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A Study of the Efficacy and Safety of Belimumab in Adults With Interstitial Lung Disease Associated With Connective Tissue Disease

Phase 3
Recruiting
Conditions
Lung Diseases, Interstitial
Interventions
Other: Placebo
Registration Number
NCT06572384
Lead Sponsor
GlaxoSmithKline
Brief Summary

Interstitial lung disease (ILD) is a lung condition resulting in inflammation and stiffening of the lung, often associated with connective tissue diseases (CTDs). ILD causes reduction in lung volume, shortness of breath, cough and fatigue therefore has high impact on quality of life and is also the leading cause of death in participants with these conditions. The study will assess whether treatment of CTD-ILD participants with belimumab in addition to standard therapy will result in the stabilization and/or improvement of lung function and improve symptoms associated with ILD with an acceptable safety profile.

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
440
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
BelimumabBelimumabParticipants will receive belimumab in addition to standard therapy.
PlaceboPlaceboParticipants will receive placebo in addition to standard therapy.
Primary Outcome Measures
NameTimeMethod
Absolute Change from Baseline in Forced Vital Capacity (FVC) milliliter (mL) at Week 52Baseline and Week 52

Forced vital capacity is the total amount of air exhaled during the lung function test. Low FVC (mL) reflects more impaired lung function. Absolute Change from Baseline in FVC will be reported.

Secondary Outcome Measures
NameTimeMethod
Absolute Change from Baseline in FVC Percentage (%) Predicted at Week 52Baseline and Week 52

FVC are expressed as a percentage of the predicted normal for a person of the same sex, age, and height. Lower % predicted FVC (mL) reflects more impaired lung function.

Time to ILD Progression or DeathFrom the date of assignment (Day 1) until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 52 Weeks

Time taken for a participant to experience ILD progression or death.

Number of Participants with Respiratory Related Hospitalizations up to Week 52Up to Week 52
Absolute Change from Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Score at Week 52Baseline and Week 52

The FACIT-Fatigue is a short, 13-item questionnaire that assesses self-reported fatigue and its associated impact for daily activities over the past 7 days. The scale range is from 0 to 52, with 0 being the worst possible score and 52 being the best possible score (indicating less/no fatigue).

Absolute Change from Baseline in Living with Pulmonary Fibrosis (L-PF) Total Symptom Score at Week 52Baseline and Week 52

The L-PF questionnaire is a 49-item questionnaire with two modules: 1) symptoms (28 items) and 2) impacts (21 items). The Symptoms module yields three domain scores: 1) dyspnea, 2) cough and 3) fatigue as well as a total Symptoms score. Participants rate the severity of their symptoms in the last 24 hour on a 5-point rating scale. Scoring is performed as a summary score, the mean of the dimension ratings multiplied by 100. Summary scores range from 0-100, with the higher the score the greater the impairment.

Absolute Change from Baseline in Quantitative Interstitial Lung Disease in the Whole Lung (QILD-WL) At Week 52Baseline and Week 52

Change from baseline in extent of architectural distortion (fibrosis), ground glass opacification, and honeycombing features on High-resolution computed tomography (HRCT) as measured by computer-aided analysis tools. Extent of ILD is calculated by summing pixel counts and expressing this as a percentage of the whole lung. ILD extent can range from 0-100% with higher percentage representing more extensive ILD.

Absolute Change from Baseline in Quantitative Measures of Lung Fibrosis (QLF) in the Whole Lung At Week 52Baseline and Week 52

Change from baseline in extent of reticular patterns with architectural distortion (fibrosis) on HRCT as measured by computer-aided analysis tools. Extent of fibrosis is calculated by summing pixel counts and expressing this as a percentage of the whole lung. Fibrosis extent can range from 0-100% with higher percentage representing more extensive fibrosis.

Achieving Greater than or Equal (≥) 2% Decrease in QILD-WL Score at Week 52Up to Week 52
Achieving Relative Decline from Baseline in FVC (mL) ≥ 5% at Week 52Baseline and Week 52
Achieving Relative Decline from Baseline in FVC (mL) ≥ 10% at Week 52Baseline and Week 52
Absolute Change from Baseline in Steroid Dose (Prednisone Equivalent Dose) at Week 52Baseline and Week 52
Time to Connective Tissue Disease ProgressionUp to 52 Weeks

Time taken for a participant to experience CTD progression.

