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Brentuximab Vedotin for Systemic Sclerosis

NCT03222492 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2026-05-05

Study results available
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Summary

There is significant unmet need for effective treatment options for Diffuse Cutaneous Systemic Sclerosis (dcSSc). The present study will be a dose-escalation safety trial of brentuximab vedotin, a drug-antibody conjugate approved for the treatment of lymphoma and targeted to the protein CD30 molecule expressed on activated immune cells There is evidence for CD30 involvement in SSc. This study represents the first step in determining safety and tolerability of brentuximab vedotin in SSc.

Conditions

  • Diffuse Cutaneous Systemic Sclerosis
  • Scleroderma
  • dcSSc

Interventions

BIOLOGICAL

Brentuximab Vedotin

Ascending dose cohorts. All cohorts will receive intravenous administration of study medication every 3 weeks for 21 weeks, for a total of eight doses.

BIOLOGICAL

Placebo

Placebo control for blinding (masking), 0.95% normal saline.

Sponsors & Collaborators

  • Immune Tolerance Network (ITN)

    collaborator NETWORK

  • Seagen Inc.

    collaborator INDUSTRY

  • PPD Development, LP

    collaborator INDUSTRY

  • Rho Federal Systems Division, Inc.

    collaborator INDUSTRY

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Dinesh Khanna, MD, MSc · University of Michigan Health System: Department of Internal Medicine, Division of Rheumatology

  • David Fox, MD · University of Michigan Health System: Department of Internal Medicine, Division of Rheumatology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-20
Primary Completion
2023-04-10
Completion
2023-04-10
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT03222492 on ClinicalTrials.gov