Open Label Extension Study of Brentuximab Vedotin in Early dcSSc

NCT05149768 | Recruiting Phase 2 FDA Drug

• 1 other identifier: BV202108
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess safety and efficacy of Brentuximab vedotin, a CD30-directed antibody-drug conjugate, in patients with active diffuse cutaneous systemic sclerosis (dcSSc) who relapsed after discontinuation of Brentuximab vedotin.

Conditions

Diffuse Cutaneous Systemic Sclerosis

Keywords

systemic sclerosis; scleroderma; brentuximab vedotin; CD30-directed antibody-drug conjugate; antirheumatic agents; antineoplastic agents; skin diseases; immunologic factors

Outcome Measures

Primary Outcomes (1)

• Change in skin thickness measured by modified Rodnan Skin Score

  Skin improvement is defined as the mean mRSS decrease of ≥8 points modified Rodnan Skin Score (mRSS): is a standard outcome measure for skin disease in SSc and calculated by measuring skin thickness in 17 different body sites (each site scored 0-3, with a total possible additive score of 51). A higher skin score (or a higher "skin thickness") and progression of this score, is predictive of internal organ involvement and mortality. While a lower or improving (lessening) score is associated with favorable outcomes, including better survival.

  48 weeks

Secondary Outcomes (11)

• Change in skin thickness over time measured by modified Rodnan Skin Score

  12 weeks and 36 weeks

• Change in physician global assessment of disease activity

  12, 24, 36, and 48 weeks.

• Change in physician global assessment of disease severity

  12, 24, 36, and 48 weeks

• Change in physician global assessment of disease damage

  12, 24, 36, and 48 weeks

• Change in patient global assessment of health status

  12, 24, 36, and 48 weeks

Other Outcomes (5)

• Regimen-related toxicities

  assessed for duration of treatment up to 48 weeks, and up to 12 weeks post-treatment

• Infectious complications

  assessed for duration of treatment up to 48 weeks, and up to 1 month post-treatment

• Change in peripheral levels of T-cell activation marker - sIL-2R

  12, 24, 36, and 48 weeks

Study Arms (1)

Administration of Brentuximab vedotin

EXPERIMENTAL

Maximum duration of treatment: 48 weeks Maximum dose allowed: 0.6 mg/kg Route of administration: intravenous

Drug: Brentuximab vedotin

Interventions

Brentuximab vedotin DRUG

Dose 0.6mg/kg will be given every 3 weeks for 16 cycles (48 weeks), in addition to standard of care medications for SSc that may include cyclophosphamide, methotrexate, azathioprine, mycophenolate mofetil (MMF, cellcept) and mycophenolic acid (myfortic)

Also known as: ADCETRIS, SGN-35

Administration of Brentuximab vedotin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with diffuse cutaneous systemic sclerosis enrolled in the Phase II Adcetris study (BV201708) at St. Joseph's Health centre, aged 18 years or older, and:
• Worsening mRSS of ≥ 4 points as compared to mRSS score at the end of treatment visit (week 48) in the initial study (BV201708).
• Able to give informed consent.

You may not qualify if:

• Poor pulmonary function (FVC\<40% and/or DLCO\<30%).
• Pregnancy, breast feeding or child bearing potential without practicing highly effective 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).
• Active tuberculosis (TB) infection.
• Active viral infection with viral replication of hepatitis B or C virus.
• Significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, pancreatic, hematological, 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 \<2.0 x 109/L
• Hemoglobin \<85 g/L

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• Seattle Genetics (now a wholly owned subsidiary of Pfizer): collaborator
• Pfizer: collaborator

Study Sites (1)

Rheumatology Clinic, St. Joseph's Health Care

London, Ontario, N6A 4V2, Canada

RECRUITING

Related Publications (30)

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MeSH Terms

Conditions

Scleroderma, Diffuse; Scleroderma, Systemic; Skin Diseases

Interventions

Brentuximab Vedotin

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins

Study Officials

• Janet E Pope, PhD

  University of Western Ontario, Division of Rheumatology, St. Joseph's Health Care, London, Ontario, Canada

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Janet E Pope, PhD

CONTACT

519-646-6332; Janet.Pope@sjhc.london.on.ca

Amanda Philip

CONTACT

519-646-6000; Amanda.Philip@sjhc.london.on.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Rheumatology

Study Record Dates

• First Submitted: November 24, 2021
• First Posted: December 8, 2021
• Study Start: February 14, 2024
• Primary Completion: February 14, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: November 18, 2024

Record last verified: 2024-11

Locations

CA (1)