Systemic Lupus ErythematosusPhase 2NCT02533570

Dose Ranging Study of Brentuximab Vedotin in Adults With Lupus

A Phase 2 study testing Brentuximab vedotin in people with Systemic Lupus Erythematosus, run by Seagen Inc. at 17 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

The purpose of this study is to evaluate the safety and tolerability of brentuximab vedotin in adults with active systemic lupus erythematosus (SLE). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Systemic Lupus Erythematosus
What is being tested?: Brentuximab vedotin
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 20 participants
Where: 17 sitesUnited States
Study dates: Jul 2015to 5 Jun 2017
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Adults ≥ 18 years
Diagnosis of SLE for at least 6 months prior to screening
Active SLE as indicated by SLE Disease Activity Index (SLEDAI) ≥ 4 at screening
Must have failed a treatment for SLE after a trial of at least 3 months

Who cannot join

The subject has any serious health condition, which, in the opinion of the Investigator, would place the subject at undue risk from the study
Subject has had recent serious or ongoing infection, or risk for serious infection
Subject has a history of new or recurrent malignancy within the past 5 years
The subject is pregnant and/or breastfeeding
The subject fulfills diagnostic criteria for another rheumatic (overlap) disease that may confound clinical assessments in the study
The subject has urgent, severe SLE disease activity, which, in the opinion of the Investigator, warrants immediate immunosuppressive therapy and would not be appropriate for the study

Trial locations and contacts

17 sites in 1 country.

City, postcode or hospital

17 sites in 1 country

United States17 sites

Arthritis Clinic of Northern Virginia, PC
Arlington, Virginia, 22205-3606
University of Colorado
Aurora, Colorado, 80045
Tekton Research, Inc.
Austin, Texas, 78745
University of Alabama at Birmingham - (UAB)
Birmingham, Alabama, 35294
Weill Cornell Physicians at Brooklyn Heights
Brooklyn, New York, 11201
DJL Clinical Research, PLLC
Charlotte, North Carolina, 28210
Clinical Research of West Florida - Corporate
Clearwater, Florida, 33765
Henry Ford Health System
Detroit, Michigan, 48202
TriWest Research Associates, LLC
El Cajon, California, 92020-4124
Accurate Clinical Research
Houston, Texas, 77034
Advanced Medical Research, LLC
La Palma, California, 90623
Ramesh C Gupta MD
Memphis, Tennessee, 38119
Lakes Research, LLC
Miami Lakes, Florida, 33014
Arthritis & Rheumatology Center of Oklahoma
Oklahoma City, Oklahoma, 73103
Arthritis Associates
Orlando, Florida, 32804
Clayton Medical Associates, P.C.
St Louis, Missouri, 63117
McIlwain Medical Group
Tampa, Florida, 33613

Other trials in United States

About this study

Official title: A Multi-center, Randomized, Double-blinded, Placebo-controlled, Multiple-ascending-dose Study of Brentuximab Vedotin in Adults With Active Systemic Lupus Erythematosus

The purpose of this study is to evaluate the safety and tolerability of brentuximab vedotin in adults with active systemic lupus erythematosus (SLE).

Read the detailed description

Systemic lupus erythematosus (SLE) is a chronic, multisystem, disabling autoimmune condition, which predominantly affects women of childbearing years. Treatment options for SLE remain relatively limited. Regardless of the specific therapy chosen, the majority of patients continue to require long term immunomodulatory or cytotoxic therapy, resulting in long-term morbidity and mortality. Brentuximab vedotin is an antibody-drug conjugate (ADC) consisting of: 1) the chimeric immunoglobulin (Ig) G1 antibody cAC10, specific for human CD30, 2) the microtubule disrupting agent monomethyl auristatin E (MMAE), and 3) a protease-cleavable linker that covalently attaches MMAE to cAC10. Since CD30 and/or CD30-expressing immune cells may play significant key roles in the pathogenesis of SLE, brentuximab vedotin may be an efficacious therapy. This study intends to explore the potential for brentuximab vedotin as a therapy for SLE.

Conditions: Systemic Lupus Erythematosus
Being tested: Brentuximab vedotin, Placebo
Keywords: Lupus
Medical subject headings: Lupus Erythematosus, Systemic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Brentuximab vedotinDrug
Also called ADCETRIS (brentuximab vedotin)
PlaceboDrug

Study groups in NCT02533570
Study group	Role	What they receive
Brentuximab vedotin	Experimental	4 dose groups Receives: Drug: Brentuximab vedotin
Placebo	Placebo comparator	Matching placebo Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Number and Percentage of Subjects Having an Adverse Event (AE)
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.
Measured: Up to 127 days (9 weeks after final dose)

Secondary outcomes (1)

Proportion of Subjects Achieving an SRI Response at Day 85
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
Measured: 85 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 20155 Jun 2017

First posted27 Aug 2015 (estimated)
Study startJul 2015
Primary completion5 Jun 2017
Study completion5 Jun 2017

