Brentuximab Vedotin in Early Diffuse Cutaneous Systemic Sclerosis

  • STATUS
    Recruiting
  • days left to enroll
    60
  • participants needed
    11
  • sponsor
    Lawson Health Research Institute
Updated on 22 March 2022

Summary

The purpose of this study is to assess feasibility, safety and preliminary efficacy of Brentuximab vedotin (Adcetris), a CD30-directed antibody-drug conjugate, in the treatment of active diffuse cutaneous systemic sclerosis (dcSSc).

Description

Systemic sclerosis (SSc, Scleroderma) is a multisystem autoimmune disease characterized by widespread vascular injury and progressive fibrosis of the skin and internal organs. Internal organ involvement results in increased mortality of SSc patients. There is no effective treatment for the majority of patients with early active diffuse scleroderma (diffuse cutaneous systemic sclerosis; dcSSc). These patients early in their disease may be able to reverse their inflammation and reduce the probability of irreversible fibrosis via significant immune modulation. This is a pilot study that will treat 10 patients with early or active dcSSc who meet inclusion criteria to determine if the benefit of Brentuximab vedotin and safety are favorable in order to consider a randomized controlled trial. This is a Phase II study that is uncontrolled and patients will remain on their background immune suppressive treatment unless if contraindicated for safety or drug interactions. The trial is powered to show a mean change in mRSS of 8 over one year in an uncontrolled, unblinded study. The Health Assessment Questionnaire Disability Index (HAQ), patient and physician global scores, inflammatory markers (ESR, CRP), and combined response index in SSc (CRISS) will all be exploratory outcomes. Other outcomes such as changes in CD30-stained cells on skin biopsies with IHC from baseline to end of the trial will be explored if the study is positive.

Details
Condition Diffuse Cutaneous Systemic Sclerosis
Treatment brentuximab vedotin
Clinical Study IdentifierNCT03198689
SponsorLawson Health Research Institute
Last Modified on22 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

age 18 years or older
able to give informed consent
meet the ACR/EULAR classification criteria for SSc
early dcSSc (disease duration ≤ 5 years from first non-Raynaud's phenomenon symptom) OR active dcSSc as determined by worsening mRSS, presence of tendon friction rubs, and/or elevated inflammatory markers thought to be due to active dcSSc and not related to other issues
mRSS≥ 15
a negative TB skin test at screening, or treatment with INH for 6 months or other standardized LBTI (latent TB infection) treatment in the past

Exclusion Criteria

Poor pulmonary function (FVC<40% and/or DLCO<30%)
Pregnancy, breast feeding or child bearing potential without practicing reliable contraception (and partners for men in the study)
Clinically significant pulmonary hypertension requiring drug therapy
Clinically significant cardiac disease
Chronic or ongoing active infectious disease requiring systemic treatment
Seropositivity for human immunodeficiency virus (HIV) at study entry
Active tuberculosis (TB) infection
Active viral infection with viral replication of hepatitis B or C virus at study entry
Significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, pancreatic, haematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease; and cancer
Peripheral neuropathy at screening Grade 2 or higher
Known or suspected hypersensitivity to components of the treatment
Patients known or suspected of not being able to comply with a study protocol (e.g. due to alcoholism, drug dependency or psychological disorder)
Any of the following laboratory abnormalities at screening
Absolute neutrophils count <2000/mm3
Hemoglobin <85 g/L
Platelet count < 100,000/mm3
AST/SGOT or ALT/SGPT >2.0 UNL
Participation in another clinical trial within six weeks before randomization in this
Use of rituximab within the previous 4 months
study
Immunization with a live/ attenuated vaccine less than 4 weeks prior to the baseline visit
Previous use of brentuximab vedotin
Current or history of progressive multifocal leukoencephalopathy (PML)
Clear my responses

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