Trial · NCT03222492

Brentuximab Vedotin for Systemic Sclerosis

NCT03222492, Phase 1, Phase 2, Completed, National Institute of Allergy and Infectious Diseases (NIAID); results first posted 2024-05-17

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Brentuximab Vedotin for Systemic Sclerosis. Trials, record NCT03222492. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03222492

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Brentuximab Vedotin for Systemic Sclerosis
NCT number: NCT03222492
Status: Completed
Phases: Phase 1, Phase 2
Enrollment: 17 participants, actual
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Conditions: Diffuse Cutaneous Systemic Sclerosis, Scleroderma, dcSSc
Interventions: Brentuximab Vedotin, Placebo
First posted: 2017-07-19
Last updated: 2026-05-05
Results first posted: 2024-05-17
Limitations and caveats: Due to slow enrollment the study was stopped before fully enrolling cohort 2 (1.2 mg/kg) and before starting cohort 3 (1.8 mg/kg).

Source ClinicalTrials.gov

Registered outcomes22

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Proportion of Participants That Experience at Least One Grade 3 or Higher Adverse Event at or Before Week 48.	Baseline through end of study (48 weeks for participants who complete the study)	Adverse events were graded using the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, except for the grading of liver chemistry abnormalities. The scale ranges from grade 1 through 5, with grade 1 being the least severe and grade 5 being the most severe. Liver chemistry abnormalities were graded, from 1 through 4 (with 1 being least severe and 4 being most severe) relative to the upper limit of normal (ULN) with different grades depending on whether there was an increase in aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), or blood bilirubin.
Primary	Proportion of Participants That Experience at Least One Grade 3 or Higher Adverse Event at or Before Week 48.	Baseline through end of study (48 weeks)	Adverse events were graded using the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, except for the grading of liver chemistry abnormalities. The scale ranges from grade 1 through 5, with grade 1 being the least severe and grade 5 being the most severe. Liver chemistry abnormalities were graded, from 1 through 4 (with 1 being least severe and 4 being most severe) relative to the upper limit of normal (ULN) with different grades depending on whether there was an increase in aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), or blood bilirubin.
Secondary	Proportion of Participants That Experience at Least One Grade 3 or Higher Adverse Event at or Before Weeks 12, 24, and 36.	Baseline through Week 12 study visit or 12 weeks on study if the visit was missed. Baseline through Week 24 study visit or 24 weeks on study if the visit was missed. Baseline through Week 36 study visit or 36 weeks on study if the visit was missed	Adverse events were graded using the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, except for the grading of liver chemistry abnormalities. The scale ranges from grade 1 through 5, with grade 1 being the least severe and grade 5 being the most severe. Liver chemistry abnormalities were graded, from 1 through 4 (with 1 being least severe and 4 being most severe) relative to the upper limit of normal (ULN) with different grades depending on whether there was an increase in aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), or blood bilirubin.
Secondary	Proportion of Participants That Experience at Least One Grade 3 or Higher Adverse Event at or Before Week12	Baseline through Week 12 study visit or 12 weeks on study if the visit was missed.	Adverse events were graded using the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, except for the grading of liver chemistry abnormalities. The scale ranges from grade 1 through 5, with grade 1 being the least severe and grade 5 being the most severe. Liver chemistry abnormalities were graded, from 1 through 4 (with 1 being least severe and 4 being most severe) relative to the upper limit of normal (ULN) with different grades depending on whether there was an increase in aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), or blood bilirubin.
