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Trial record 47 of 906 for:    Lupus

Dose Ranging Study of Brentuximab Vedotin in Adults With Lupus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02533570
Recruitment Status : Terminated (Sponsor decision based on portfolio prioritization)
First Posted : August 27, 2015
Results First Posted : June 11, 2018
Last Update Posted : June 11, 2018
Sponsor:
Information provided by (Responsible Party):
Seattle Genetics, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Systemic Lupus Erythematosus
Interventions Drug: Brentuximab vedotin
Drug: Placebo
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Brentuximab Vedotin 0.3 mg/kg Brentuximab Vedotin 0.6 mg/kg
Hide Arm/Group Description Intravenous (IV) placebo every 3 weeks for a total of 4 doses Intravenous (IV) Brentuximab vedotin (0.3 mg/kg) every 3 weeks for a total of 4 doses Intravenous (IV) Brentuximab vedotin (0.6 mg/kg) every 3 weeks for a total of 4 doses
Period Title: Overall Study
Started 4 8 8
Completed 4 7 7
Not Completed 0 1 1
Reason Not Completed
Adverse Event             0             1             1
Arm/Group Title Placebo Brentuximab Vedotin 0.3 mg/kg Brentuximab Vedotin 0.6 mg/kg Total
Hide Arm/Group Description Intravenous (IV) placebo every 3 weeks for a total of 4 doses Intravenous (IV) Brentuximab vedotin (0.3 mg/kg) every 3 weeks for a total of 4 doses Intravenous (IV) Brentuximab vedotin (0.6 mg/kg) every 3 weeks for a total of 4 doses Total of all reporting groups
Overall Number of Baseline Participants 4 8 8 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4 participants 8 participants 8 participants 20 participants
45.5  (8.66) 50.8  (14.06) 45.0  (11.20) 47.4  (11.78)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 8 participants 8 participants 20 participants
Female
4
 100.0%
8
 100.0%
8
 100.0%
20
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 8 participants 8 participants 20 participants
Hispanic or Latino
1
  25.0%
0
   0.0%
3
  37.5%
4
  20.0%
Not Hispanic or Latino
3
  75.0%
8
 100.0%
5
  62.5%
16
  80.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 8 participants 8 participants 20 participants
American Indian or Alaska Native
0
   0.0%
1
  12.5%
0
   0.0%
1
   5.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
  25.0%
1
  12.5%
5
  62.5%
7
  35.0%
White
3
  75.0%
6
  75.0%
3
  37.5%
12
  60.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 4 participants 8 participants 8 participants 20 participants
4
 100.0%
8
 100.0%
8
 100.0%
20
 100.0%
1.Primary Outcome
Title Number and Percentage of Subjects Having an Adverse Event (AE)
Hide Description Any treatment-emergent adverse events (TEAEs), any drug-related TEAEs, any SAEs, treatment-related serious adverse events (SAE), deaths, adverse events (AEs) leading to study discontinuation, and number of patients experiencing Grade 1, 2, and 3 TEAEs.
Time Frame Up to 127 days (9 weeks after final dose)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Brentuximab Vedotin 0.3 mg/kg Brentuximab Vedotin 0.6 mg/kg
Hide Arm/Group Description:
Intravenous (IV) placebo every 3 weeks for a total of 4 doses
Intravenous (IV) Brentuximab vedotin (0.3 mg/kg) every 3 weeks for a total of 4 doses
Intravenous (IV) Brentuximab vedotin (0.6 mg/kg) every 3 weeks for a total of 4 doses
Overall Number of Participants Analyzed 4 8 8
Measure Type: Count of Participants
Unit of Measure: Participants
Treatment-Emergent Adverse Event
3
  75.0%
6
  75.0%
8
 100.0%
Treatment-Related Adverse Event
0
   0.0%
3
  37.5%
1
  12.5%
Serious Adverse Event
0
   0.0%
1
  12.5%
1
  12.5%
Treatment-Related Serious Adverse Events
0
   0.0%
1
  12.5%
0
   0.0%
Deaths
0
   0.0%
0
   0.0%
0
   0.0%
Adverse Events Leading to Study Discontinuation
0
   0.0%
1
  12.5%
1
  12.5%
Any Grade 1 Adverse Event
2
  50.0%
6
  75.0%
2
  25.0%
Any Grade 2 Adverse Event
2
  50.0%
4
  50.0%
7
  87.5%
Any Grade 3 Adverse Event
0
   0.0%
1
  12.5%
2
  25.0%
2.Secondary Outcome
Title Proportion of Subjects Achieving an SRI Response at Day 85
Hide Description

Assessment for response was made using data only for the visit of interest (Day 85), without regard for changes at prior on-treatment visits.