Why it stopped: Sponsor decision based on portfolio prioritization

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02533570
Sponsor's protocol ID: SGN35-022
Status last verified: May 2018
First submitted: 9 Jul 2015
Last updated: 11 Jun 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
RecruitingPhase 4
Dapagliflozin in Active Lupus Nephritis
Lupus Nephritis (LN)
RecruitingObservational study
Electroencephalogram Recording in Patients With Systemic Lupus Erythematosus
Systemic Lupus Erythematosus
RecruitingObservational study
Deciphering the Genetic Architecture of Autoimmune Diseases
Autoimmune Diseases
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus

All Systemic Lupus Erythematosus trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-center, Randomized, Double-blinded, Placebo-controlled, Multiple-ascending-dose Study of Brentuximab Vedotin in Adults With Active Systemic Lupus Erythematosus
ClinicalTrials.gov ID: NCT02533570
Acronym / sponsor ID: SGN35-022
Conditions: Systemic Lupus Erythematosus
Keywords: Lupus
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Sponsor decision based on portfolio prioritization
Enrolment: 20 participants (actual)
Lead sponsor: Seagen Inc.Industry (pharma, biotech, devices)
Study start: Jul 2015
Primary completion: 5 Jun 2017 (actual)
Study completion: 5 Jun 2017 (actual)
First posted: 27 Aug 2015 (estimated)
Results: Posted 11 Jun 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to evaluate the safety and tolerability of brentuximab vedotin in adults with active systemic lupus erythematosus (SLE).

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Brentuximab vedotin	Experimental	Drug: Brentuximab vedotin4 dose groups
Placebo	Placebo comparator	Drug: PlaceboMatching placebo

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Adults ≥ 18 years
Diagnosis of SLE for at least 6 months prior to screening
Active SLE as indicated by SLE Disease Activity Index (SLEDAI) ≥ 4 at screening
Must have failed a treatment for SLE after a trial of at least 3 months

Key exclusion criteria (6 listed)

The subject has any serious health condition, which, in the opinion of the Investigator, would place the subject at undue risk from the study
Subject has had recent serious or ongoing infection, or risk for serious infection
Subject has a history of new or recurrent malignancy within the past 5 years
The subject is pregnant and/or breastfeeding
The subject fulfills diagnostic criteria for another rheumatic (overlap) disease that may confound clinical assessments in the study

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Brentuximab vedotinAlso: ADCETRIS (brentuximab vedotin)	Drug	Brentuximab vedotin
Placebo	Drug	Placebo

Primary outcome

Number and Percentage of Subjects Having an Adverse Event (AE)
Time frame: Up to 127 days (9 weeks after final dose)
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.

1 secondary outcome

Proportion of Subjects Achieving an SRI Response at Day 85
Time frame: 85 days

Results and safety

Results posted to the registry on 11 Jun 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	4	4
Brentuximab Vedotin 0.3 mg/kg	8	7
Brentuximab Vedotin 0.6 mg/kg	8	7

Primary outcome: Number and Percentage of Subjects Having an Adverse Event (AE)

Time frame: Up to 127 days (9 weeks after final dose). Count of participants. Unit: Participants

Measure	Placebo n = 4	Brentuximab Vedotin 0.3 mg/kg n = 8	Brentuximab Vedotin 0.6 mg/kg n = 8
Treatment-Emergent Adverse Event	3	6	8
Treatment-Related Adverse Event	0	3	1
Serious Adverse Event	0	1	1
Treatment-Related Serious Adverse Events	0	1	0
Deaths	0	0	0
Adverse Events Leading to Study Discontinuation	0	1	1
Any Grade 1 Adverse Event	2	6	2
Any Grade 2 Adverse Event	2	4	7

1 secondary outcome is reported in the full results.

Adverse events

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.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 4 (0%)	3 of 4 (75%)	0 of 4
Brentuximab Vedotin 0.3 mg/kg	1 of 8 (12.5%)	6 of 8 (75%)	0 of 8
Brentuximab Vedotin 0.6 mg/kg	1 of 8 (12.5%)	8 of 8 (100%)	0 of 8

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Systemic Lupus Erythematosus

Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
RecruitingPhase 4
Dapagliflozin in Active Lupus Nephritis
Lupus Nephritis (LN)
RecruitingObservational study
Electroencephalogram Recording in Patients With Systemic Lupus Erythematosus
Systemic Lupus Erythematosus
RecruitingObservational study
Deciphering the Genetic Architecture of Autoimmune Diseases
Autoimmune Diseases
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Steve Sesterhenn, MD study director

Seattle Genetics Medical Monitor

17 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Brentuximab vedotin in people with Systemic Lupus Erythematosus, run by Seagen Inc. at 17 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 11 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number and Percentage of Subjects Having an Adverse Event (AE) (time frame: Up to 127 days (9 weeks after final dose)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02533570.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2018.