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Systemic Lupus ErythematosusPhase 2NCT01283139

A Study to Evaluate the Efficacy and Safety of Sifalimumab in Adults With Systemic Lupus Erythematosus

A Phase 2 study testing Sifalimumab 200 mg, Sifalimumab 600 mg and Sifalimumab 1,200 mg in people with Systemic Lupus Erythematosus, run by MedImmune LLC at 107 sites in 22 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

To evaluate the efficacy and safety of sifalimumab compared to placebo in subjects with moderately to severely active Systemic Lupus Erythematosus (SLE). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Systemic Lupus Erythematosus
What is being tested?
Sifalimumab 200 mg, Sifalimumab 600 mg and Sifalimumab 1,200 mg
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
834 participants
Where
107 sitesin 22 countries
Study dates
31 Mar 2011to 17 Apr 2014
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Inclusion Criteria: - Fulfills at least 4 of American College of Rheumatology (ACR) criteria for systemic lupus erythematosus (SLE) including a positive antinuclear antibody (ANA) or elevated ds-deoxyribonucleic acid (DNA) or Sm antibody at screening - Disease history of SLE greater than or equal to (>=) 24 weeks at screening - Weight more than (>) 40 kilogram (kg) - Currently receiving stable dose of oral prednisone and/or antimalarials/immunosuppressives - Active moderate to severe SLE disease based on SLE disease activity score (SLEDAI) and British Isles Lupus Assessment Group Index (BILAG) and Physicians Global Assessment - No evidence of cervical malignancy on PAP within 6 months of randomization - Female subjects must be willing to avoid pregnancy - Negative TB test or newly positive TB test due to latent TB for which treatment must be initiated at or before randomization. Exclusion Criteria: - Active severe SLE-driven renal disease or unstable renal disease prior to screening - Active severe or unstable neuropsychiatric SLE - Clinically significant active infection including ongoing and chronic infections - History of human immunodeficiency virus (HIV) - Confirmed Positive tests for Hepatitis B or positive test for hepatitis C - History of severe herpes infection such as herpes encephalitis, ophthalmic herpes, disseminated herpes - Herpes Zoster within 3 months of screening - History of cancer other than basal cancer or cervical cancer treated with apparent success >=1 year prior to randomization - Receipt of a biologic agent within 5 half-lives or prior to loss of pharmacodynamic and/or clinical effect (whichever is longer) prior to screening - Live or attenuated vaccine within 4 weeks prior to screening - Subjects with substance abuse - Subjects with significant hematologic abnormalities.

Trial locations and contacts

107 sites in 22 countries.

107 sites in 22 countries

United States17 sites

  • Research Site

    Baltimore, Maryland

  • Research Site

    Brooklyn, New York

  • Research Site

    Charlotte, North Carolina

  • Research Site

    Dallas, Texas

  • Research Site

    Fort Lauderdale, Florida

  • Research Site

    Idaho Falls, Idaho

  • Research Site

    La Jolla, California

  • Research Site

    Lansing, Michigan

  • Research Site

    Manhasset, New York

  • Research Site

    New York, New York

  • Research Site

    Orlando, Florida

  • Research Site

    Palm Desert, California

  • Research Site

    Raleigh, North Carolina

  • Research Site

    San Leandro, California

  • Research Site

    Seattle, Washington

  • Research Site

    Shreveport, Louisiana

  • Research Site

    Stockbridge, Georgia

Other trials in United States

Germany10 sites

  • Research Site

    Berlin

  • Research Site

    Cologne

  • Research Site

    Dresden

  • Research Site

    Frankfurt

  • Research Site

    Kiel

  • Research Site

    Leipzig

  • Research Site

    Mainz

  • Research Site

    Münster

  • Research Site

    Regensburg

  • Research Site

    Würzburg

Other trials in Germany

Spain9 sites

  • Research Site

    Barcelona

  • Research Site

    Guadalajara

  • Research Site

    La Laguna (Tenerife)