SRI: SLE Responder Index; SLE: Systemic lupus erythematosus

Time Frame 85 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Brentuximab Vedotin 0.3 mg/kg Brentuximab Vedotin 0.6 mg/kg
Hide Arm/Group Description:
Intravenous (IV) placebo every 3 weeks for a total of 4 doses
Intravenous (IV) Brentuximab vedotin (0.3 mg/kg) every 3 weeks for a total of 4 doses
Intravenous (IV) Brentuximab vedotin (0.6 mg/kg) every 3 weeks for a total of 4 doses
Overall Number of Participants Analyzed 4 7 7
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
1
  14.3%
2
  28.6%
Time Frame Up to 127 days (9 weeks after last dose). The safety reporting period for all AEs and SAEs is from the date of consent through the follow-up visit. All SAEs that occur after the safety reporting period and are considered study treatment-related in the opinion of the Investigator should also be reported to the Sponsor. Additionally, new-onset neuropathy, suspected PML, or other AEs/SAEs of interest are reported until the end of the follow-up period.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Brentuximab Vedotin 0.3 mg/kg Brentuximab Vedotin 0.6 mg/kg
Hide Arm/Group Description Intravenous (IV) placebo every 3 weeks for a total of 4 doses Intravenous (IV) Brentuximab vedotin (0.3 mg/kg) every 3 weeks for a total of 4 doses Intravenous (IV) Brentuximab vedotin (0.6 mg/kg) every 3 weeks for a total of 4 doses
All-Cause Mortality
Placebo Brentuximab Vedotin 0.3 mg/kg Brentuximab Vedotin 0.6 mg/kg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/8 (0.00%)   0/8 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Brentuximab Vedotin 0.3 mg/kg Brentuximab Vedotin 0.6 mg/kg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   1/8 (12.50%)   1/8 (12.50%) 
Injury, poisoning and procedural complications       
Concussion  1  0/4 (0.00%)  0/8 (0.00%)  1/8 (12.50%) 
Respiratory, thoracic and mediastinal disorders       
Dyspnoea  1  0/4 (0.00%)  1/8 (12.50%)  0/8 (0.00%) 
1
Term from vocabulary, MedDRA (18.1)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Brentuximab Vedotin 0.3 mg/kg Brentuximab Vedotin 0.6 mg/kg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/4 (75.00%)   6/8 (75.00%)   8/8 (100.00%) 
Blood and lymphatic system disorders       
Iron Deficiency Anaemia  1  0/4 (0.00%)  0/8 (0.00%)  1/8 (12.50%) 
Gastrointestinal disorders       
Nausea  1  0/4 (0.00%)  2/8 (25.00%)  0/8 (0.00%) 
Abdominal Pain Upper  1  0/4 (0.00%)  1/8 (12.50%)  0/8 (0.00%) 
Diarrhoea  1  0/4 (0.00%)  1/8 (12.50%)  0/8 (0.00%) 
Dyspepsia  1  0/4 (0.00%)  1/8 (12.50%)  0/8 (0.00%) 
Dysphagia  1  0/4 (0.00%)  1/8 (12.50%)  0/8 (0.00%) 
Vomiting  1  0/4 (0.00%)  0/8 (0.00%)  1/8 (12.50%) 
General disorders       
Infusion Site Pain  1  0/4 (0.00%)  1/8 (12.50%)  0/8 (0.00%) 
Infusion Site Pruritus  1  0/4 (0.00%)  1/8 (12.50%)  0/8 (0.00%) 
Non-Cardiac Chest Pain  1  0/4 (0.00%)  1/8 (12.50%)  0/8 (0.00%) 
Oedema Peripheral  1  0/4 (0.00%)  1/8 (12.50%)  0/8 (0.00%) 
Malaise  1  1/4 (25.00%)  0/8 (0.00%)  0/8 (0.00%) 
Infections and infestations       
Bronchitis  1  0/4 (0.00%)  1/8 (12.50%)  1/8 (12.50%) 
Cellulitis  1  0/4 (0.00%)  0/8 (0.00%)  1/8 (12.50%) 