Absolute Change from Baseline in Transition Dyspnea Index (TDI) at Week 52Baseline and Week 52

TDI assess dyspnea severity at baseline and its change over time. TDI includes 3 components: functional impairment, magnitude of task and magnitude of effort. Each component has 7 grades, ranging from -3 (major deterioration) to +3 (major improvement), which are summed to calculate a score, ranging between - 9 and +9. Lower score indicates more severely the participant is affected by dyspnea.

Absolute Change from Baseline in Short Form Health Survey 36-Item Version 2 (SF36-v2) at Week 52Baseline and Week 52

The SF-36 yields an 8-scale profile of functional health and well-being scores as well as physical and mental component health summary scores. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score (0) the more disability.

Absolute Change from Baseline in Living with Pulmonary Fibrosis (L-PF) Impacts Total Score at Week 52Baseline and Week 52

The L-PF questionnaire is a 49-item questionnaire with two modules: 1) symptoms (28 items) and 2) impacts (21 items). The Symptoms module yields three domain scores: 1) dyspnea, 2) cough and 3) fatigue as well as a total Symptoms score. Participants rate the severity of their symptoms in the last 24 hour on a 5-point rating scale. Scoring is performed as a summary score, the mean of the dimension ratings multiplied by 100. Summary scores range from 0-100, with the higher the score (100) the greater the impairment.

Absolute Change from Baseline in Kings Brief Interstitial Lung Disease Questionnaire (K-BILD) at Week 52Baseline and Week 52

The King's Brief Interstitial Lung Disease (K- ILD) questionnaire consists of 15 items (assessed by the patients on a scale ranging from 1 to 7, where 1 and 7 represent worst and best health status). Items are compiled into 3 domains: breathlessness and activities (range: 0-21), psychological (range: 0-34) , and chest symptoms (range: 0-8). Scores are transformed to a range of 0-100 by using logit values (higher scores indicate better health status). A total score and 3 domain scores are calculated ranging from 0-100 with greater scores (100) denoting better quality of life.

Absolute Change from Baseline in Physician Global Assessment (PhGA) at Week 52Baseline and Week 52

The PhGA is a score which enables the treating physician to rate the participants disease on a scale from 0 to 10, where higher score (10) indicates greater severity.

Absolute Change in Patient Global Impression of Change (PGIC)-ILD at Week 52Baseline and Week 52

The PGIC contains two items, a global question asking participants to rate their overall change in ILD severity since first starting this study using a 7-point verbal rating scale, and a yes/no question asking participants to indicate whether the change is meaningful from their perspective.

Absolute Change from Baseline in Diffusing Capacity of the Lung for Carbon Monoxide (DLco) % Predicted at Week 52Baseline and Week 52
Number of Participants with Adverse Events (AEs), Adverse Events of Special Interest (AESIs) Serious Adverse Events (SAEs)Up to Week 60

Trial Locations

Locations (1)

