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

NCT04129164 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: VIB4920.P2.S22019-002713-19
• Study Type: interventional
• Target: 183
• Locations: 12 countries
• Sites: 62

Brief Summary

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).

Conditions

Sjögren's Syndrome

Keywords

Sjögren's Syndrome; SS; VIB4920; MEDI4920

Outcome Measures

Primary Outcomes (2)

• Population 1: Change From Baseline in ESSDAI at Day 169

  The ESSDAI is a systemic disease activity index for SS, assessing 12 domains (Constitutional, Salivary Glands, Lungs, Kidneys, Musculoskeletal, Peripheral Nervous System, Central Nervous System, Vascular, Gastrointestinal, Hematological, Ocular, and Extraglandular Manifestations). Each domain is graded for activity (0 = no activity to 3 = high activity) and weighted (1 for Biological to 6 for Muscular) based on its clinical significance, with the final score calculated as the sum of all weighted domain scores. The theoretical range is 0 to 123, with disease activity categorized as low (\<5), moderate (5-13), and high (≥14). A positive change form baseline represents an increase in symptoms.

  Baseline and Day 169

• Population 2: Change From Baseline in ESSPRI at Day 169

  The ESSPRI is a self-assessment tool for evaluating symptoms of dryness, fatigue, and pain (articular and/or muscular) in SS. Participants rate each of the three domains on a 0-10 numerical scale (0 = no; 10 maximal imaginable severity). All domains are equally weighted, and the total score is the mean of the three domain scores. The maximum total score for the ESSPRI assessment is 10. A positive change form baseline represents an increase in symptoms.

  Baseline and Day 169

Secondary Outcomes (8)

• Population 1: Change From Baseline in ESSPRI at Day 169

  Baseline and Day 169

• Population 1: Number of Participants Who Achieved ESSDAI[3] and ESSDAI[4] Response at Day 169

  Day 169

• Change From Baseline in The Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Day 169

  Baseline and Day 169

• Change From Baseline in Ocular Surface Disease Index (OSDI) at Day 169

  Baseline and Day 169

• Patient Global Impression of Severity (PGIS) Score at Day 169

  Baseline and Day 169

Study Arms (4)

VIB4920 Dose 1 in Population 1

EXPERIMENTAL

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

Drug: VIB4920; Drug: Placebo

Placebo in Population 1

PLACEBO COMPARATOR

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

Drug: VIB4920; Drug: Placebo

VIB4920 Dose 1 in Population 2

EXPERIMENTAL

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

Drug: VIB4920; Drug: Placebo

Placebo in Population 2

PLACEBO COMPARATOR

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

Drug: VIB4920; Drug: Placebo

Interventions

VIB4920 DRUG

Intravenous Dose 1.

Also known as: Dazodalibep

Placebo in Population 1; Placebo in Population 2; VIB4920 Dose 1 in Population 1; VIB4920 Dose 1 in Population 2

Placebo DRUG

Intravenous dose matched to VIB4920.

Placebo in Population 1; Placebo in Population 2; VIB4920 Dose 1 in Population 1; VIB4920 Dose 1 in Population 2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Amgen: lead

Study Sites (62)

Research Site

Fullerton, California, 92835, United States

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Upland, California, 91786, United States

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Lawrenceville, Georgia, 30046, United States

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Kansas City, Kansas, 66160, United States

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Baltimore, Maryland, 21224, United States

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Wheaton, Maryland, 20902, United States

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Boston, Massachusetts, 02111, United States

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Charlotte, North Carolina, 28204, United States

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Durham, North Carolina, 27710, United States

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Salisbury, North Carolina, 28144, United States

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Wilmington, North Carolina, 28401, United States

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Duncansville, Pennsylvania, 16635, United States

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Memphis, Tennessee, 38119, United States

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Dallas, Texas, 75231, United States

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Houston, Texas, 77084, United States

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Houston, Texas, 77089, United States

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Ciudad Autonoma de Buenos Aires, Buenos Aires, C1114AAH, Argentina

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Bordeaux, France

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Brest, France

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Grenoble, France

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Paris, France

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Strasbourg, France

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Budapest, 1097, Hungary

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Debrecen, 4032, Hungary

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Gyula, 5700, Hungary

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Secunderabad, Andhra Pradesh, 5000003, India

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Ahmedabad, Gujarat, 380015, India

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Bangalore, Karnataka, 560010, India

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Pune, Maharshtra, 411001, India

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Pune, Maharshtra, 411013, India

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Bhubaneswar, Odisha, 751005, India

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Chennai, Tamil Nadu, 600004, India

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Milan, Lambardia, 20122, Italy

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Rome, Lazio, 00161, Italy

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Brescia, Province Of Brescia, 25123, Italy

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Perugia, Umbria, 06129, Italy

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Pisa, 56126, Italy

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Udine, 33100, Italy

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Saltillo, Coahuila, 25000, Mexico

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Guadalajara, Jalisco, 44650, Mexico

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Guadalajara, Jalisco, 44690, Mexico

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Mexico City, 06700, Mexico

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Lima, San Martin de Porres, 31, Peru

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Lima, 1, Peru

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Lima, 33, Peru

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Elblag, Elblag, 82-300, Poland

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Krakow, 30-363, Poland

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Lublin, 20-412, Poland

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Poznan, 60-693, Poland

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Siedlce, 08-110, Poland

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Szczecin, 71-252, Poland

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Warsaw, 02-637, Poland

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Warsaw, 02-691, Poland

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Wroclaw, 02-637, Poland

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Suwon, Gyeonggi-do, 16499, South Korea

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Incheon, Republic of Korea, 21565, South Korea

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Incheon, Republic of Korea, 22332, South Korea

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Seoul, Republic of Korea, 06591, South Korea

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Kaohsiung City, 81362, Taiwan

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Taichung, 40705, Taiwan

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Newcastle upon Tyne, NE1 4LP, United Kingdom

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Truro, TR13LJ, United Kingdom

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Related Publications (1)

• St Clair EW, Baer AN, Ng WF, Noaiseh G, Baldini C, Tarrant TK, Papas A, Devauchelle-Pensec V, Wang L, Xu W, Pham TH, Sikora K, Rees WA, Alevizos I. CD40 ligand antagonist dazodalibep in Sjogren's disease: a randomized, double-blinded, placebo-controlled, phase 2 trial. Nat Med. 2024 Jun;30(6):1583-1592. doi: 10.1038/s41591-024-03009-3. Epub 2024 Jun 5.

  PMID: 38839899 BACKGROUND

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Sjogren's Syndrome

Condition Hierarchy (Ancestors)

Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

medinfo@amgen.com

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2019
• First Posted: October 16, 2019
• Study Start: December 9, 2019
• Primary Completion: September 1, 2022
• Study Completion: March 10, 2023
• Last Updated: April 30, 2025
• Results First Posted: April 30, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

HU (3); PE (3); FR (5); IN (7); IT (6); KR (4); TW (2); GB (2); US (16); PL (9); AR (1); ME (4)