Secondary	Proportion of Participants That Experience at Least One Grade 3 or Higher Adverse Event at or Before Weeks 24.	Baseline through Week 24 study visit or 24 weeks on study if the visit was missed.	Adverse events were graded using the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, except for the grading of liver chemistry abnormalities. The scale ranges from grade 1 through 5, with grade 1 being the least severe and grade 5 being the most severe. Liver chemistry abnormalities were graded, from 1 through 4 (with 1 being least severe and 4 being most severe) relative to the upper limit of normal (ULN) with different grades depending on whether there was an increase in aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), or blood bilirubin.
Secondary	Proportion of Participants That Experience at Least One Grade 3 or Higher Adverse Event at or Before Weeks 36.	Baseline through Week 36 study visit or 36 weeks on study if the visit was missed.	Adverse events were graded using the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, except for the grading of liver chemistry abnormalities. The scale ranges from grade 1 through 5, with grade 1 being the least severe and grade 5 being the most severe. Liver chemistry abnormalities were graded, from 1 through 4 (with 1 being least severe and 4 being most severe) relative to the upper limit of normal (ULN) with different grades depending on whether there was an increase in aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), or blood bilirubin.
Secondary	Proportion of Participants That Experience at Least One Grade 2 or Higher Adverse Event at or Before Weeks 12, 24, 36, and 48.	Baseline thru Week 12 visit or 12 weeks on study if visit was missed/thru Week 24 visit or 24 weeks on study if visit was missed/thru Week 36 visit or 36 weeks on study if visit was missed/thru Week 48 visit or 48 weeks on study if visit was missed	Adverse events were graded using the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, except for the grading of liver chemistry abnormalities. The scale ranges from grade 1 through 5, with grade 1 being the least severe and grade 5 being the most severe. Liver chemistry abnormalities were graded, from 1 through 4 (with 1 being least severe and 4 being most severe) relative to the upper limit of normal (ULN) with different grades depending on whether there was an increase in aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), or blood bilirubin.
Secondary	Proportion of Participants That Experience at Least One Grade 2 or Higher Adverse Event at or Before Weeks 12	Baseline through the Week 12 study visit or 12 weeks on study if the visit was missed	Adverse events were graded using the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, except for the grading of liver chemistry abnormalities. The scale ranges from grade 1 through 5, with grade 1 being the least severe and grade 5 being the most severe. Liver chemistry abnormalities were graded, from 1 through 4 (with 1 being least severe and 4 being most severe) relative to the upper limit of normal (ULN) with different grades depending on whether there was an increase in aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), or blood bilirubin.
Secondary	Proportion of Participants That Experience at Least One Grade 2 or Higher Adverse Event at or Before Weeks 24.	Baseline through the Week 24 study visit or 24 weeks on study if the visit was missed.	Adverse events were graded using the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, except for the grading of liver chemistry abnormalities. The scale ranges from grade 1 through 5, with grade 1 being the least severe and grade 5 being the most severe. Liver chemistry abnormalities were graded, from 1 through 4 (with 1 being least severe and 4 being most severe) relative to the upper limit of normal (ULN) with different grades depending on whether there was an increase in aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), or blood bilirubin.
Secondary	Proportion of Participants That Experience at Least One Grade 2 or Higher Adverse Event at or Before Weeks 36.	Baseline through the Week 36 study visit or 36 weeks on study if the visit was missed.	Adverse events were graded using the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, except for the grading of liver chemistry abnormalities. The scale ranges from grade 1 through 5, with grade 1 being the least severe and grade 5 being the most severe. Liver chemistry abnormalities were graded, from 1 through 4 (with 1 being least severe and 4 being most severe) relative to the upper limit of normal (ULN) with different grades depending on whether there was an increase in aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), or blood bilirubin.

1 to 10 of 22Source ClinicalTrials.gov

See all 22 registered outcomes

Outcomes23

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Proportion of Participants That Experience at Least One Grade 3 or Higher Adverse Event at or Before Week 48.	Baseline through end of study (48 weeks for participants who complete the study)	The safety population is defined as all participants who receive any amount of the placebo or the brentuximab vedotin study drug. Safety population is conceptually equivalent to the standard intent-to-treat population.	Proportion of participants	NUMBER
PRIMARY	Proportion of Participants That Experience at Least One Grade 3 or Higher Adverse Event at or Before Week 48.	Baseline through end of study (48 weeks)	The Per Protocol 48 (PP48) is defined as the treated participants who receive at least 7 of the 8 infusions over the first 21 weeks, and who have no major protocol deviations that would affect the safety outcomes through the first 48 weeks.	proportion of participants	NUMBER
SECONDARY	Proportion of Participants That Experience at Least One Grade 3 or Higher Adverse Event at or Before Weeks 12, 24, and 36.	Baseline through Week 12 study visit or 12 weeks on study if the visit was missed. Baseline through Week 24 study visit or 24 weeks on study if the visit was missed. Baseline through Week 36 study visit or 36 weeks on study if the visit was missed	The safety population is defined as all participants who receive any amount of the placebo or the brentuximab vedotin study drug. Safety population is conceptually equivalent to the standard intent-to-treat population.	proportion of participants	NUMBER
SECONDARY	Proportion of Participants That Experience at Least One Grade 3 or Higher Adverse Event at or Before Week12	Baseline through Week 12 study visit or 12 weeks on study if the visit was missed.	The Per Protocol 12 (PP12) is defined as the treated participants who receive at least 4 of the 5 infusions over the first 12 weeks, and who have no major protocol deviations that would affect the safety outcomes through the first 12 weeks	proportion of participants	NUMBER
SECONDARY	Proportion of Participants That Experience at Least One Grade 3 or Higher Adverse Event at or Before Weeks 24.	Baseline through Week 24 study visit or 24 weeks on study if the visit was missed.	The Per Protocol 24 (PP24) is defined as the treated participants who receive at least 7 of the 8 infusions over the first 21 weeks, and who have no major protocol deviations that would affect the safety outcomes through the first 24 weeks.	proportion of participants	NUMBER
SECONDARY	Proportion of Participants That Experience at Least One Grade 3 or Higher Adverse Event at or Before Weeks 36.	Baseline through Week 36 study visit or 36 weeks on study if the visit was missed.	The Per Protocol 36 (PP36) is defined as the treated participants who receive at least 7 of the 8 infusions over the first 21 weeks, and who have no major protocol deviations that would affect the safety outcomes through the first 36 weeks.	proportion of participants	NUMBER
SECONDARY	Proportion of Participants That Experience at Least One Grade 2 or Higher Adverse Event at or Before Weeks 12, 24, 36, and 48.	Baseline thru Week 12 visit or 12 weeks on study if visit was missed/thru Week 24 visit or 24 weeks on study if visit was missed/thru Week 36 visit or 36 weeks on study if visit was missed/thru Week 48 visit or 48 weeks on study if visit was missed	The safety population is defined as all participants who receive any amount of the placebo or the brentuximab vedotin study drug. Safety population is conceptually equivalent to the standard intent-to-treat population.	proportion of participants	NUMBER
SECONDARY	Proportion of Participants That Experience at Least One Grade 2 or Higher Adverse Event at or Before Weeks 12	Baseline through the Week 12 study visit or 12 weeks on study if the visit was missed	The Per Protocol 12 (PP12) is defined as the treated participants who receive at least 4 of the 5 infusions over the first 12 weeks, and who have no major protocol deviations that would affect the safety outcomes through the first 12 weeks.	proportion of participants	NUMBER
SECONDARY	Proportion of Participants That Experience at Least One Grade 2 or Higher Adverse Event at or Before Weeks 24.	Baseline through the Week 24 study visit or 24 weeks on study if the visit was missed.	The Per Protocol 24 (PP24) is defined as the treated participants who receive at least 7 of the 8 infusions over the first 21 weeks, and who have no major protocol deviations that would affect the safety outcomes through the first 24 weeks.	proportion of participants	NUMBER
SECONDARY	Proportion of Participants That Experience at Least One Grade 2 or Higher Adverse Event at or Before Weeks 36.	Baseline through the Week 36 study visit or 36 weeks on study if the visit was missed.	The Per Protocol 36 (PP36) is defined as the treated participants who receive at least 7 of the 8 infusions over the first 21 weeks, and who have no major protocol deviations that would affect the safety outcomes through the first 36 weeks.	proportion of participants	NUMBER