GSK Investigational Site

🇬🇧

Leicester, United Kingdom

GSK Investigational Site
🇬🇧Leicester, United Kingdom
US GSK Clinical Trials Call Center
Contact
877-379-3718
GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
GSKClinicalSupportHD@gsk.com
Augustine Chung
Principal Investigator
Huawei Dong
Principal Investigator
Jeff Golden
Principal Investigator
Ebrahaim Sadeghi-Najafabadi
Principal Investigator
Faye M Pais
Principal Investigator
Lisette Delgado Sanchez
Principal Investigator
Maria Padilla
Principal Investigator
Eyal Kedar
Principal Investigator
Lake Morrison
Principal Investigator
Rohit Gupta
Principal Investigator
Munish Sharma
Principal Investigator
Jorge Alejandro Brigante
Principal Investigator
Natalia Carolina Mariasch
Principal Investigator
Maria Jose Lopez Meiller
Principal Investigator
Jose Maria Malet Ruiz
Principal Investigator
Mercedes Cecilia Cordoba
Principal Investigator
Carlos Martin Elias Rein
Principal Investigator
Rodolfo Navarrete
Principal Investigator
Hector Raul Sueldo
Principal Investigator
Nadia Raquel Benzaquen
Principal Investigator
Vidya Limaye
Principal Investigator
Maureen Rischmueller
Principal Investigator
Peter R Bremner
Principal Investigator
Antoine Froidure
Principal Investigator
Caroline Dahlqvist
Principal Investigator
Gilmar Alves Zonzin
Principal Investigator
Mauro Waldemar Keiserman
Principal Investigator
Philippe Colares
Principal Investigator
Bruno Guedes Baldi
Principal Investigator
Patrice Gauthier
Principal Investigator
Juan Meng
Principal Investigator
Mengtao Li
Principal Investigator
Wubin Long
Principal Investigator
Yang Li
Principal Investigator
Yunfeng Pan
Principal Investigator
Jin Lin
Principal Investigator
Jing Xue
Principal Investigator
Jing Yang
Principal Investigator
Lingyun Sun
Principal Investigator
Wenfeng Tan
Principal Investigator
Jinying Lin
Principal Investigator
Ting Li
Principal Investigator
Weiguo Wan
Principal Investigator
Jian Wu
Principal Investigator
wei wei
Principal Investigator
Jingyang Li
Principal Investigator
Frédéric Gagnadoux
Principal Investigator
Gaétane Nocturne
Principal Investigator
Eric Hachulla
Principal Investigator
Jean-François Viallard
Principal Investigator
Mathieu Salaun
Principal Investigator
Gregoire Prevot
Principal Investigator
Francesco T. Bonella
Principal Investigator
Gunter Assmann
Principal Investigator
Marc Thomas Schmalzing
Principal Investigator
Georgios Katsikas
Principal Investigator
Vasileios Tzilas
Principal Investigator
Dimitrios Boumpas
Principal Investigator
Dimitrios Bogdanos
Principal Investigator
Gianluca Moroncini
Principal Investigator
Lorenzo Dagna
Principal Investigator
Nicoletta Del Papa
Principal Investigator
Dilia Giuggioli
Principal Investigator
Francesco Ciccia
Principal Investigator
Luca Iaccarino
Principal Investigator
Lorenzo Cavagna
Principal Investigator
Marta Mosca
Principal Investigator
Roberto Giacomelli
Principal Investigator
Maria Antonietta D'Agostino
Principal Investigator
Luca Quartuccio
Principal Investigator
Elisa Tinazzi
Principal Investigator
Hidekata Yasuoka
Principal Investigator
Satoshi Kubo
Principal Investigator
Isamu Okamoto
Principal Investigator
Tomohiro Sugimoto
Principal Investigator
Michihito Kono
Principal Investigator
Kimito Kawahata
Principal Investigator
Tomonori Ishii
Principal Investigator
Kunihiko Umekita
Principal Investigator
Yuji Akiyama
Principal Investigator
Hirokazu Sasaki
Principal Investigator
Masataka Kuwana
Principal Investigator
Toshihiro Nanki
Principal Investigator
Akira Yamasaki
Principal Investigator
Daiki Nakagomi
Principal Investigator
Yong-Hyun Kim
Principal Investigator
Jin Woo Song
Principal Investigator
Man Pyo Chung
Principal Investigator
YONG SUK JO
Principal Investigator
Joo Hun Park
Principal Investigator
Hee-young Yoon
Principal Investigator
César Francisco Pacheco Tena
Principal Investigator
Jorge Rojas-Serrano
Principal Investigator
Sergio Duran-Barragan
Principal Investigator
Aaron Alejandro Barrera Rodriguez
Principal Investigator
Pieter van Paassen
Principal Investigator
Jelle Miedema
Principal Investigator
Renske Vorselaars
Principal Investigator
Edgardo Gonzalez Sevillano
Principal Investigator
Ilsa Moreno
Principal Investigator
Bruno Hammerschlag
Principal Investigator
Lorena Noriega
Principal Investigator
Fernando Marquez
Principal Investigator
Ivan Castellví Barranco
Principal Investigator
Jaume Mestre Torres
Principal Investigator
Alejandro Escudero Contreras
Principal Investigator
Julia Martínez Barrio
Principal Investigator
Sara García Carazo
Principal Investigator
Natalia Mena Vázquez
Principal Investigator
José Antonio Cascante Rodrigo
Principal Investigator
Salvador Garcia Morillo
Principal Investigator
Christopher Huntley
Principal Investigator
Fasihul Khan
Principal Investigator
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