

Facility Name

Investigator Site 4

City

Lima

Country

Peru

Facility Name

Investigator Site 1

City

Cebu City

Country

Philippines

Facility Name

Investigator Site 2

City

Cebu City

Country

Philippines

Facility Name

Investigator Site

City

Lipa City

Country

Philippines

Facility Name

Investigator Site

City

Makati City

Country

Philippines

Facility Name

Investigator Site

City

Manila

Country

Philippines

Facility Name

Investigator Site

City

Quezon City

Country

Philippines

Facility Name

Investigator Site

City

Bydgoszcz

Country

Poland

Facility Name

Investigator Site

City

Katowice

Country

Poland

Facility Name

Investigator Site 1

City

Poznan

Country

Poland

Facility Name

Investigator Site 2

City

Poznan

Country

Poland

Facility Name

Investigator Site

City

Szczecin

Country

Poland

Facility Name

Investigator Site 1

City

Łódź

Country

Poland

Facility Name

Investigator Site 2

City

Łódź

Country

Poland

Facility Name

Investigator Site

City

Almada

Country

Portugal

Facility Name

Investigator Site

City

Amadora

Country

Portugal

Facility Name

Investigator Site

City

Lisboa

Country

Portugal

Facility Name

Investigator Site

City

Ponte de Lima

Country

Portugal

Facility Name

Investigator Site

City

Porto

Country

Portugal

Facility Name

Investigator Site

City

Kazan

Country

Russian Federation

Facility Name

Investigator Site

City

Kemerovo

Country

Russian Federation

Facility Name

Investigator Site

City

Orenburg

Country

Russian Federation

Facility Name

Investigator Site

City

Ryazan

Country

Russian Federation

Facility Name

Investigator Site 1

City

Saint-Petersburg

Country

Russian Federation

Facility Name

Investigator Site 2

City

Saint-Petersburg

Country

Russian Federation

Facility Name

Investigator Site

City

Smolensk

Country

Russian Federation

Facility Name

Investigator Site

City

Vladimir

Country

Russian Federation

Facility Name

Investigator Site

City

Voronezh

Country

Russian Federation

Facility Name

Investigator Site 1

City

Belgrade

Country

Serbia

Facility Name

Investigator Site 2

City

Belgrade

Country

Serbia

Facility Name

Investigator Site 3

City

Belgrade

Country

Serbia

Facility Name

Investigator Site 4

City

Belgrade

Country

Serbia

Facility Name

Investigator Site 5

City

Belgrade

Country

Serbia

Facility Name

Investigator Site

City

Niska Banja

Country

Serbia

Facility Name

Investigator Site

City

A Coruna

Country

Spain

Facility Name

Investigator Site 1

City

Barcelona

Country

Spain

Facility Name

Investigator Site 2

City

Barcelona

Country

Spain

Facility Name

Investigator Site 3

City

Barcelona

Country

Spain

Facility Name

Investigator Site

City

Bilbao

Country

Spain

Facility Name

Investigator Site 1

City

Madrid

Country

Spain

Facility Name

Investigator Site 2

City

Madrid

Country

Spain

Facility Name

Investigator Site

City

Sant Joan Despi

Country

Spain

Facility Name

Investigator Site

City

Kaohsiung

Country

Taiwan

Facility Name

Investigator Site 1

City

Taichung

Country

Taiwan

Facility Name

Investigator Site 2

City

Taichung

Country

Taiwan

Facility Name

Investigator Site

City

Taipei

Country

Taiwan

Facility Name

Investigator Site

City

Taoyuan

Country

Taiwan

Facility Name

Investigator Site

City

Ivano-Frankivs'k

Country

Ukraine

Facility Name

Investigator Site

City

Kharkiv

Country

Ukraine

Facility Name

Investigator Site

City

Kryvyi Rih

Country

Ukraine

Facility Name

Investigator Site 1

City

Kyiv

Country

Ukraine

Facility Name

Investigator Site 2

City

Kyiv

Country

Ukraine

Facility Name

Investigator Site 3

City

Kyiv

Country

Ukraine

Facility Name

Investigator Site

City

Lviv

Country

Ukraine

Facility Name

Investigator Site 1

City

Poltava

Country

Ukraine

Facility Name

Investigator Site 2

City

Poltava

Country

Ukraine

Facility Name

Investigator Site 1

City

Vinnytsia

Country

Ukraine

Facility Name

Investigator Site 2

City

Vinnytsia

Country

Ukraine

12. IPD Sharing Statement

Citations:

PubMed Identifier

33687069

Citation

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.

Results Reference

derived

Learn more about this trial

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

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

Lupus Erythematosus, Systemic

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial