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Study to Evaluate BIIB059 (Litifilimab) in Cutaneous Lupus Erythematosus (CLE) With or Without Systemic Lupus Erythematosus (SLE) (LILAC)

Primary Purpose

Systemic Lupus Erythematosus, Active Cutaneous Lupus Erythematosus

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

BIIB059 (litifilimab)

Placebo

About this trial

This is an interventional treatment trial for Systemic Lupus Erythematosus focused on measuring CLE, SLE, Cutaneous Lupus Erythematosus, Systemic Lupus Erythematosus

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

Part A:

Diagnosis of systemic lupus erythematosus (SLE) fulfilling at least 4 out of 11 of the 1997 revised American College of Rheumatology (ACR) classification criteria for SLE along with active skin manifestations and joint involvement.
At least 4 tender joints and at least 4 swollen joints with at least 4 of the swollen joints in the proximal interphalangeal (PIP) joints, metacarpophalangeal (MCP) joints and/or wrist.
Demonstrate at least one sign of active lupus skin disease, including acute cutaneous lupus erythematosus (ACLE), subacute cutaneous lupus erythematosus (SCLE), and/or chronic cutaneous lupus erythematosus (CCLE) (e.g., discoid lupus erythematosus (DLE)), with skin activity defined by SLE Disease Activity Index 2000 (SLEDAI-2K) at the time of Screening and randomization.

Part B:

1. Active skin manifestations Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) ≥8)) and a diagnosis of cutaneous lupus erythematosus (CLE) that has been histologically confirmed (in the past or at Screening), with or without SLE manifestations.

Key Exclusion Criteria:

Active lupus nephritis or moderate-to-severe or chronic kidney disease.
Any active skin conditions other than CLE that may interfere with the study (e.g., psoriasis, non-LE skin lupus, drug-induced lupus).
History of chronic, recurrent (3 or more of the same type of infection in a 12-month period), or recent serious infection (e.g., pneumonia, septicemia, herpes zoster) as determined by the Investigator and requiring anti-infective treatment within 12 weeks prior to Screening.
Use of immunosuppressive or disease-modifying treatments for SLE or CLE that were initiated less than 12 weeks prior to Randomization.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Sites / Locations

Pinnacle Research Group LLC
Arizona Arthritis & Rheumatology
University of Arkansas for Medical Sciences
TriWest Research Associates, LLC
Tien Q Nguyen MD Inc
MD Med Corp
Universtiy of California, Irvine
The Regents of the University of California
Purushotham Akther & Rosan Kotha, MD Inc.
Dermatology Reserach Associates
University Clinical Trials
Richard Barthel, MD
Robin K. Dore, MD, Inc.
Inland Rheumatology Clinical Trials Inc.
Nazanin Firooz, MD Inc.
Denver Arthritis Clinic
Medical Faculty Associates, Inc.
Howard University Hospital
Washington DC VA Medical Center
Clinical Research of West Florida- Corporate
Lakes Research, LLC
Medical Research Center Of Miami
Omega Research Consultants
Compass Research, LLC
DMI Research, Inc.
Advanced Medical Reserarch, PC
Advanced Clinical Research
Dawes Fretzin Clinical Research Group, LLC
Brigham and Women's Hospital
University of Michigan
Washington University School of Medicine
Davis Group, LTD
Valley Hospital
Institute for Rheumatic & Autoimmune diseases, Overlook Medical Center
Albuquerque Center For Rheumatology
North Shore/Long Island Jewish PRIME
Univeristy of North Carolina at Chapel Hill
Joint and Muscle Research Institute
American Health Research, Inc.
Medication Management, LLC
PMG Research of Wilmington, LLC
Ohio State University Clinical Trials
University of Pennsylvania
University of Pittsburg Medical Center
UPMC Arthritis Center
Medical University of South Carolina
Low Country Rheumatology, PA
University of Tennessee Health Sciences Center
Austin Regional Clinic, P.A.
UT Southwestern Medical Center
Accurate Clinical Research, Inc.
Pioneer Research Solutions, Inc.
Virginia Clinical Research
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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

Part A: BIIB059 450 mg

Part A: Placebo

Part B: BIIB059 50 mg

Part B: BIIB059 150 mg

Part B: BIIB059 450 mg

Part B: Placebo

Arm Description

BIIB059 450 mg administered SC, Q4W with an additional dose at Week 2 for a total of 7 doses (Weeks 0, 2, 4, 8, 12, 16, and 20) in participants with SLE with active skin manifestations and joint involvement.

BIIB059 matching placebo administered SC, Q4W with an additional dose at Week 2 for total of 7 doses (Weeks 0, 2, 4, 8, 12, 16, and 20) in participants with SLE with active skin manifestations and joint involvement.

BIIB059 50 mg administered SC, Q4W with an additional loading dose at Week 2 for a total of 5 doses (Weeks 0, 2, 4, 8, and 12) in participants with active CLE with or without systemic manifestations.

BIIB059 150 mg administered SC, Q4W with an additional loading dose at Week 2 for a total of 5 doses (Weeks 0, 2, 4, 8, and 12) in participants with active CLE with or without systemic manifestations.

BIIB059 450 mg administered, Q4W with an additional loading dose at Week 2 for a total of 5 doses (Weeks 0, 2, 4, 8, and 12) in participants with active CLE with or without systemic manifestations.

BIIB059 matching placebo administered SC, Q4W with an additional loading dose at Week 2 for a total of 5 doses (Weeks 0, 2, 4, 8, and 12) in participants with active CLE with or without systemic manifestations.

Outcomes

Primary Outcome Measures

Part A: Change From Baseline in Active Joint Count (28-joint Assessment) to Week 24

An active joint is defined as a joint with pain and signs of inflammation (e.g., tenderness, swelling or effusion). The 28 Joint Count includes assessment of swelling and tenderness in the shoulders, elbows, wrists, metacarpophalangeal joints, proximal interphalangeal joints and knees. The investigator counts how many of the 28 joints are swollen or tender at the given week.

Part B: Percent Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score to Week 16

The Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) is a clinical tool that quantifies disease activity and damage in cutaneous lupus erythematosus (CLE). The activity scale (CLASI-A) includes measurements of erythema, scale and hypertrophy, and mucous membrane disease. Each part of the body is listed separately, from the scalp to the feet, in addition to sections focusing on mucous membrane involvement and alopecia. Points are given for the presence of erythema, scale, mucous membrane lesions, recent hair loss, and inflammatory alopecia. Composite scores are calculated by summing the individual component scores. CLASI-A scores of 0-9, 10-20, and 21-70 represent disease severity of mild, moderate, and severe, respectively. Higher scores indicate more disease activity.

Secondary Outcome Measures

Part A : Percentage of Participants With Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity- 50 (CLASI-50) Response at Week 24

CLASI-50 Response is defined as a 50% improvement from baseline in CLASI-A score at Week 24. The CLASI is a clinical tool that quantifies disease activity and damage in CLE. The activity scale (CLASI-A) includes measurements of erythema, scale and hypertrophy, and mucous membrane disease. Each part of the body is listed separately, from the scalp to the feet, in addition to sections focusing on mucous membrane involvement and alopecia. Points are given for the presence of erythema, scale, mucous membrane lesions, recent hair loss, and inflammatory alopecia. Composite scores are calculated by summing the individual component scores. CLASI-A scores of 0-9, 10-20, and 21-70 represent disease severity of mild, moderate, and severe, respectively. Higher scores indicate more disease activity.

Part B: Percentage of Participants With Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity- 50 (CLASI-50) Response at Week 12 and 16

CLASI-50 Response is defined as a 50% improvement from baseline in CLASI-A score at Weeks 12 and 16. The CLASI is a clinical tool that quantifies disease activity and damage in CLE. The activity scale (CLASI-A) includes measurements of erythema, scale and hypertrophy, and mucous membrane disease. Each part of the body is listed separately, from the scalp to the feet, in addition to sections focusing on mucous membrane involvement and alopecia. Points are given for the presence of erythema, scale, mucous membrane lesions, recent hair loss, and inflammatory alopecia. Composite scores are calculated by summing the individual component scores. CLASI-A scores of 0-9, 10-20, and 21-70 represent disease severity of mild, moderate, and severe, respectively. Higher scores indicate more disease activity.

Part A: Percent Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 12, 16 and 24

The CLASI is a clinical tool that quantifies disease activity and damage in CLE. The activity scale (CLASI-A) includes measurements of erythema, scale and hypertrophy, and mucous membrane disease. Each part of the body is listed separately, from the scalp to the feet, in addition to sections focusing on mucous membrane involvement and alopecia. Points are given for the presence of erythema, scale, mucous membrane lesions, recent hair loss, and inflammatory alopecia. Composite scores are calculated by summing the individual component scores. CLASI-A scores of 0-9, 10-20, and 21-70 represent disease severity of mild, moderate, and severe, respectively. Higher scores indicate more disease activity.

Part B: Percent Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 12

Part A: Percentage of Participants With a >=4-point Reduction From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 24

Part B: Percentage of Participants With a >=4-point Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 12 and 16

Part A: Percentage of Participants With a >=7-point Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 24

Part B: Percentage of Participants With a >=7-point Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 12 and 16

Part A: Percentage of Participants Achieving a Systemic Lupus Erythematosus (SLE) Responder Index >=4 (SRI-4) at Week 24

An SRI-4 at Week 24 was a categorical response variable (Yes/No) incorporating the following criteria for achievement of responder status (i.e., all criteria must have been met to achieve responder status): A reduction from baseline of ≥4 points in SLEDAI-2K, No new organ system affected, as defined by no new BILAG-2004 Grade A and no more than 1 new BILAG-2004 Grade B, No worsening from baseline in participant's lupus disease activity, defined by a <1-point increase in the PGA (VAS) [on a scale of 0 to 10],No changes to protocol-specified medication rules,as follows (all criteria were required to be met): No initiation or increase of SLE standard of care therapy or other disallowed concomitant therapy; Concomitant corticosteroid dosage at Week 24 to be ≤10 mg/day;Concomitant corticosteroid dosage at Week 24 was no more than at Day 1;No increase in corticosteroid dose between Weeks 17 and 24. The percentage of participants who had responded to each of the 4 criteria was also reported.

Part A: Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Score at Week 24

The SLEDAI-2K is a reliable, valid, simple, 1-page activity index that measures disease activity and records features of active lupus as present or not. It uses a weighted checklist to assign a numeric score based on the presence or absence of 24 symptoms at the time of assessment or during the previous 28 days. Each symptom present is assigned between 1 and up to 8 points based on its usual clinical importance, yielding a total score that ranges from 0 points (no symptoms) to 105 points (presence of all defined symptoms), where higher scores representing increased disease activity.

Part A: Percentage of Participants With no New Organ System Affected at Week 24

No new organ system affected, as defined by no new British Isles Lupus Activity Group (BILAG)-2004 A and no more than one new BILAG-2004 B. The BILAG-2004 index categorizes disease activity in each organ system into five different levels from A to E. Grade A represents very active disease, Grade B represents moderate disease activity, Grade C indicates mild stable disease, and grade D implies no disease activity, but suggests the organ system had previously been affected. Grade E indicates no current or previous disease activity. A score is applied to each grade of each organ system using coding scheme of A=12, B=8, C=1, and D/E=0 and is summarized as a total score ranging 0-108. Higher scores indicate more severe disease activity.

Part A: Change From Baseline in Physician's Global Assessment (PGA) of SLE Visual Analog Scale (VAS) Score at Week 24

The PGA is used to quantify disease activity and is measured using an anchored VAS. The PGA asks the Investigator to assess the participants current disease activity from a score of 0 (none) to 3 (severe), where higher score means severe SLE disease activity.

Part A: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that at any dose: Results in death; in the view of the Investigator, places the participant at immediate risk of death (a life-threatening event); however, this does not include an event that, had it occurred in a more severe form, might have caused death; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect.

Part B: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

Part A: Number of Participants With Clinically Significant Laboratory Assessment Abnormalities

Part B: Number of Participants With Clinically Significant Laboratory Assessment Abnormalities

Part A: Number of Participants With Clinically Significant Vital Sign Abnormalities

Part B: Number of Participants With Clinically Significant Vital Sign Abnormalities

Part A: Number of Participants With Clinically Significant 12-Lead Electrocardiograms (ECGs) Abnormalities

Part B: Number of Participants With Clinically Significant 12-Lead Electrocardiograms (ECGs) Abnormalities

Part A: Number of Participants With Positive BIIB059 Antibodies

Part B: Number of Participants With Positive BIIB059 Antibodies

Part A: Absolute Change From Baseline Over Time in Immunoglobulin Levels

Part B: Absolute Change From Baseline Over Time in Immunoglobulin Levels

Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24

Vaccine-related immunoglobulin (Ig) titers for Pneumococcus (S. pneumoniae) were analyzed, including 23 types of serotypes (sero). AB = Antibody.

Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12

Vaccine-related immunoglobulin (Ig) titers for Pneumococcus (S. pneumoniae) were analyzed, including 23 types of serotypes (sero). AB = Antibody.

Part A: Absolute Change From Baseline in Vaccine Titers - Clostridium Tetani (C. Tetani) and Diphtheria at Week 24

Vaccine-related immunoglobulin titers for tetanus and diphtheria were analyzed using international units per milliliter (IU/mL).

Part B: Absolute Change From Baseline in Vaccine Titers - Clostridium Tetani (C. Tetani) and Diphtheria at Week 12

Vaccine-related immunoglobulin titers for tetanus and diphtheria were analyzed.

Part A: Percent Change From Baseline Over Time in Immunoglobulin Levels

Part B: Percent Change From Baseline Over Time in Immunoglobulin Levels

Part A: Percent Change From Baseline in Vaccine Titers at Week 24

Vaccine-related immunoglobulin (Ig) titers for Pneumococcus (S. pneumoniae) including 23 types of serotypes (sero), tetanus and diphtheria were analyzed. AB = Antibody

Part B: Percent Change From Baseline in Vaccine Titers at Week 12

Vaccine-related immunoglobulin (Ig) titers for Pneumococcus (S. pneumoniae) including 23 types of serotypes (sero), tetanus and diphtheria were analyzed. AB = Antibody.

Part A: Serum Concentration of BIIB059

Part B: Serum Concentration of BIIB059

Full Information

NCT ID

NCT02847598

First Posted

June 6, 2016

Last Updated

April 13, 2023

Sponsor

Biogen

1. Study Identification

Unique Protocol Identification Number

NCT02847598

Brief Title

Study to Evaluate BIIB059 (Litifilimab) in Cutaneous Lupus Erythematosus (CLE) With or Without Systemic Lupus Erythematosus (SLE)

Acronym

LILAC

Official Title

A 2-Part Phase 2 Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of BIIB059 in Subjects With Systemic Lupus Erythematosus and Active Skin Manifestations and in Subjects With Active Cutaneous Lupus Erythematosus With or Without Systemic Manifestations

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Completed

Study Start Date

October 20, 2016 (Actual)

Primary Completion Date

August 28, 2019 (Actual)

Study Completion Date

November 18, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Biogen

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The primary purpose of the study is to evaluate the efficacy of BIIB059 (litifilimab) in reducing disease activity in participants with systemic lupus erythematosus (SLE) with active cutaneous manifestations and joint involvement (Part A), and in participants with active cutaneous lupus erythematosus (CLE) (Subacute cutaneous lupus erythematosus (SCLE) or chronic CLE, including discoid lupus erythematosus (DLE)) with or without systemic manifestations (Part B). The secondary objective is to evaluate additional efficacy parameters of BIIB059 in reducing SLE/CLE disease activity, pharmacokinetic parameters, safety and tolerability of BIIB059 (Parts A and B).