  • Research Site

    Madrid

  • Research Site

    Majadahonda

  • Research Site

    Málaga

  • Research Site

    Mérida

  • Research Site

    Santiago de Compostela

  • Research Site

    Seville

Other trials in Spain

Poland8 sites

  • Research Site

    Bialystok

  • Research Site

    Bydgoszcz

  • Research Site

    Katowice

  • Research Site

    Krakow

  • Research Site

    Lublin

  • Research Site

    Olsztyn

  • Research Site

    Poznan

  • Research Site

    Warsaw

Other trials in Poland

United Kingdom7 sites

  • Research Site

    Brighton

  • Research Site

    Cambridge

  • Research Site

    Cannock

  • Research Site

    Guildford

  • Research Site

    Leeds

  • Research Site

    London

  • Research Site

    Manchester

Other trials in United Kingdom

Argentina6 sites

  • Research Site

    Buenos Aires

  • Research Site

    Ciudad Autonoma de Buenos Aire

  • Research Site

    Ciudad de Buenos Aires

  • Research Site

    La Plata

  • Research Site

    Quilmes

  • Research Site

    San Miguel de Tucumán

Other trials in Argentina

Brazil6 sites

  • Research Site

    Curitiba

  • Research Site

    Goiânia

  • Research Site

    Juiz de Fora

  • Research Site

    Porto Alegre

  • Research Site

    Salvador

  • Research Site

    São Paulo

Other trials in Brazil

Italy6 sites

  • Research Site

    Brescia

  • Research Site

    Florence

  • Research Site

    Milan

  • Research Site

    Padova

  • Research Site

    Pisa

  • Research Site

    Roma

Other trials in Italy

South Africa5 sites

  • Research Site

    Cape Town

  • Research Site

    Durban

  • Research Site

    Johannesburg

  • Research Site

    Pinelands

  • Research Site

    Soweto

Other trials in South Africa

France4 sites

  • Research Site

    Bordeaux

  • Research Site

    Le Kremlin-Bicêtre

  • Research Site

    Paris

  • Research Site

    Strasbourg

Other trials in France

Hungary4 sites

  • Research Site

    Budapest

  • Research Site

    Debrecen

  • Research Site

    Miskolc

  • Research Site

    Zalaegerszeg

Other trials in Hungary

Mexico4 sites

  • Research Site

    Chihuahua City

  • Research Site

    Guadalajara

  • Research Site

    México

  • Research Site

    San Luis Potosí City

Other trials in Mexico

Romania4 sites

  • Research Site

    Brasov

  • Research Site

    Bucharest

  • Research Site

    Cluj-Napoca

  • Research Site

    Tg Mures

Other trials in Romania

Chile3 sites

  • Research Site

    Osorno

  • Research Site

    Santiago

  • Research Site

    Viña del Mar

Other trials in Chile

Philippines3 sites

  • Research Site

    Cebu City

  • Research Site

    Iloilo City

  • Research Site

    Manila

Other trials in Philippines

Bulgaria2 sites

  • Research Site

    Plovdiv

  • Research Site

    Sofia

Other trials in Bulgaria

Canada2 sites

  • Research Site

    Québec, Quebec

  • Research Site

    Sherbrooke, Quebec

Other trials in Canada

India2 sites

  • Research Site

    Bangalore

  • Research Site

    Secunderabad

Other trials in India

Peru2 sites

  • Research Site

    Lima

  • Research Site

    San Borja

Other trials in Peru

Jamaica1 site

  • Research Site

    Kingston

Other trials in Jamaica

Netherlands1 site

  • Research Site

    Amsterdam

Other trials in Netherlands

Thailand1 site

  • Research Site

    Bangkok

Other trials in Thailand

About this study

Official title: A Phase 2b, Dose-ranging Study to Evaluate the Efficacy and Safety of Sifalimumab in Adults With Systemic Lupus Erythematosus

To evaluate the efficacy and safety of sifalimumab compared to placebo in subjects with moderately to severely active Systemic Lupus Erythematosus (SLE).

