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Open Label Extension Study of Brentuximab Vedotin in Early dcSSc

NCT05149768 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2024-11-18

No results posted yet for this study

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

Interventions

DRUG

Brentuximab vedotin

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)

Sponsors & Collaborators

  • Seattle Genetics (now a wholly owned subsidiary of Pfizer)

    collaborator UNKNOWN

  • Pfizer

    collaborator INDUSTRY

  • London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

    lead OTHER

Principal Investigators

  • Janet E Pope, PhD · University of Western Ontario, Division of Rheumatology, St. Joseph's Health Care, London, Ontario, Canada

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-14
Primary Completion
2026-02-14
Completion
2026-07-01
FDA Drug
Yes

Countries

  • Canada

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05149768 on ClinicalTrials.gov