6. Conditions and Keywords

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

Systemic Lupus Erythematosus, Active Cutaneous Lupus Erythematosus

Keywords

CLE, SLE, Cutaneous Lupus Erythematosus, Systemic Lupus Erythematosus

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

264 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Part A: BIIB059 450 mg

Arm Type

Experimental

Arm Description

Arm Title

Part A: Placebo

Arm Type

Placebo Comparator

Arm Description

Arm Title

Part B: BIIB059 50 mg

Arm Type

Experimental

Arm Description

BIIB059 50 mg administered SC, Q4W with an additional loading dose at Week 2 for a total of 5 doses (Weeks 0, 2, 4, 8, and 12) in participants with active CLE with or without systemic manifestations.

Arm Title

Part B: BIIB059 150 mg

Arm Type

Experimental

Arm Description

Arm Title

Part B: BIIB059 450 mg

Arm Type

Experimental

Arm Description

BIIB059 450 mg administered, Q4W with an additional loading dose at Week 2 for a total of 5 doses (Weeks 0, 2, 4, 8, and 12) in participants with active CLE with or without systemic manifestations.

Arm Title

Part B: Placebo

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

BIIB059 (litifilimab)

Other Intervention Name(s)

litifilimab

Intervention Description

Administered as specified in the treatment arm.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Administered as specified in the treatment arm.

Primary Outcome Measure Information:

Title

Part A: Change From Baseline in Active Joint Count (28-joint Assessment) to Week 24

Description

Time Frame

Baseline to Week 24

Title

Part B: Percent Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score to Week 16

Description

Time Frame

Baseline to Week 16

Secondary Outcome Measure Information:

Title

Part A : Percentage of Participants With Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity- 50 (CLASI-50) Response at Week 24

Description

Time Frame

Week 24

Title

Part B: Percentage of Participants With Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity- 50 (CLASI-50) Response at Week 12 and 16

Description

Time Frame

Week 12, Week 16

Title

Part A: Percent Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 12, 16 and 24

Description

Time Frame

Baseline, Week 12, 16 and 24

Title

Part B: Percent Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 12

Description

Time Frame

Baseline, Week 12

Title

Part A: Percentage of Participants With a >=4-point Reduction From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 24

Description

Time Frame

Week 24

Title

Part B: Percentage of Participants With a >=4-point Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 12 and 16

Description

Time Frame

Week 12, Week 16

Title

Part A: Percentage of Participants With a >=7-point Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 24

Description

Time Frame

Week 24

Title

Part B: Percentage of Participants With a >=7-point Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 12 and 16

Description

Time Frame

Week 12, Week 16

Title

Part A: Percentage of Participants Achieving a Systemic Lupus Erythematosus (SLE) Responder Index >=4 (SRI-4) at Week 24

Description

Time Frame

Week 24

Title

Part A: Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Score at Week 24

Description

Time Frame

Baseline to Week 24

Title

Part A: Percentage of Participants With no New Organ System Affected at Week 24

Description

Time Frame

Week 24

Title

Part A: Change From Baseline in Physician's Global Assessment (PGA) of SLE Visual Analog Scale (VAS) Score at Week 24

Description

Time Frame

Baseline to Week 24

Title

Part A: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

Description

Time Frame

Baseline up to Week 36

Title

Part B: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

Description

Time Frame

Baseline up to Week 28

Title

Part A: Number of Participants With Clinically Significant Laboratory Assessment Abnormalities

Time Frame

Baseline up to Week 36

Title

Part B: Number of Participants With Clinically Significant Laboratory Assessment Abnormalities

Time Frame

Baseline up to Week 28

Title

Part A: Number of Participants With Clinically Significant Vital Sign Abnormalities

Time Frame

Baseline up to Week 36

Title

Part B: Number of Participants With Clinically Significant Vital Sign Abnormalities

Time Frame

Baseline up to Week 28

Title

Part A: Number of Participants With Clinically Significant 12-Lead Electrocardiograms (ECGs) Abnormalities

Time Frame

Baseline up to Week 36

Title

Part B: Number of Participants With Clinically Significant 12-Lead Electrocardiograms (ECGs) Abnormalities

Time Frame

Baseline up to Week 28

Title

Part A: Number of Participants With Positive BIIB059 Antibodies

Time Frame

Baseline up to Week 24

Title

Part B: Number of Participants With Positive BIIB059 Antibodies

Time Frame

Baseline up to Week 16

Title

Part A: Absolute Change From Baseline Over Time in Immunoglobulin Levels

Time Frame

Baseline up to Week 24

Title

Part B: Absolute Change From Baseline Over Time in Immunoglobulin Levels

Time Frame

Baseline up to Week 16

Title

Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24

Description

Vaccine-related immunoglobulin (Ig) titers for Pneumococcus (S. pneumoniae) were analyzed, including 23 types of serotypes (sero). AB = Antibody.

