A Study to Evaluate the Efficacy and Safety of VIB4920 in Participants With Sjögren's Syndrome

Study Purpose

The purpose of the study is to evaluate the efficacy, safety, and tolerability of VIB4920 (formerly MEDI4920) in adult participants with Sjögren's Syndrome (SS).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Diagnosed with SS by meeting the 2016 American College of Rheumatology (ACR)/EULAR Classification Criteria.
  • - Residual salivary gland function as defined by whole stimulated salivary flow > 0.1 mL/min (only for Population 2).
  • - Have an ESSDAI score of >= 5 at screening; (not including the peripheral nervous system, central nervous system, and pulmonary domains) (only for Population 1).
  • - Have an ESSPRI score of >= 5 at screening (only for Population 2).
  • - Have an ESSDAI score of < 5 at screening (only for Population 2).
  • - Positive for either anti-Ro autoantibodies or rheumatoid factor, or both at screening.
  • - Male and female participants who agree to follow protocol defined contraceptive methods.
  • - No active or untreated latent tuberculosis (TB).

Exclusion Criteria:

  • - Medical history of confirmed deep venous thrombosis or arterial thromboembolism within 2 years of signing the informed consent form (ICF).
  • - Risk factors for venous thromboembolism or arterial thrombosis, prothrombotic status.
  • - Concomitant polymyositis or dermatomyositis or systemic sclerosis.
  • - Active malignancy or history of malignancy, except in situ carcinoma of the cervix and cutaneous basal cell carcinoma.
  • - Hepatitis B, hepatitis C, or human immunodeficiency virus infection.
  • - More than one episode of herpes zoster and/or an opportunistic infection in the last 12 months.
  • - Active viral, bacterial, or other infections or history of more than 2 infections requiring intravenous antibiotics within 12 months prior to signing the ICF.
  • - Participants with corona virus disease 2019 (COVID-19) infection or who, in the judgment of the investigator, are at unacceptable risk of COVID-19 or its complications.
  • - A documented positive severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) test within 2 weeks prior to randomization.
  • - Received live (attenuated) vaccine within the 4 weeks prior to ICF signature.
  • - Treated with any biologic B-cell-depleting therapy within 12 months or other B-cell targeting therapy < 3 months before randomization.
  • - Injectable corticosteroids (including intraarticular) or treatment with > 10 mg/day dose oral prednisone or equivalent within 6 weeks prior to randomization (only for Population 1).
  • - Treated with systemic corticosteroids for indications other than SS, rheumatoid arthritis (RA), and systemic lupus erythematosus (SLE) for more than a total of 2 weeks within 24 weeks prior to screening visit (only for Population 1).
  • - Received previous treatment with anti-CD40L compounds at any time before screening.
  • - Pregnant or lactating or planning to get pregnant during the duration of the study.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04129164
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Viela Bio
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries France, Korea, Republic of, Poland, United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Sjögren's Syndrome
Additional Details

The study will enrol 2 SS populations: Population 1 will include participants with moderate to high systemic disease activity defined by European League Against Rheumatism (EULAR) Sjögren's Syndrome Disease Activity Index (ESSDAI) >= 5; Population 2 will include participants with moderate to severe subjective symptoms defined by EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) score >= 5 and residual stimulated salivary flow but with mild systemic disease activity defined by ESSDAI score < 5. This study will include 3 periods: screening (4 weeks), treatment period (40 Weeks) and follow-up period (12 weeks). In the treatment period, participants from each of the populations will be randomized at 1:1 ratio to receive intravenous (IV) dose of VIB4920 or placebo (Stage I). After completion of Stage I, participants randomized to VIB4920 in Stage I will receive placebo and participants randomized to placebo in Stage I will receive VIB4920 (Stage II). Participants who had study drug discontinuation will not be eligible for treatment during Stage

  • II. All participants will be followed for at least 12 weeks after their last dose of study drug administration.

Arms & Interventions

Arms

Experimental: VIB4920 Dose 1 in Population 1

Participants in population 1 will receive IV VIB4920 Dose 1 in Stage I and placebo matched to VIB4920 in Stage II.

Placebo Comparator: Placebo in Population 1

Participants in population 1 will receive IV placebo matched to VIB4920 in Stage I and IV VIB4920 Dose 1 in Stage II.

Experimental: VIB4920 Dose 1 in Population 2

Participants in population 2 will receive IV VIB4920 Dose 1 in Stage I and placebo matched to VIB4920 in Stage II.