Read the detailed description

This is a Phase 2b, multinational, multicenter, randomized, double-blind, placebo controlled, parallel group study to evaluate the efficacy and safety of three intravenous (IV) treatment regimens of sifalimumab (200, 600, or 1,200 mg) in adult subjects with chronic moderately-to-severely active SLE with an inadequate response to standard of care (SOC) for SLE.

Being tested
Sifalimumab 200 mg, Sifalimumab 600 mg, Sifalimumab 1,200 mg, Placebo
Keywords
SLE, Systemic Lupus Erythematosus, Sifalimumab, MEDI-545
Medical subject headings
Lupus Erythematosus, Systemic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sifalimumab 200 mgBiological

    Also called MEDI-545

    Sifalimumab 200 mg intravenously every 2 weeks for 4 weeks and then monthly for 44 weeks for a total of 14 doses.

  • Sifalimumab 600 mgBiological

    Also called MEDI-545

    Sifalimumab 600 mg intravenously every 2 weeks for 4 weeks and then monthly for 44 weeks for a total of 14 doses.

  • Sifalimumab 1,200 mgBiological

    Also called MEDI-545

    Sifalimumab 1,200 mg intravenously every 2 weeks for 4 weeks and then monthly for 44 weeks for a total of 14 doses.

  • PlaceboOther

    IV Placebo every 2 weeks for 4 weeks and then monthly for 44 weeks

Study groups in NCT01283139
Study groupRoleWhat they receive
Sifalimumab 200 milligram (mg)ExperimentalSifalimumab 200 milligram (mg) will be administered intravenously every 2 weeks for 4 weeks and then monthly for 44 weeks for a total of 14 doses.
Receives: Biological: Sifalimumab 200 mg
Sifalimumab 600 mgExperimentalSifalimumab 600 mg will be administered intravenously every 2 weeks for 4 weeks and then monthly for 44 weeks for a total of 14 doses.
Receives: Biological: Sifalimumab 600 mg
Sifalimumab 1,200 mgExperimentalSifalimumab 1,200 mg will be administered intravenously every 2 weeks for 4 weeks and then monthly for 44 weeks for a total of 14 doses.
Receives: Biological: Sifalimumab 1,200 mg
PlaceboPlacebo comparatorPlacebo matching to sifalimumab will be administered intravenously at a fixed dose every 2 weeks for 4 weeks and then monthly for 44 weeks for a total of 14 doses.
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants Achieving a Response in Systemic Lupus Erythematosus Responder Index 4 (SRI [4])

    SRI (4) responder is defined as: 1) a reduction in baseline Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) disease activity score of greater than or equal to (>=) 4 points (with increased deoxyribonucleic acid [DNA] binding item of SLEDAI-2K score based on the ANA Multi-Lyte® ANA-II Plus Test System); 2) no worsening in Physician Global Assessment (MDGA) (worsening is defined as an increase of >=0.3 from baseline on a 0-3 visual analogue scale) and 3) no worsening in British Isles Lupus Assessment Group (BILAG-2004) (worsening is defined as at least 1 new 'A' score or 2 new 'B' scores on the BILAG-2004 compared with baseline).

    Measured: Day 365

  2. Percentage of Participants Achieving a Positive Response in SRI (4) in 4-Gene Interferon Test High Participants

    SRI (4) responder is defined as: 1) a reduction in baseline SLEDAI-2K disease activity score of >=4 points (with increased DNA binding item of SLEDAI-2K score based on the ANA Multi-Lyte® ANA-II Plus Test System); 2) no worsening in Physician Global Assessment (MDGA) (worsening is defined as an increase of >=0.3 from baseline on a 0-3 visual analogue scale) and 3) no worsening in BILAG-2004 (worsening is defined as at least 1 new 'A' score or 2 new 'B' scores on the BILAG-2004 compared with baseline).

    Measured: Day 365

Secondary outcomes (7)

  1. Percentage of Participants on Greater Than or Equal to 10 mg/Day Oral Prednisone (or Equivalent) at Baseline Who Were Able to Reduce to Less Than or Equal to (<=) 7.5 mg/Day

    Percentage of participants on >=10 mg/day oral corticosteroids (OCS) at baseline who were able to taper it to <=7.5 mg/day by Day 365 were recorded.

