Clinical trial NCT03222492: Brentuximab Vedotin for Systemic Sclerosis
Official title: Evaluation of Brentuximab Vedotin for Diffuse Cutaneous Systemic Sclerosis BRAVOS: A Phase 1/2 Multicenter Randomized, Double Blinded, Safety Study (ITN075AI)
Conditions: Diffuse Cutaneous Systemic Sclerosis
Scleroderma
dcSSc
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.
Interventions:
description: Ascending dose cohorts. All cohorts will receive intravenous administration of study medication every 3 weeks for 21 weeks, for a total of eight doses.
name: Brentuximab Vedotin
other_name: Adcetris®
type: Biological
description: Placebo control for blinding (masking), 0.95% normal saline.
name: Placebo
other_name: Placebo for brentuximab vedotin
type: Biological
Study arms:
design_group_description: This is the first of three ascending dose cohorts. Participants in this cohort will receive 0.6 mg/kg brentuximab vedotin (to a maximum dose 60 mg) every 3 weeks from week 0 (initial dose) to week 21, a total of 8 treatments. Brentuximab vedotin will be administered as an intravenous infusion over 30 minutes.<br/>Cohort 1 Randomization schedule: N=6 assigned to brentuximab vedotin: N=2 assigned to placebo.
design_group_title: Cohort 1: 0.6 mg/kg brentuximab vedotin
design_group_type: Experimental
design_group_description: 0.6 mg/kg placebo (to a maximum dose 60 mg). Participants in this cohort will receive 0.6 mg/kg placebo every 3 weeks from week 0 (initial dose) to week 21, a total of 8 treatments. Placebo will be administered as an intravenous infusion over 30 minutes.<br/>Cohort 1 Randomization schedule: N=6 assigned to brentuximab vedotin: N=2 assigned to placebo.
design_group_title: Cohort 1: placebo
design_group_type: Placebo Comparator
design_group_description: This is the second of three ascending dose cohorts. Participants in this cohort will receive 1.2 mg/kg brentuximab vedotin (to a maximum dose 60 mg) every 3 weeks from week 0 (initial dose) to week 21, a total of 8 treatments. Brentuximab vedotin will be administered as an intravenous infusion over 30 minutes.<br/>Cohort 2 Randomization schedule: N=6 assigned to brentuximab vedotin: N=2 assigned to placebo.
design_group_title: Cohort 2: 1.2 mg/kg brentuximab vedotin
design_group_type: Experimental
design_group_description: 1.2 mg/kg placebo (to a maximum dose 60 mg). Participants in this cohort will receive 1.2 mg/kg placebo every 3 weeks from week 0 (initial dose) to week 21, a total of 8 treatments. Placebo will be administered as an intravenous infusion over 30 minutes.<br/>Cohort 2 Randomization schedule: N=6 assigned to brentuximab vedotin: N=2 assigned to placebo.
design_group_title: Cohort 2: placebo
design_group_type: Placebo Comparator
design_group_description: This is the third/last of three ascending dose cohorts. Participants in this cohort will receive 1.8 mg/kg brentuximab vedotin (to a maximum dose 60 mg) every 3 weeks from week 0 (initial dose) to week 21, a total of 8 treatments. Brentuximab vedotin will be administered as an intravenous infusion over 30 minutes.<br/>Cohort 3 Randomization schedule: N=6 assigned to brentuximab vedotin: N=2 assigned to placebo.
design_group_title: Cohort 3: 1.8 mg/kg brentuximab vedotin
design_group_type: Experimental
design_group_description: 1.8 mg/kg placebo (to a maximum dose 60 mg). Participants in this cohort will receive 1.8 mg/kg placebo every 3 weeks from week 0 (initial dose) to week 21, a total of 8 treatments. Placebo will be administered as an intravenous infusion over 30 minutes.<br/>Cohort 3 Randomization schedule: N=6 assigned to brentuximab vedotin: N=2 assigned to placebo.
design_group_title: Cohort 3: placebo
design_group_type: Placebo Comparator
Sponsor: National Institute of Allergy & Infectious Diseases
Collaborators: Pharmaceutical Product Development LLC
Immune Tolerance Network
Rho Federal Systems Division, Inc.
Seagen, Inc.
Drug name mappings:
name: 维布妥昔单抗
lang: CN
name: Brentuximab Vedotin
lang: EN
name: ブレンツキシマブ ベドチン（遺伝子組換え）
lang: JP