A Study to Evaluate the Safety and Efficacy of VIB4920 in Participants With Rheumatoid Arthritis

Study Purpose

The purpose of the study is to evaluate the efficacy, safety, and pharmacokinetics (PK) of VIB4920 (formerly MEDI4920) in adult participants with Rheumatoid Arthritis (RA).

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 - 99 Years
Gender All
More Inclusion & Exclusion Criteria

Principal

Inclusion Criteria:

1. Male or female adults, >= 18 years of age at time of informed consent. 2. Diagnosed with RA according to the European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) 2010 criteria >= 6 months prior to screening. 3. Disease Activity Score in 28 Joints using C-reactive Protein (DAS28-CRP) > 3.2 at screening with >= 4 tender joint count (TJC) and >= 4 swollen joint count (SJC) out of the 28 joints assessed for DAS28 present at screening and confirmed present at visit 2 prior to randomization. 4. Positive for RF and/or ACPA at screening, in accordance with criteria at the central laboratory. 5. Treated with methotrexate (MTX), with or without a concomitant conventional disease-modifying anti-rheumatic drug (cDMARD). 6. Agreeing to use of protocol defined contraception methods. Principal

Exclusion Criteria:

1. Prior or current inflammatory joint disease other than RA. 2. Severe interstitial lung disease. 3. Prior receipt of any biologic B-cell-depleting therapy. 4. Receipt of any anti
  • - tumor necrosis factor alpha (TNF-α) biologic agent < 8 weeks prior to screening.
5. Receipt of any biologic disease-modifying anti-rheumatic drug (bDMARD) with a mechanism of action other than direct TNF- α blockade, < 12 weeks or < 5 half-lives of the drug prior to screening. 6. Injectable corticosteroids or treatment with > 10 mg/day dose of oral prednisolone or equivalent within 4 weeks prior to screening. 7. Previous treatment with anti-CD40L compounds at any time before randomization. 8. Hepatitis B, hepatitis C, or human immunodeficiency virus infection. 9. Pregnant or lactating or planning to get pregnant during the duration of the study. 10. Evidence of active tuberculosis (TB) or being at high risk for TB. 11. History of more than one episode of herpes zoster in the 12 months prior to screening or any opportunistic infection in the 12 months prior to screening, excluding localized mucocutaneous candidiasis. 12. Receipt of live vaccine or live therapeutic infectious agent within the 4 weeks prior to screening.

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.

NCT04163991
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.

Judith Falloon, MD
Principal Investigator Affiliation Viela Bio
Agency Class

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

Industry
Overall Status Recruiting
Countries Poland, United States
Conditions

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

Rheumatoid Arthritis
Additional Details

The overall study period will be approximately 337 days. After a screening period of up to 28 days, the participants will be randomized in a 1:1:1:1:1 ratio to receive intravenous dose of VIB4920 and/or placebo in 5 cohorts. Participants are to be followed on their stable background anti-rheumatoid arthritis (RA) therapy at least through 12 weeks (Day 85), at which time rescue therapy may be instituted. All participants will be followed at least through the primary (interim) analysis (Day 113), and those who have not instituted rescue therapy will be followed through Day 309 to determine the duration of clinical response. The primary analysis will be after all participants have completed Day 113, and the final analysis will be after all participants have completed follow-up.

Arms & Interventions

Arms

Experimental: VIB4920 Dose1 (dosing interval 1)

Participants will receive intravenous (IV) infusion of VIB4920 Dose1 in dosing interval 1.

Experimental: VIB4920 Dose1 (dosing interval 2)+Placebo (dosing interval 3)

Participants will receive IV infusion of VIB4920 Dose1 in dosing interval 2 and placebo matched to VIB4920 in dosing interval 3.

Experimental: VIB4920 Dose2 (dosing interval 2)+Placebo (dosing interval 3)

Participants will receive IV infusion of VIB4920 Dose2 in dosing interval 2 and placebo matched to VIB4920 in dosing interval 3.