1 to 10 of 23Source ClinicalTrials.gov

See all 23 outcomes

Results by group204

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Proportion of Participants That Experience at Least One Grade 3 or Higher Adverse Event at or Before Week 48.	0.6 mg/kg Brentuximab Vedotin	0.333	95% Confidence Interval 0.043 to 0.777	Proportion of participants
Proportion of Participants That Experience at Least One Grade 3 or Higher Adverse Event at or Before Week 48.	0.6 mg/kg Placebo	0.000	95% Confidence Interval 0.000 to 0.842	Proportion of participants
Proportion of Participants That Experience at Least One Grade 3 or Higher Adverse Event at or Before Week 48.	1.2 mg/kg Brentuximab Vedotin	0.571	95% Confidence Interval 0.184 to 0.901	Proportion of participants
Proportion of Participants That Experience at Least One Grade 3 or Higher Adverse Event at or Before Week 48.	1.2 mg/kg Placebo	0.000	95% Confidence Interval 0.000 to 0.842	Proportion of participants
Proportion of Participants That Experience at Least One Grade 3 or Higher Adverse Event at or Before Week 48.	Brentuximab Vedotin in Pooled Participants	0.462	95% Confidence Interval 0.192 to 0.749	Proportion of participants
Proportion of Participants That Experience at Least One Grade 3 or Higher Adverse Event at or Before Week 48.	Placebo in Pooled Participants	0.000	95% Confidence Interval 0.000 to 0.602	Proportion of participants
Proportion of Participants That Experience at Least One Grade 3 or Higher Adverse Event at or Before Week 48.	0.6 mg/kg Brentuximab Vedotin	0.400	95% Confidence Interval 0.053 to 0.853	proportion of participants
Proportion of Participants That Experience at Least One Grade 3 or Higher Adverse Event at or Before Week 48.	0.6 mg/kg Placebo	0.000	95% Confidence Interval 0.000 to 0.842	proportion of participants
Proportion of Participants That Experience at Least One Grade 3 or Higher Adverse Event at or Before Week 48.	1.2 mg/kg Brentuximab Vedotin	0.667	95% Confidence Interval 0.094 to 0.992	proportion of participants
Proportion of Participants That Experience at Least One Grade 3 or Higher Adverse Event at or Before Week 48.	1.2 mg/kg Placebo	0.000	95% Confidence Interval 0.000 to 0.842	proportion of participants

1 to 10 of 204Source ClinicalTrials.gov

See all 204 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Cohort 1 Brentuximab Vedotin	6
Overall Study	STARTED	Cohort 1 Placebo	2
Overall Study	STARTED	Cohort 2 Brentuximab Vedotin	7
Overall Study	STARTED	Cohort 2 Placebo	2
Overall Study	COMPLETED	Cohort 1 Brentuximab Vedotin	6
Overall Study	COMPLETED	Cohort 1 Placebo	2
Overall Study	COMPLETED	Cohort 2 Brentuximab Vedotin	5
Overall Study	COMPLETED	Cohort 2 Placebo	2
Overall Study	NOT COMPLETED	Cohort 1 Brentuximab Vedotin	0
Overall Study	NOT COMPLETED	Cohort 1 Placebo	0

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events258

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Anaemia	Blood and lymphatic system disorders	0.6 mg/kg Brentuximab Vedotin	1	6	1
other	Anaemia	Blood and lymphatic system disorders	0.6 mg/kg Placebo	0	2	0
other	Anaemia	Blood and lymphatic system disorders	1.2 mg/kg Brentuximab Vedotin	1	7	1
other	Anaemia	Blood and lymphatic system disorders	1.2 mg/kg Placebo	0	2	0
other	Anaemia	Blood and lymphatic system disorders	Brentuximab Vedotin in Pooled Participants	2	13	2
other	Anaemia	Blood and lymphatic system disorders	Placebo in Pooled Participants	0	4	0
other	Eosinophilia	Blood and lymphatic system disorders	0.6 mg/kg Brentuximab Vedotin	0	6	0
other	Eosinophilia	Blood and lymphatic system disorders	0.6 mg/kg Placebo	0	2	0
other	Eosinophilia	Blood and lymphatic system disorders	1.2 mg/kg Brentuximab Vedotin	1	7	1
other	Eosinophilia	Blood and lymphatic system disorders	1.2 mg/kg Placebo	0	2	0

1 to 10 of 258Source ClinicalTrials.gov

See all 258 adverse events

Adverse event totals18

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	0.6 mg/kg Brentuximab Vedotin	0	6
Total, all-cause mortality	0.6 mg/kg Placebo	0	2
Total, all-cause mortality	1.2 mg/kg Brentuximab Vedotin	0	7
Total, all-cause mortality	1.2 mg/kg Placebo	0	2
Total, all-cause mortality	Brentuximab Vedotin in Pooled Participants	0	13
Total, all-cause mortality	Placebo in Pooled Participants	0	4
Total, other adverse events	0.6 mg/kg Brentuximab Vedotin	6	6
Total, other adverse events	0.6 mg/kg Placebo	2	2
Total, other adverse events	1.2 mg/kg Brentuximab Vedotin	6	7
Total, other adverse events	1.2 mg/kg Placebo	0	2

1 to 10 of 18Source ClinicalTrials.gov

See all 18 adverse event totals

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
UM1AI109565	Immune Tolerance Network	BUCKNER, JANE HOYT; ANDERSON, MARK S	BENAROYA RESEARCH INST AT VIRGINIA MASON	NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES	2014 to 2025

Source NIH RePORTER

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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