This is the classic website, which will be retired eventually. Please visit the modernized ClinicalTrials.gov instead.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04129164
Recruitment Status : Completed
First Posted : October 16, 2019
Last Update Posted : April 8, 2024
Sponsor:
Information provided by (Responsible Party):
Amgen

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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).

Condition or disease Intervention/treatment Phase
Sjögren's Syndrome Drug: VIB4920 Drug: Placebo Phase 2

Detailed Description:

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.

Study acquired from Horizon in 2024.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 183 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2 Randomized, Double-blind, Placebo-controlled, Proof of Concept Study to Evaluate the Efficacy and Safety of VIB4920 in Subjects With Sjögren's Syndrome (SS)
Actual Study Start Date : October 16, 2019
Actual Primary Completion Date : September 1, 2022
Actual Study Completion Date : March 10, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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.
 Drug: VIB4920
Intravenous Dose 1.
Other Name: Dazodalibep

Drug: Placebo
Intravenous dose matched to VIB4920.
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.
 Drug: VIB4920
Intravenous Dose 1.
Other Name: Dazodalibep

Drug: Placebo
Intravenous dose matched to VIB4920.
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.
 Drug: VIB4920
Intravenous Dose 1.
Other Name: Dazodalibep

Drug: Placebo
Intravenous dose matched to VIB4920.
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.
 Drug: VIB4920
Intravenous Dose 1.
Other Name: Dazodalibep

Drug: Placebo
Intravenous dose matched to VIB4920.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Change From Baseline in European League Against Rheumatism (EULAR) Sjögren's Syndrome Disease Activity Index (ESSDAI) at Day 169 in Population 1 [ Time Frame: Baseline (Day 1) and Day 169 ]
  2. Change From Baseline in EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) at Day 169 in Population 2 [ Time Frame: Baseline (Day 1) and Day 169 ]

Secondary Outcome Measures :
  1. Change From Baseline in ESSPRI at Day 169 in Population 1 [ Time Frame: Baseline (Day 1) and Day 169 ]
  2. Percentage of Participants achieving ESSDAI [3] and ESSDAI [4] response in Population 1 [ Time Frame: Baseline (Day 1) to Day 169 ]
  3. Percentage of Participants achieving ESSPRI response in Population 2 [ Time Frame: Baseline (Day 1) to Day 169 ]
  4. Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Score at Day 169 in Populations 1 and 2 [ Time Frame: Baseline (Day 1) and Day 169 ]
  5. Change From Baseline in Ocular Surface Disease Index (OSDI) at Day 169 in Populations 1 and 2 [ Time Frame: Baseline (Day 1) and Day 169 ]
  6. Patient's Global Impression of Severity at Day 169 in Populations 1 and 2 [ Time Frame: Day 169 ]
  7. Number of participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) in Populations 1 and 2 [ Time Frame: From Baseline (Day 1) up to Day 365 ]
  8. Number of participants With Adverse Events of Special Interest (AESIs) in Populations 1 and 2 [ Time Frame: From Baseline (Day 1) up to Day 365 ]
  9. Number of Participants With Abnormal Laboratory Parameters, Vital Signs, and Electrocardiograms (ECGs) Reported as TEAEs in Populations 1 and 2 [ Time Frame: From Baseline (Day 1) up to Day 365 ]
  10. Plasma Concentration of VIB4920 [ Time Frame: Day 1 to Day 365 ]
  11. Percentage of Participants With Positive Antibody Titer to VIB4920 in Populations 1 and 2 [ Time Frame: Day 1 to Day 365 ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04129164


Locations
Show Show 63 study locations
Sponsors and Collaborators
Amgen
Investigators
Layout table for investigator information
Study Director: MD Amgen
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT04129164    
Other Study ID Numbers: VIB4920.P2.S2
2019-002713-19 ( EudraCT Number )
First Posted: October 16, 2019    Key Record Dates
Last Update Posted: April 8, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Amgen:
Sjögren's Syndrome
SS
VIB4920
MEDI4920
Additional relevant MeSH terms:
Layout table for MeSH terms
Sjogren's Syndrome
Syndrome
Disease
Pathologic Processes
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
Autoimmune Diseases
Immune System Diseases