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

NCT ID: NCT04163991

Last Updated: 2024-12-17

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-09

Study Completion Date

2021-12-28

Brief Summary

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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).

Detailed Description

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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-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.

Study with completed results acquired from Horizon in 2024.

Conditions

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Rheumatoid Arthritis

Keywords

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Rheumatoid Arthritis RA VIB4920 MEDI4920

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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VIB4920 1500 mg 4 Times

Participants receive intravenous (IV) infusion of VIB4920 1500 mg on Days 1, 15, 29, and 57

Group Type EXPERIMENTAL

VIB4920

Intervention Type DRUG

liquid for IV infusion following dilution in normal saline

VIB4920 1500 mg Twice

Participants receive IV infusion of VIB4920 1500 mg on Days 1 and 57, placebo on Days 15 and 29.

Group Type EXPERIMENTAL

VIB4920

Intervention Type DRUG

liquid for IV infusion following dilution in normal saline

Placebo

Intervention Type DRUG

0.9% saline for IV infusion

VIB4920 3000 mg Twice

Participants receive IV infusion of VIB4920 3000 mg on Days 1 and 57, placebo on Days 15 and 29.

Group Type EXPERIMENTAL

VIB4920

Intervention Type DRUG

liquid for IV infusion following dilution in normal saline

Placebo

Intervention Type DRUG

0.9% saline for IV infusion

VIB4920 3000 mg Once

Participants receive IV infusion of VIB4920 3000 mg on Day 1 and placebo on Days 15, 29, and 57.

Group Type EXPERIMENTAL

VIB4920

Intervention Type DRUG

liquid for IV infusion following dilution in normal saline

Placebo

Intervention Type DRUG

0.9% saline for IV infusion

Placebo

Participants receive IV infusion of placebo matched to VIB4920 on Days 1, 15, 29, and 57.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

0.9% saline for IV infusion

Interventions

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VIB4920

liquid for IV infusion following dilution in normal saline

Intervention Type DRUG

Placebo

0.9% saline for IV infusion

Intervention Type DRUG

Other Intervention Names

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MEDI4920 dazodalibep

Eligibility Criteria

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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 (DAS 28) 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 rheumatoid factor (RF) and/or anti-citrullinated protein antibodies (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.

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-cluster of differentiation 40 ligand (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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Amgen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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MD

Role: STUDY_DIRECTOR

Amgen

Locations

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Research Site

Anniston, Alabama, United States

Site Status

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Sun City, Arizona, United States

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Upland, California, United States

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Clearwater, Florida, United States

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Margate, Florida, United States

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Miami Lakes, Florida, United States

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Zephyrhills, Florida, United States

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Atlanta, Georgia, United States

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Lexington, Kentucky, United States

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Wheaton, Maryland, United States

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Charlotte, North Carolina, United States

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Rocky Mount, North Carolina, United States

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Salisbury, North Carolina, United States

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Vandalia, Ohio, United States

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Norman, Oklahoma, United States

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Duncansville, Pennsylvania, United States

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Baytown, Texas, United States

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Dallas, Texas, United States

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Poznan, Greater Poland Voivodeship, Poland

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Krakow, Lesser Poland Voivodeship, Poland

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Nadarzyn, Masovian Voivodeship, Poland

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Siedlce, Masovian Voivodeship, Poland

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Bialystok, Podlaskie Voivodeship, Poland

Site Status

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Elblag, Warmian-Masurian Voivodeship, Poland

Site Status

Research Site

Warsaw, , Poland

Site Status

Countries

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United States Poland

References

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Kivitz A, Wang L, Alevizos I, Gunsior M, Falloon J, Illei G, St Clair EW. The MIDORA trial: a phase II, randomised, double-blind, placebo-controlled, mechanistic insight and dosage optimisation study of the efficacy and safety of dazodalibep in patients with rheumatoid arthritis. RMD Open. 2023 Aug;9(3):e003317. doi: 10.1136/rmdopen-2023-003317.

Reference Type DERIVED
PMID: 37541743 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2019-003697-70

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

VIB4920.P2.S3

Identifier Type: -

Identifier Source: org_study_id