Placebo Comparator: Placebo in Population 2

Participants in population 2 will receive IV placebo matched to VIB4920 in Stage I and IV VIB4920 Dose 1 in Stage II.

Interventions

Drug: - VIB4920

Intravenous Dose 1.

Drug: - Placebo

Intravenous dose matched to VIB4920.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Research Site, Fullerton, California

Status

Recruiting

Address

Research Site

Fullerton, California, 92835

Research site, Upland, California

Status

Recruiting

Address

Research site

Upland, California, 91786

Research Site, Lawrenceville, Georgia

Status

Recruiting

Address

Research Site

Lawrenceville, Georgia, 30046

Research Site, Kansas City, Kansas

Status

Recruiting

Address

Research Site

Kansas City, Kansas, 66160

Research Site, Baltimore, Maryland

Status

Recruiting

Address

Research Site

Baltimore, Maryland, 21218

Research Site, Wheaton, Maryland

Status

Recruiting

Address

Research Site

Wheaton, Maryland, 20902

Research Site, Boston, Massachusetts

Status

Recruiting

Address

Research Site

Boston, Massachusetts, 02111

Research site, Lansing, Michigan

Status

Withdrawn

Address

Research site

Lansing, Michigan, 48911

Research Site, Charlotte, North Carolina

Status

Recruiting

Address

Research Site

Charlotte, North Carolina, 28204

Research Site, Durham, North Carolina

Status

Recruiting

Address

Research Site

Durham, North Carolina, 27710

Research Site, Salisbury, North Carolina

Status

Recruiting

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Research Site

Salisbury, North Carolina, 28144

Research Site, Wilmington, North Carolina

Status

Recruiting

Address

Research Site

Wilmington, North Carolina, 28401

Research site, Duncansville, Pennsylvania

Status

Recruiting

Address

Research site

Duncansville, Pennsylvania, 16635

Research Site, Memphis, Tennessee

Status

Recruiting

Address

Research Site

Memphis, Tennessee, 38119

Research site, Dallas, Texas

Status

Recruiting

Address

Research site

Dallas, Texas, 75231

Research Site, Houston, Texas

Status

Recruiting

Address

Research Site

Houston, Texas, 77084

Research Site, Houston, Texas

Status

Recruiting

Address

Research Site

Houston, Texas, 77089

International Sites

Research Site, Bordeaux, France

Status

Recruiting

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Research Site

Bordeaux, ,

Research Site, Brest, France

Status

Recruiting

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Research Site

Brest, ,

Research Site, Grenoble, France

Status

Recruiting

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Research Site

Grenoble, ,

Research Site, Paris Cedex 13, France

Status

Recruiting

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Research Site

Paris Cedex 13, ,

Research Site, Paris, France

Status

Recruiting

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Research Site

Paris, ,

Research Site, Strasbourg, France

Status

Recruiting

Address

Research Site

Strasbourg, ,

Research Site, Gyeonggi-do, Republic Of Korea, Korea, Republic of

Status

Recruiting

Address

Research Site

Gyeonggi-do, Republic Of Korea, 16499

Research Site, Incheon, Republic Of Korea, Korea, Republic of

Status

Recruiting

Address

Research Site

Incheon, Republic Of Korea, 21565

Research Site, Incheon, Republic Of Korea, Korea, Republic of

Status

Recruiting

Address

Research Site

Incheon, Republic Of Korea, 22332

Research Site, Seoul, Republic Of Korea, Korea, Republic of

Status

Recruiting

Address

Research Site

Seoul, Republic Of Korea, 06591

Research Site, Krakow, Poland

Status

Recruiting

Address

Research Site

Krakow, , 30-363

Research Site, Lublin, Poland

Status

Recruiting

Address

Research Site

Lublin, , 20-412

Research Site, Poznan, Poland

Status

Recruiting

Address

Research Site

Poznan, , 60-693

Research Site, Siedlce, Poland

Status

Recruiting

Address

Research Site

Siedlce, , 08-110

Research Site, Warsaw, Poland

Status

Recruiting

Address

Research Site

Warsaw, ,

Research Site, Warszawa, Poland

Status

Recruiting

Address

Research Site

Warszawa, , 02-691

Research Site, Truro, United Kingdom

Status

Recruiting

Address

Research Site

Truro, , TR13LJ