Experimental: VIB4920 Dose2 (dosing interval 4)+Placebo (dosing interval 5)

Participants will receive IV infusion of VIB4920 Dose2 in dosing interval 4 and placebo matched to VIB4920 in dosing interval 5.

Placebo Comparator: Placebo (dosing interval 1)

Participants will receive IV infusion of placebo matched to VIB4920 in dosing interval 1.

Interventions

Drug: - VIB4920

VIB4920 Dose 1 or 2 will be administered intravenously per dosing interval of 1 or 2 or 4.

Drug: - Placebo

Placebo will be administered intravenously per dosing interval of 1 or 3 or 5.

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, Anniston, Alabama

Status

Active, not recruiting

Address

Research Site

Anniston, Alabama, 36207

Research Site, Sun City, Arizona

Status

Recruiting

Address

Research Site

Sun City, Arizona, 85704

Research Site, Upland, California

Status

Recruiting

Address

Research Site

Upland, California, 91786

Research Site, Clearwater, Florida

Status

Recruiting

Address

Research Site

Clearwater, Florida, 33765

Research Site, Margate, Florida

Status

Recruiting

Address

Research Site

Margate, Florida, 33063

Research Site, Miami Lakes, Florida

Status

Recruiting

Address

Research Site

Miami Lakes, Florida, 33014

Research Site, Zephyrhills, Florida

Status

Recruiting

Address

Research Site

Zephyrhills, Florida, 33542

Research Site, Atlanta, Georgia

Status

Active, not recruiting

Address

Research Site

Atlanta, Georgia, 30342

Research Site, Lexington, Kentucky

Status

Recruiting

Address

Research Site

Lexington, Kentucky, 40504

Research Site, Wheaton, Maryland

Status

Active, not recruiting

Address

Research Site

Wheaton, Maryland, 20902

Research Site, Charlotte, North Carolina

Status

Recruiting

Address

Research Site

Charlotte, North Carolina, 28210

Research Site, Salisbury, North Carolina

Status

Recruiting

Address

Research Site

Salisbury, North Carolina, 28144

Research Site, Vandalia, Ohio

Status

Recruiting

Address

Research Site

Vandalia, Ohio, 45377

Research Site, Norman, Oklahoma

Status

Active, not recruiting

Address

Research Site

Norman, Oklahoma, 73069

Research Site, Duncansville, Pennsylvania

Status

Recruiting

Address

Research Site

Duncansville, Pennsylvania, 16635

Research Site, Baytown, Texas

Status

Recruiting

Address

Research Site

Baytown, Texas, 77477

Research Site, Dallas, Texas

Status

Active, not recruiting

Address

Research Site

Dallas, Texas, 75231

International Sites

Research Site, Nadarzyn, Mazowieckie, Poland

Status

Recruiting

Address

Research Site

Nadarzyn, Mazowieckie,

Research Site, Siedlce, Mazowieckie, Poland

Status

Active, not recruiting

Address

Research Site

Siedlce, Mazowieckie,

Research Site, Krakow, Małopolskie, Poland

Status

Recruiting

Address

Research Site

Krakow, Małopolskie,

Research Site, Bialystok, Podlaskie, Poland

Status

Recruiting

Address

Research Site

Bialystok, Podlaskie,

Research Site, Elblag, Warmińsko-mazurskie, Poland

Status

Recruiting

Address

Research Site

Elblag, Warmińsko-mazurskie,

Research Site, Poznan, Wielkopolskie, Poland

Status

Active, not recruiting

Address

Research Site

Poznan, Wielkopolskie,

Research Site, Poznan, Wielkopolskie, Poland

Status

Recruiting

Address

Research Site

Poznan, Wielkopolskie,

Research Site, Warszawa, Woj Mazowieckie, Poland

Status

Recruiting

Address

Research Site

Warszawa, Woj Mazowieckie,