Fungal Infection  1  0/4 (0.00%)  0/8 (0.00%)  1/8 (12.50%) 
Influenza  1  0/4 (0.00%)  1/8 (12.50%)  0/8 (0.00%) 
Pharyngitis  1  0/4 (0.00%)  1/8 (12.50%)  0/8 (0.00%) 
Sinusitis  1  0/4 (0.00%)  1/8 (12.50%)  0/8 (0.00%) 
Tinea Manum  1  0/4 (0.00%)  0/8 (0.00%)  1/8 (12.50%) 
Tinea Pedis  1  0/4 (0.00%)  0/8 (0.00%)  1/8 (12.50%) 
Upper Respiratory Tract Infection  1  0/4 (0.00%)  0/8 (0.00%)  1/8 (12.50%) 
Injury, poisoning and procedural complications       
Avulsion Fracture  1  0/4 (0.00%)  0/8 (0.00%)  1/8 (12.50%) 
Epicondylitis  1  0/4 (0.00%)  1/8 (12.50%)  0/8 (0.00%) 
Fall  1  0/4 (0.00%)  1/8 (12.50%)  0/8 (0.00%) 
Infusion Related Reaction  1  0/4 (0.00%)  1/8 (12.50%)  0/8 (0.00%) 
Tooth Fracture  1  0/4 (0.00%)  1/8 (12.50%)  0/8 (0.00%) 
Musculoskeletal and connective tissue disorders       
Flank Pain  1  1/4 (25.00%)  0/8 (0.00%)  1/8 (12.50%) 
Myalgia  1  0/4 (0.00%)  0/8 (0.00%)  1/8 (12.50%) 
Myositis  1  0/4 (0.00%)  0/8 (0.00%)  1/8 (12.50%) 
Arthritis  1  1/4 (25.00%)  0/8 (0.00%)  0/8 (0.00%) 
Limb Discomfort  1  1/4 (25.00%)  0/8 (0.00%)  0/8 (0.00%) 
Nervous system disorders       
Dizziness  1  0/4 (0.00%)  3/8 (37.50%)  0/8 (0.00%) 
Paraesthesia  1  0/4 (0.00%)  1/8 (12.50%)  0/8 (0.00%) 
Presyncope  1  0/4 (0.00%)  1/8 (12.50%)  0/8 (0.00%) 
Psychiatric disorders       
Mental Status Changes  1  0/4 (0.00%)  1/8 (12.50%)  0/8 (0.00%) 
Depression  1  1/4 (25.00%)  0/8 (0.00%)  0/8 (0.00%) 
Renal and urinary disorders       
Haematuria  1  0/4 (0.00%)  0/8 (0.00%)  1/8 (12.50%) 
Reproductive system and breast disorders       
Ovarian Cyst  1  0/4 (0.00%)  1/8 (12.50%)  0/8 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Asthma  1  0/4 (0.00%)  0/8 (0.00%)  1/8 (12.50%) 
Throat Irritation  1  0/4 (0.00%)  1/8 (12.50%)  0/8 (0.00%) 
Skin and subcutaneous tissue disorders       
Alopecia  1  1/4 (25.00%)  0/8 (0.00%)  1/8 (12.50%) 
Eczema  1  0/4 (0.00%)  1/8 (12.50%)  0/8 (0.00%) 
Hyperhidrosis  1  0/4 (0.00%)  1/8 (12.50%)  0/8 (0.00%) 
Dermal Cyst  1  1/4 (25.00%)  0/8 (0.00%)  0/8 (0.00%) 
Urticaria  1  1/4 (25.00%)  0/8 (0.00%)  0/8 (0.00%) 
Vascular disorders       
Hypotension  1  0/4 (0.00%)  1/8 (12.50%)  0/8 (0.00%) 
Hypertension  1  1/4 (25.00%)  0/8 (0.00%)  0/8 (0.00%) 
Vascular Compression  1  1/4 (25.00%)  0/8 (0.00%)  0/8 (0.00%) 
1
Term from vocabulary, MedDRA (18.1)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days from the time submitted to the sponsor for review. The sponsor may extend the embargo for a period up to 60 days to allow for the filing of a one or more patent applications. The sponsor cannot require changes to the communication and cannot otherwise extend the embargo.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: Seattle Genetics, Inc
Phone: 855-473-2436
EMail: medinfo@seagen.com
Layout table for additonal information
Responsible Party: Seattle Genetics, Inc.
ClinicalTrials.gov Identifier: NCT02533570     History of Changes
Other Study ID Numbers: SGN35-022
First Submitted: July 9, 2015
First Posted: August 27, 2015
Results First Submitted: May 11, 2018
Results First Posted: June 11, 2018
Last Update Posted: June 11, 2018