Time Frame

Baseline to Week 24

Title

Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12

Description

Vaccine-related immunoglobulin (Ig) titers for Pneumococcus (S. pneumoniae) were analyzed, including 23 types of serotypes (sero). AB = Antibody.

Time Frame

Baseline to Week 12

Title

Part A: Absolute Change From Baseline in Vaccine Titers - Clostridium Tetani (C. Tetani) and Diphtheria at Week 24

Description

Vaccine-related immunoglobulin titers for tetanus and diphtheria were analyzed using international units per milliliter (IU/mL).

Time Frame

Baseline to Week 24

Title

Part B: Absolute Change From Baseline in Vaccine Titers - Clostridium Tetani (C. Tetani) and Diphtheria at Week 12

Description

Vaccine-related immunoglobulin titers for tetanus and diphtheria were analyzed.

Time Frame

Baseline to Week 12

Title

Part A: Percent Change From Baseline Over Time in Immunoglobulin Levels

Time Frame

Baseline up to Week 24

Title

Part B: Percent Change From Baseline Over Time in Immunoglobulin Levels

Time Frame

Baseline up to Week 16

Title

Part A: Percent Change From Baseline in Vaccine Titers at Week 24

Description

Vaccine-related immunoglobulin (Ig) titers for Pneumococcus (S. pneumoniae) including 23 types of serotypes (sero), tetanus and diphtheria were analyzed. AB = Antibody

Time Frame

Baseline to Week 24

Title

Part B: Percent Change From Baseline in Vaccine Titers at Week 12

Description

Vaccine-related immunoglobulin (Ig) titers for Pneumococcus (S. pneumoniae) including 23 types of serotypes (sero), tetanus and diphtheria were analyzed. AB = Antibody.

Time Frame

Baseline to Week 12

Title

Part A: Serum Concentration of BIIB059

Time Frame

Part A: pre-dose on Days 1, 29, 85 and 113 and post-dose on Days 1, 8, 29, 85, 169, 197 and 253

Title

Part B: Serum Concentration of BIIB059

Time Frame

Part B: pre-dose on Days 1, 29, 85 and post-dose on Days 1, 29, 85, 113, 141, 169 and 197

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Key Inclusion Criteria: Part A: Diagnosis of systemic lupus erythematosus (SLE) fulfilling at least 4 out of 11 of the 1997 revised American College of Rheumatology (ACR) classification criteria for SLE along with active skin manifestations and joint involvement. At least 4 tender joints and at least 4 swollen joints with at least 4 of the swollen joints in the proximal interphalangeal (PIP) joints, metacarpophalangeal (MCP) joints and/or wrist. Demonstrate at least one sign of active lupus skin disease, including acute cutaneous lupus erythematosus (ACLE), subacute cutaneous lupus erythematosus (SCLE), and/or chronic cutaneous lupus erythematosus (CCLE) (e.g., discoid lupus erythematosus (DLE)), with skin activity defined by SLE Disease Activity Index 2000 (SLEDAI-2K) at the time of Screening and randomization. Part B: 1. Active skin manifestations Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) ≥8)) and a diagnosis of cutaneous lupus erythematosus (CLE) that has been histologically confirmed (in the past or at Screening), with or without SLE manifestations. Key Exclusion Criteria: Active lupus nephritis or moderate-to-severe or chronic kidney disease. Any active skin conditions other than CLE that may interfere with the study (e.g., psoriasis, non-LE skin lupus, drug-induced lupus). History of chronic, recurrent (3 or more of the same type of infection in a 12-month period), or recent serious infection (e.g., pneumonia, septicemia, herpes zoster) as determined by the Investigator and requiring anti-infective treatment within 12 weeks prior to Screening. Use of immunosuppressive or disease-modifying treatments for SLE or CLE that were initiated less than 12 weeks prior to Randomization. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Director

Organizational Affiliation

Biogen

Official's Role

Study Director

Facility Information:

Facility Name

Pinnacle Research Group LLC

City

Anniston

State/Province

Alabama

ZIP/Postal Code

36207

Country

United States

Facility Name

Arizona Arthritis & Rheumatology

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85037

Country

United States

Facility Name

University of Arkansas for Medical Sciences

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72205

Country

United States

Facility Name

TriWest Research Associates, LLC

City

El Cajon

State/Province

California

ZIP/Postal Code

92020

Country

United States

Facility Name

Tien Q Nguyen MD Inc

City

Fountain Valley

State/Province

California

ZIP/Postal Code

92708

Country

United States

Facility Name

MD Med Corp

City

Hemet

State/Province

California

ZIP/Postal Code

92543

Country

United States

Facility Name

Universtiy of California, Irvine

City

Irvine

State/Province

California

ZIP/Postal Code

92697

Country

United States

Facility Name

The Regents of the University of California

City

La Jolla

State/Province

California

ZIP/Postal Code

92037

Country

United States

Facility Name

Purushotham Akther & Rosan Kotha, MD Inc.

City

La Mesa

State/Province

California

ZIP/Postal Code

92120

Country

United States

Facility Name

Dermatology Reserach Associates

City

Los Angeles

State/Province

California

ZIP/Postal Code

90045

Country

United States

Facility Name

University Clinical Trials

City

San Diego

State/Province

California

ZIP/Postal Code

92123

Country

United States

Facility Name

Richard Barthel, MD

City

Santa Barbara

State/Province

California

ZIP/Postal Code

93108

Country

United States

Facility Name

Robin K. Dore, MD, Inc.

