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

Sjögren's Syndrome Clinical Trial

— SS  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04129164
• Other study ID #: VIB4920.P2.S2
• Secondary ID: 2019-002713-19
• Status: Completed
• Phase: Phase 2
• Start date: October 16, 2019
• Est. completion date: March 10, 2023

Study information

• Verified date: May 2024
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 183
• Est. completion date: March 10, 2023
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Sjogren's Syndrome
• Sjögren's Syndrome
• Syndrome

Intervention

Drug:
• VIB4920
Intravenous Dose 1.
• Placebo
Intravenous dose matched to VIB4920.

Locations

Country	Name	City	State
Argentina	Research Site	Ciudad Autonoma de Buenos Aires	Buenos Aires
France	Research Site	Bordeaux
France	Research Site	Brest
France	Research Site	Grenoble
France	Research Site	Paris
France	Research Site	Paris Cedex 13
France	Research Site	Strasbourg
Hungary	Research Site	Budapest
Hungary	Research Site	Debrecen
Hungary	Research Site	Gyula
India	Research Site	Ahmedabad	Gujarat
India	Research Site	Bangalore	Karnataka
India	Research Site	Bhubaneswar	Odisha
India	Research Site	Chennai	Tamil Nadu
India	Research Site	Pune	Maharshtra
India	Research Site	Pune	Maharshtra
India	Research Site	Secunderabad	Andhra Pradesh
Italy	Research Site	Brescia	Province Of Brescia
Italy	Research Site	Milano	Lambardia
Italy	Research Site	Perugia	Umbria
Italy	Research Site	Pisa
Italy	Research Site	Rome	Lazio
Italy	Research Site	Udine
Korea, Republic of	Research Site	Incheon	Republic Of Korea
Korea, Republic of	Research Site	Incheon	Republic Of Korea
Korea, Republic of	Research Site	Seoul	Republic Of Korea
Korea, Republic of	Research Site	Suwon si	Gyeonggi
Mexico	Research Site	Ciudad de mexico
Mexico	Research Site	Guadalajara	Jalisco
Mexico	Research Site	Guadalajara	Jalisco
Mexico	Research Site	Saltillo	Coahuila
Peru	Research Site	Lima	San Martin De Porres
Peru	Research Site	Lima
Peru	Research Site	Lima
Poland	Research Site	Elblag	Elblag
Poland	Research Site	Krakow
Poland	Research Site	Lublin
Poland	Research Site	Poznan
Poland	Research Site	Siedlce
Poland	Research Site	Szczecin
Poland	Research Site	Warszawa
Poland	Research Site	Warszawa
Poland	Research Site	Wroclaw
Taiwan	Research Site	Kaohsiung
Taiwan	Research Site	Taichung City
United Kingdom	Research Site	Newcastle Upon Tyne
United Kingdom	Research Site	Truro
United States	Research Site	Baltimore	Maryland
United States	Research Site	Boston	Massachusetts
United States	Research Site	Charlotte	North Carolina
United States	Research site	Dallas	Texas
United States	Research site	Duncansville	Pennsylvania
United States	Research Site	Durham	North Carolina
United States	Research Site	Fullerton	California
United States	Research Site	Houston	Texas
United States	Research Site	Houston	Texas
United States	Research Site	Kansas City	Kansas
United States	Research Site	Lawrenceville	Georgia
United States	Research Site	Memphis	Tennessee
United States	Research Site	Salisbury	North Carolina
United States	Research site	Upland	California
United States	Research Site	Wheaton	Maryland
United States	Research Site	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Countries where clinical trial is conducted

United States,  Argentina,  France,  Hungary,  India,  Italy,  Korea, Republic of,  Mexico,  Peru,  Poland,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in European League Against Rheumatism (EULAR) Sjögren's Syndrome Disease Activity Index (ESSDAI) at Day 169 in Population 1		Baseline (Day 1) and Day 169
Primary	Change From Baseline in EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) at Day 169 in Population 2		Baseline (Day 1) and Day 169
Secondary	Change From Baseline in ESSPRI at Day 169 in Population 1		Baseline (Day 1) and Day 169
Secondary	Percentage of Participants achieving ESSDAI [3] and ESSDAI [4] response in Population 1		Baseline (Day 1) to Day 169
Secondary	Percentage of Participants achieving ESSPRI response in Population 2		Baseline (Day 1) to Day 169
Secondary	Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Score at Day 169 in Populations 1 and 2		Baseline (Day 1) and Day 169
Secondary	Change From Baseline in Ocular Surface Disease Index (OSDI) at Day 169 in Populations 1 and 2		Baseline (Day 1) and Day 169
Secondary	Patient's Global Impression of Severity at Day 169 in Populations 1 and 2		Day 169
Secondary	Number of participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) in Populations 1 and 2		From Baseline (Day 1) up to Day 365
Secondary	Number of participants With Adverse Events of Special Interest (AESIs) in Populations 1 and 2		From Baseline (Day 1) up to Day 365
Secondary	Number of Participants With Abnormal Laboratory Parameters, Vital Signs, and Electrocardiograms (ECGs) Reported as TEAEs in Populations 1 and 2		From Baseline (Day 1) up to Day 365
Secondary	Plasma Concentration of VIB4920		Day 1 to Day 365
Secondary	Percentage of Participants With Positive Antibody Titer to VIB4920 in Populations 1 and 2		Day 1 to Day 365