    Measured: Day 365

  2. Percentage of Participants With a Cutaneous Lupus Erythematosus Disease Activity and Severity Index (CLASI) Activity Score Greater Than or Equal to (>=) 10 at Baseline Who Achieved a >= 4-point Reduction

    The CLASI consists of two scores, the first summarizes the activity of the disease while the second is a measure of the damage done by the disease. Activity is scored on the basis of erythema, scale/hyperkeratosis, mucous membrane involvement, acute hair loss and non-scarring alopecia. Damage is scored in terms of dyspigmentation and scarring, including scarring alopecia. The percentage of participants with a CLASI activity score >=10 at baseline who achieved a clinically significant (>=4-point) reduction at Day 365 were reported.

    Measured: Day 365

  3. Percentage of Participants Who Achieved a Greater Than 3-Point Improvement in the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale

    FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (not at all) to 4 (very much). Larger the participant's response to the questions (with the exception of 2 negatively stated), greater was the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score).

    Measured: Day 365

  4. Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (TESAEs)

    An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent defined as events present at baseline that worsened in intensity after administration of investigational product or events absent at baseline that emerged after administration of investigational product, for the period extending until the end of participant participation in the study.

    Measured: Day 1 up to Week 74

  5. Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)

    Laboratory investigations included hematology, serum chemistries and urinalysis parameters. Participants with clinically significant abnormalities in these laboratory investigations recorded as TEAEs were reported.

    Measured: Day 1 up to Week 61

  6. Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs)

    Vital sign assessments included blood pressure, pulse rate, temperature, weight and respiratory rate. Vital signs abnormalities recorded as TEAEs were reported.

    Measured: Day 1 up to Week 61

  7. Number of Participants With Abnormal Electrocardiogram (ECG) Findings Reported as TEAEs

    The 12-lead ECG data were summarized and evaluated. Number of participants with clinically significant abnormal ECG findings as assessed by cardiologist were recorded and reported as TEAEs.

    Measured: Day 1 up to Week 56

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jan 2011 (estimated)
  2. Study start31 Mar 2011
  3. Primary completion14 Nov 2013
  4. Study completion17 Apr 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
834 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01283139
Sponsor's protocol ID
CD-IA-MEDI-545-1067
Other IDs
2010-024069-30
Status last verified
Mar 2018
First submitted
20 Jan 2011
Last updated
19 Apr 2018
Data monitoring committee
Yes

Publications

  • Khamashta M, Merrill JT, Werth VP, Furie R, Kalunian K, Illei GG, Drappa J, Wang L, Greth W; CD1067 study investigators. Sifalimumab, an anti-interferon-alpha monoclonal antibody, in moderate to severe systemic lupus erythematosus: a randomised, double-blind, placebo-controlled study. Ann Rheum Dis. 2016 Nov;75(11):1909-1916. doi: 10.1136/annrheumdis-2015-208562. Epub 2016 Mar 23.

    PubMed 27009916

  • 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.

    PubMed 33687069

  • Brohawn PZ, Streicher K, Higgs BW, Morehouse C, Liu H, Illei G, Ranade K. Type I interferon gene signature test-low and -high patients with systemic lupus erythematosus have distinct gene expression signatures. Lupus. 2019 Nov;28(13):1524-1533. doi: 10.1177/0961203319885447. Epub 2019 Oct 29.

    PubMed 31660791

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sifalimumab 200 mg, Sifalimumab 600 mg and Sifalimumab 1,200 mg in people with Systemic Lupus Erythematosus, run by MedImmune LLC at 107 sites in 22 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 107 sites in United States, Germany, Spain, Poland, United Kingdom and 17 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Jul 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Achieving a Response in Systemic Lupus Erythematosus Responder Index 4 (SRI [4]) (time frame: Day 365). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01283139, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2018.

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