City

Tustin

State/Province

California

ZIP/Postal Code

92780

Country

United States

Facility Name

Inland Rheumatology Clinical Trials Inc.

City

Upland

State/Province

California

ZIP/Postal Code

91786

Country

United States

Facility Name

Nazanin Firooz, MD Inc.

City

West Hills

State/Province

California

ZIP/Postal Code

91307

Country

United States

Facility Name

Denver Arthritis Clinic

City

Denver

State/Province

Colorado

ZIP/Postal Code

80230

Country

United States

Facility Name

Medical Faculty Associates, Inc.

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20037

Country

United States

Facility Name

Howard University Hospital

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20060

Country

United States

Facility Name

Washington DC VA Medical Center

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20422

Country

United States

Facility Name

Clinical Research of West Florida- Corporate

City

Clearwater

State/Province

Florida

ZIP/Postal Code

33765

Country

United States

Facility Name

Lakes Research, LLC

City

Miami Lakes

State/Province

Florida

ZIP/Postal Code

33014

Country

United States

Facility Name

Medical Research Center Of Miami

City

Miami

State/Province

Florida

ZIP/Postal Code

33144

Country

United States

Facility Name

Omega Research Consultants

City

Orlando

State/Province

Florida

ZIP/Postal Code

32804

Country

United States

Facility Name

Compass Research, LLC

City

Orlando

State/Province

Florida

ZIP/Postal Code

32806

Country

United States

Facility Name

DMI Research, Inc.

City

Pinellas Park

State/Province

Florida

ZIP/Postal Code

33710

Country

United States

Facility Name

Advanced Medical Reserarch, PC

City

Sandy Springs

State/Province

Georgia

ZIP/Postal Code

30328

Country

United States

Facility Name

Advanced Clinical Research

City

Boise

State/Province

Idaho

ZIP/Postal Code

83642

Country

United States

Facility Name

Dawes Fretzin Clinical Research Group, LLC

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46256

Country

United States

Facility Name

Brigham and Women's Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

Facility Name

University of Michigan

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

Country

United States

Facility Name

Washington University School of Medicine

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Facility Name

Davis Group, LTD

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89128

Country

United States

Facility Name

Valley Hospital

City

Ridgewood

State/Province

New Jersey

ZIP/Postal Code

07450

Country

United States

Facility Name

Institute for Rheumatic & Autoimmune diseases, Overlook Medical Center

City

Summit

State/Province

New Jersey

ZIP/Postal Code

07901

Country

United States

Facility Name

Albuquerque Center For Rheumatology

City

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87102

Country

United States

Facility Name

North Shore/Long Island Jewish PRIME

City

Great Neck

State/Province

New York

ZIP/Postal Code

11020

Country

United States

Facility Name

Univeristy of North Carolina at Chapel Hill

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27599

Country

United States

Facility Name

Joint and Muscle Research Institute

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28204

Country

United States

Facility Name

American Health Research, Inc.

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28207

Country

United States

Facility Name

Medication Management, LLC

City

Greensboro

State/Province

North Carolina

ZIP/Postal Code

27408

Country

United States

Facility Name

PMG Research of Wilmington, LLC

City

Wilmington

State/Province

North Carolina

ZIP/Postal Code

28401

Country

United States

Facility Name

Ohio State University Clinical Trials

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43215

Country

United States

Facility Name

University of Pennsylvania

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Facility Name

University of Pittsburg Medical Center

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15213

Country

United States

Facility Name

UPMC Arthritis Center

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15213

Country

United States

Facility Name

Medical University of South Carolina

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29425

Country

United States

Facility Name

Low Country Rheumatology, PA

City

North Charleston

State/Province

South Carolina

ZIP/Postal Code

29406

Country

United States

Facility Name

University of Tennessee Health Sciences Center

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

38104

Country

United States

Facility Name

Austin Regional Clinic, P.A.

City

Austin

State/Province

Texas

ZIP/Postal Code

78731

Country

United States

Facility Name

UT Southwestern Medical Center

City

Dallas

State/Province

Texas

ZIP/Postal Code

75390

Country

United States

Facility Name

Accurate Clinical Research, Inc.

City

Houston

State/Province

Texas

ZIP/Postal Code

77034

Country

United States

Facility Name

Pioneer Research Solutions, Inc.

