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BLISSc-ILD

  • Status
    Accepting Candidates
  • Age
    18 Years - N/A
  • Sexes
    All
  • Healthy Volunteers
    No
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Objective

This study investigates the efficacy and safety of belimumab compared to placebo, in addition to standard therapy, for the treatment of participants with systemic sclerosis associated interstitial lung disease (SSc-ILD). The study will evaluate the effect of belimumab treatment on lung function as well as on extra-pulmonary disease manifestations, including skin thickening and general symptoms, such as fatigue, that impact quality of life (QoL).

Details

Full study title A Phase 2/3, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Belimumab Administered Subcutaneously in Adults with Systemic Sclerosis Associated Interstitial Lung Disease (SSc-ILD)
Protocol number OCR44216
ClinicalTrials.gov ID NCT05878717
Phase Phase 2/Phase 3

Eligibility

Inclusion Criteria:

  1. Participant is 18 years of age inclusive, or older at the time of signing the informed consent.

  2. Documented diagnosis of SSc as defined by the American College of Rheumatology / European League Against Rheumatism 2013 SSc classification criteria.

  3. Diffuse cutaneous disease, defined as presence of thickened skin with mRSS >0 over at least one skin area proximal to elbows and/or knees in addition to distal areas involvement on Day 1.

  4. Total mRSS �15 on Day 1.

  5. Evidence of interstitial lung disease on centrally read screening HRCT.

  6. Anticentromere antibody negative on central test at screening.

  7. Evidence for active or progressive disease

  8. Participant has an area of uninvolved or mildly thickened skin that, in the opinion of the investigator, would allow SC injection at the abdomen or the front, middle region of the thigh.

  9. Participant is capable and willing to self-administer the study medication or has a caregiver who is capable and willing to administer the study medication throughout the study.

  10. A female participant is eligible to participate if she is not pregnant or

breastfeeding, and one of the following conditions applies:

Is a Woman of Non-Childbearing Potential (WONCBP) OR Is a Woman of Childbearing

Potential (WOCBP) and using a contraceptive method that is highly effective.

  1. Capable of giving signed informed consent.

Exclusion Criteria:

  1. Systemic sclerosis-like illness, including but not limited to localized scleroderma (morphoea), eosinophilic fasciitis, sclerodermoid graft-versus-host disease, fibro mucinous conditions (scleroedema, scleromyxoedema), scleroderma-like conditions that are associated with environmental chemical and drug exposure (e.g., toxic rapeseed oil, vinyl chloride, bleomycin, gadolinium-based contrast agents [nephrogenic systemic fibrosis], or due to metabolic disease).

  2. Primary diagnosis of a rheumatic autoimmune disease other than dcSSc, including but not limited to rheumatoid arthritis, systemic lupus erythematosus, polymyositis, dermatomyositis, systemic vasculitis, Sjogren's syndrome, antisynthetase syndrome, or mixed connective tissue disease, as determined by the investigator.

  3. FVC �45% of predicted, or a DLco (corrected for hemoglobin) �40% of predicted or requiring supplemental oxygen at screening.

  4. Pulmonary arterial hypertension, as determined by the investigator at, or prior to first day of dosing (Day 1).

  5. SSc renal crisis within 6 months prior to the first day of dosing (Day 1. .

  6. History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or interfering with the interpretation of data.

  7. Obstructive pulmonary disease (pre-bronchodilator FEV1/FVC

Lead researcher

  • Ibrahim Faruqi, MD, MPH
    Critical Care Medicine Specialist, Pulmonologist (Lung Specialist)
    Ibrahim Faruqi

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  1. Step
    1

    Contact the research team

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    Primary contact

  2. Step
    2

    Get screened to confirm eligibility

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  3. Step
    3

    Provide your consent to participate

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  4. Step
    4

    Participate

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