Clinical Trials Logo
  1. Home
  2. Scleroderma
  3. NCT03222492

Brentuximab Vedotin for Systemic Sclerosis — BRAVOS  

Scleroderma Clinical Trial

Official title:
Evaluation of Brentuximab Vedotin for Diffuse Cutaneous Systemic Sclerosis BRAVOS: A Phase 1/2 Multicenter Randomized, Double Blinded, Safety Study (ITN075AI)

Clinical Trial 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.

Clinical Trial Description

This is a multicenter prospective double blind placebo controlled dose escalation safety clinical trial with brentuximab vedotin and stable background immunosuppressive therapy in adult individuals with Diffuse Cutaneous Systemic Sclerosis (dcSSc). Adult male and female participants with dcSSc will be recruited by a collaborative group of clinical sites in the United States. Participants who meet the eligibility criteria will be enrolled without regard to gender, race, or ethnicity. Eligible participants will be randomly assigned to study treatment, either brentuximab vedotin or placebo equivalent in a 6:2 ratio favoring brentuximab vedotin. Three dose cohorts are planned with 8 participants in each cohort, for a total of 24 participants who receive sufficient doses of the investigational medication to assess safety. The doses planned for each ascending dose cohort include 0.6mg/kg, 1.2 mg/kg, and 1.8 mg/kg brentuximab vedotin or placebo equivalent. All cohorts will receive intravenous administration of study medication every 3 weeks for 21 weeks, for a total of eight doses. Following completion of treatment, participants will undergo follow-up visits at weeks 24, 28, 36 and 48. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03222492
Study type Interventional
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact
Status Completed
Phase Phase 1/Phase 2
Start date September 20, 2017
Completion date April 10, 2023
View Details
See also
  Status Clinical Trial Phase
Completed NCT02798055 - Bosentan Treatment of Digital Ulcers Related to Systemic Sclerosis
Completed NCT01959815 - Novel Screening Strategies for Scleroderma PAH
Completed NCT03274076 - Evaluation of Tofacitinib in Early Diffuse Cutaneous Systemic Sclerosis (dcSSc) Phase 1/Phase 2
Completed NCT02915835 - Riociguat in Scleroderma Associated Digital Ulcers Phase 2
Active, not recruiting NCT01895244 - Autologous Stem Cell Transplantation for Progressive Systemic Sclerosis Phase 2
Completed NCT00930683 - A Study to Evaluate Safety and Tolerability of Multiple Doses of MEDI-546 in Adult Subjects With Scleroderma Phase 1
Completed NCT00883129 - Comparison of Therapeutic Regimens for Scleroderma Interstitial Lung Disease (The Scleroderma Lung Study II) Phase 2
Completed NCT00074568 - Scleroderma Registry
Recruiting NCT04797286 - Sildenafil for Early Pulmonary Vascular Disease in Scleroderma Phase 2
Completed NCT03207997 - MRI Quantification of Pulmonary Fibrosis in Scleroderma Patients N/A
Recruiting NCT04464434 - Upfront Autologous HSCT Versus Immunosuppression in Early Diffuse Cutaneous Systemic Sclerosis Phase 4
Recruiting NCT04246528 - SPIN Self-Management Feasibility Trial With Progression to Full-scale Trial (SPIN-SELF) N/A
Completed NCT05080738 - Upper Extremity Home Exercises in Patients With Scleroderma N/A
Recruiting NCT03726398 - CompRehensive Phenotypic Characterization of Patients With Scleroderma-Associated ILD and PH Phase 2/Phase 3
Recruiting NCT05085444 - A Study of CD19/BCMA Chimeric Antigen Receptor T Cells Therapy for Patients With Refractory Scleroderma Early Phase 1
Completed NCT02062125 - Calcinosis in a Single-Center Scleroderma Population
Completed NCT04588714 - Feasibility and Preliminary Effects of the Resilience-based, Energy Management to Enhance Wellbeing in Systemic Sclerosis (RENEW) Intervention N/A
Recruiting NCT05635266 - Tissue Repository Providing Annotated Biospecimens for Approved Investigator-directed Biomedical Research Initiatives
Completed NCT02835196 - Optical Elastography of Systemic Sclerosis Skin
Completed NCT02896205 - Study to Compare the Efficacy of Mycophenolate Mofetil in Systemic Sclerosis Related Early Interstitial Lung Disease Phase 3