City

Houston

State/Province

Texas

ZIP/Postal Code

77099

Country

United States

Facility Name

Virginia Clinical Research

City

Norfolk

State/Province

Virginia

ZIP/Postal Code

23507

Country

United States

Facility Name

Research Site

City

Quilmes

State/Province

Buenos Aires

ZIP/Postal Code

B1878GEG

Country

Argentina

Facility Name

Research Site

City

Bueno Aires

State/Province

Ciudad Autonoma Bueno Aires

ZIP/Postal Code

C1015ABO

Country

Argentina

Facility Name

Research Site

City

Bueno Aires

State/Province

Ciudad Autonoma Bueno Aires

ZIP/Postal Code

C1046AAQ

Country

Argentina

Facility Name

Research Site

City

San Miguel de Tucuman

State/Province

Tucuman

ZIP/Postal Code

T4000AXL

Country

Argentina

Facility Name

Research Site

City

San Miguel de Tucuman

State/Province

Tucuman

ZIP/Postal Code

T4000BRD

Country

Argentina

Facility Name

Research Site

City

Ciudad Autonoma Buenos Aires

ZIP/Postal Code

C1056ABJ

Country

Argentina

Facility Name

Research Site

City

Ciudad Autonoma Buenos Aires

ZIP/Postal Code

C1221ADC

Country

Argentina

Facility Name

Research Site

City

Ciudad Autonoma Buenos Aires

ZIP/Postal Code

C1425AGC

Country

Argentina

Facility Name

Research Site

City

Ciudad Autonoma Buenos Aires

ZIP/Postal Code

C1425DKG

Country

Argentina

Facility Name

Research Site

City

Ciudad Autonoma Buenos Aires

ZIP/Postal Code

C1431FWO

Country

Argentina

Facility Name

Research Site

City

Cordoba

ZIP/Postal Code

5004

Country

Argentina

Facility Name

Research Site

City

Mendoza

ZIP/Postal Code

5500

Country

Argentina

Facility Name

Research Site

City

San Juan

ZIP/Postal Code

5400

Country

Argentina

Facility Name

Research Site

City

Pleven

ZIP/Postal Code

5800

Country

Bulgaria

Facility Name

Research Site

City

Plovdiv

ZIP/Postal Code

4000

Country

Bulgaria

Facility Name

Research Site

City

Plovdiv

ZIP/Postal Code

4002

Country

Bulgaria

Facility Name

Research Site

City

Ruse

ZIP/Postal Code

7000

Country

Bulgaria

Facility Name

Research Site

City

Ruse

ZIP/Postal Code

7002

Country

Bulgaria

Facility Name

Research Site

City

Shumen

ZIP/Postal Code

9700

Country

Bulgaria

Facility Name

Research Site

City

Sofia

ZIP/Postal Code

1407

Country

Bulgaria

Facility Name

Research Site

City

Sofia

ZIP/Postal Code

1431

Country

Bulgaria

Facility Name

Research Site

City

Sofia

ZIP/Postal Code

1463

Country

Bulgaria

Facility Name

Research Site

City

Sofia

ZIP/Postal Code

1606

Country

Bulgaria

Facility Name

Research Site

City

Barranquilla

ZIP/Postal Code

080020

Country

Colombia

Facility Name

Research Site

City

Barranquilla

ZIP/Postal Code

80020

Country

Colombia

Facility Name

Research Site

City

Bogota

ZIP/Postal Code

110221

Country

Colombia

Facility Name

Research Site

City

Bogota

ZIP/Postal Code

111211

Country

Colombia

Facility Name

Research Site

City

Bucaramanga

ZIP/Postal Code

680003

Country

Colombia

Facility Name

Research Site

City

Medellín

ZIP/Postal Code

050034

Country

Colombia

Facility Name

Research Site

City

Jerusalem

ZIP/Postal Code

9112001

Country

Israel

Facility Name

Research Site

City

Ramat Gan

ZIP/Postal Code

5265601

Country

Israel

Facility Name

Research Site

City

Suwon-Si

State/Province

Gyeonggi-do

ZIP/Postal Code

443-380

Country

Korea, Republic of

Facility Name

Research Site

City

Daejeon

ZIP/Postal Code

35233

Country

Korea, Republic of

Facility Name

Research Site

City

Saltillo

State/Province

Coahuila

ZIP/Postal Code

25000

Country

Mexico

Facility Name

Research Site

City

Mexico

State/Province

Distrito Federal

ZIP/Postal Code

03100

Country

Mexico

Facility Name

Research Site

City

Mexico

State/Province

Distrito Federal

ZIP/Postal Code

06700

Country

Mexico

Facility Name

Research Site

City

Mexico

State/Province

Distrito Federal

ZIP/Postal Code

14080

Country

Mexico

Facility Name

Research Site

City

Guadalajara

State/Province

Jalisco

ZIP/Postal Code

44130

Country

Mexico

Facility Name

Research Site

City

Guadalajara

State/Province

Jalisco

ZIP/Postal Code

44690

Country

Mexico

Facility Name

Research Site

City

Morelia

State/Province

Michoacán

ZIP/Postal Code

58260

Country

Mexico

Facility Name

Research Site

City

Cuernavaca

State/Province

Morelos

ZIP/Postal Code

62290

Country

Mexico

Facility Name

Research Site

City

Monterrey

State/Province

Neuvo Leon

ZIP/Postal Code

64000

Country

Mexico

Facility Name

Research Site

City

San Luis Potosi

State/Province

San Luis Potos

ZIP/Postal Code

78213

Country

Mexico

Facility Name

Research Site

City

San Luis Potosi

State/Province

San Luis Potos

ZIP/Postal Code

78240

Country

Mexico

Facility Name

Research Site

City

Merida

State/Province

Yucatan

ZIP/Postal Code

97070

Country

Mexico

Facility Name

Research Site

City

Durango

ZIP/Postal Code

34270

Country

Mexico

Facility Name

Research Site

City

Angeles City

State/Province

Pampanga

ZIP/Postal Code

2009

Country

Philippines

Facility Name

Research Site

City

Batangas

ZIP/Postal Code

4127

Country

Philippines

Facility Name

Research Site

City

Cebu City

ZIP/Postal Code

6000

Country

Philippines

Facility Name

Research Site

City

Dasmarinas

ZIP/Postal Code

4114

Country

Philippines

Facility Name

Research Site

City

Davao City

ZIP/Postal Code

8000

Country

Philippines

Facility Name

Research Site

City

Iloilo City

ZIP/Postal Code

5000

Country

Philippines

Facility Name

Research Site

City

Iloilo

ZIP/Postal Code

5000

Country

Philippines

Facility Name

Research Site

City

Makati City

ZIP/Postal Code

1229

Country

Philippines

Facility Name

Research Site

City

Manila

ZIP/Postal Code

1000

Country

Philippines

Facility Name

Research Site

City

Manila

ZIP/Postal Code

1008

Country

Philippines

Facility Name

Research Site

City

Quezon City

ZIP/Postal Code

1102

Country

Philippines

Facility Name

Research Site

City

Bydgoszcz

ZIP/Postal Code

85-168

Country

Poland

Facility Name

Research Site

City

Krakow

ZIP/Postal Code

30-033

Country

Poland

Facility Name

Research Site

City

Krakow

ZIP/Postal Code

30-363

Country

Poland

Facility Name

Research Site

City

Lodz

ZIP/Postal Code

90-436

Country

Poland

Facility Name

Research Site

City

Olsztyn

ZIP/Postal Code

10-117

Country

Poland

Facility Name

Research Site

City

Poznan

ZIP/Postal Code

60-529

Country

Poland

Facility Name

Research Site

City

Wroclaw

ZIP/Postal Code

50-368

Country

Poland

Facility Name

Research Site

City

Belgrade

ZIP/Postal Code

11000

Country

Serbia

Facility Name

Research Site

City

Niska Banja

ZIP/Postal Code

18205

Country

Serbia

Facility Name

Research Site

City

Sabac

ZIP/Postal Code

15000

Country

Serbia

Facility Name

Research Site

City

Changhua

ZIP/Postal Code

50004

Country

Taiwan

Facility Name

Research Site

City

Kaohsiung

ZIP/Postal Code

824

Country

Taiwan

Facility Name

Research Site

City

Taipei

ZIP/Postal Code

100

Country

Taiwan

Facility Name

Research Site

City

Taoyuan

ZIP/Postal Code

333

Country

Taiwan

Facility Name

Research Site

City

Pathum Thani

State/Province

Klongluang

ZIP/Postal Code

12120

Country

Thailand

Facility Name

Research Site

City

Chiang Mai

State/Province

Muang

ZIP/Postal Code

50200

Country

Thailand

Facility Name

Research Site

City

Khon Kaen

State/Province

Muang

ZIP/Postal Code

40002

Country

Thailand

Facility Name

Research Site

City

Bangkok

State/Province

Pathumwan

ZIP/Postal Code

10330

Country

Thailand

Facility Name

Research Site

City

Hat Yai

State/Province

Songkhla

ZIP/Postal Code

90110

Country

Thailand

12. IPD Sharing Statement

Citations:

PubMed Identifier

36069871

Citation

Furie RA, van Vollenhoven RF, Kalunian K, Navarra S, Romero-Diaz J, Werth VP, Huang X, Clark G, Carroll H, Meyers A, Musselli C, Barbey C, Franchimont N; LILAC Trial Investigators. Trial of Anti-BDCA2 Antibody Litifilimab for Systemic Lupus Erythematosus. N Engl J Med. 2022 Sep 8;387(10):894-904. doi: 10.1056/NEJMoa2118025.

Results Reference

derived

PubMed Identifier

35939578

Citation

Werth VP, Furie RA, Romero-Diaz J, Navarra S, Kalunian K, van Vollenhoven RF, Nyberg F, Kaffenberger BH, Sheikh SZ, Radunovic G, Huang X, Clark G, Carroll H, Naik H, Gaudreault F, Meyers A, Barbey C, Musselli C, Franchimont N; LILAC Trial Investigators. Trial of Anti-BDCA2 Antibody Litifilimab for Cutaneous Lupus Erythematosus. N Engl J Med. 2022 Jul 28;387(4):321-331. doi: 10.1056/NEJMoa2118024.

Results Reference

derived

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

PubMed Identifier

32335844

Citation

Hartmann S, Biliouris K, Naik H, Rabah D, Stevenson L, Shen C, Nestorov IA, Lesko LJ, Trame MN. A clinical population pharmacokinetic/pharmacodynamic model for BIIB059, a monoclonal antibody for the treatment of systemic and cutaneous lupus erythematosus. J Pharmacokinet Pharmacodyn. 2020 Jun;47(3):255-266. doi: 10.1007/s10928-020-09688-y. Epub 2020 Apr 25.

Results Reference

derived

Learn more about this trial

Study to Evaluate BIIB059 (Litifilimab) in Cutaneous Lupus Erythematosus (CLE) With or Without Systemic Lupus Erythematosus (SLE)

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