A Phase 2 interventional study of Brentuximab vedotin and Placebo in Systemic Lupus Erythematosus, sponsored by Seagen Inc.. Terminated at 17 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-06-11.
Sponsored by Seagen Inc. · Phase 2, Interventional, and Treatment
The purpose of this study is to evaluate the safety and tolerability of brentuximab vedotin in adults with active systemic lupus erythematosus (SLE).
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.
1,202 studies on the registry are indexed under Lupus Erythematosus, Systemic; 399 are open to participants now.
This study's enrollment of 20 is below the median of 50 across 867 interventional studies indexed under Lupus Erythematosus, Systemic.
Browse Lupus Erythematosus, Systemic studies →Seagen Inc. is the lead sponsor of 84 studies on the registry; 1 is open to participants now.
Of its 25 completed or terminated interventional studies of FDA-regulated products, 13 (52%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
4 dose groups
Drug: Brentuximab vedotin
Matching placebo
Drug: Placebo
Also known as: ADCETRIS (brentuximab vedotin)
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.
Time frame: Up to 127 days (9 weeks after final dose)
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
Time frame: 85 days
| Milestone | Placebo | Brentuximab Vedotin 0.3 mg/kg | Brentuximab Vedotin 0.6 mg/kg |
|---|---|---|---|
| Started | 4 | 8 | 8 |
| Completed | 4 | 7 | 7 |
| Not completed | 0 | 1 | 1 |
| Withdrew: Adverse event | 0 | 1 | 1 |
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.
| Participants | Placebo | Brentuximab Vedotin 0.3 mg/kg | Brentuximab Vedotin 0.6 mg/kg |
|---|---|---|---|
| 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 |
| Any Grade 3 Adverse Event | 0 | 1 | 2 |
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
| Participants | Placebo | Brentuximab Vedotin 0.3 mg/kg | Brentuximab Vedotin 0.6 mg/kg |
|---|---|---|---|
| Proportion of Subjects Achieving an SRI Response at Day 85 | 0 | 1 | 2 |
Collected over 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.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 0/4 (0%) | 0/4 (0%) | 3/4 (75%) |
| Brentuximab Vedotin 0.3 mg/kg | 0/8 (0%) | 1/8 (12.5%) | 6/8 (75%) |
| Brentuximab Vedotin 0.6 mg/kg | 0/8 (0%) | 1/8 (12.5%) | 8/8 (100%) |
| Event | Placebo | Brentuximab Vedotin 0.3 mg/kg | Brentuximab Vedotin 0.6 mg/kg |
|---|---|---|---|
| ConcussionInjury, poisoning and procedural complications | 0/4 | 0/8 | 1/8 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 0/4 | 1/8 | 0/8 |
| Event | Placebo | Brentuximab Vedotin 0.3 mg/kg | Brentuximab Vedotin 0.6 mg/kg |
|---|---|---|---|
| DizzinessNervous system disorders | 0/4 | 3/8 | 0/8 |
| NauseaGastrointestinal disorders | 0/4 | 2/8 | 0/8 |
| MalaiseGeneral disorders | 1/4 | 0/8 | 0/8 |
| Flank PainMusculoskeletal and connective tissue disorders | 1/4 | 0/8 | 1/8 |
| ArthritisMusculoskeletal and connective tissue disorders | 1/4 | 0/8 | 0/8 |
| Limb DiscomfortMusculoskeletal and connective tissue disorders | 1/4 | 0/8 | 0/8 |
| DepressionPsychiatric disorders | 1/4 | 0/8 | 0/8 |
| AlopeciaSkin and subcutaneous tissue disorders | 1/4 | 0/8 | 1/8 |
| Dermal CystSkin and subcutaneous tissue disorders | 1/4 | 0/8 | 0/8 |
| UrticariaSkin and subcutaneous tissue disorders | 1/4 | 0/8 | 0/8 |
| Age, Continuous(years) | Placebo | Brentuximab Vedotin 0.3 mg/kg | Brentuximab Vedotin 0.6 mg/kg | Total |
|---|---|---|---|---|
| Mean | 45.5 ± 8.66 | 50.8 ± 14.06 | 45.0 ± 11.20 | 47.4 ± 11.78 |
| Sex: Female, Male(Participants) | Placebo | Brentuximab Vedotin 0.3 mg/kg | Brentuximab Vedotin 0.6 mg/kg | Total |
|---|---|---|---|---|
| Female | 4 | 8 | 8 | 20 |
| Male | 0 | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Placebo | Brentuximab Vedotin 0.3 mg/kg | Brentuximab Vedotin 0.6 mg/kg | Total |
|---|---|---|---|---|
| Hispanic or Latino | 1 | 0 | 3 | 4 |
| Not Hispanic or Latino | 3 | 8 | 5 | 16 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Placebo | Brentuximab Vedotin 0.3 mg/kg | Brentuximab Vedotin 0.6 mg/kg | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 0 | 1 |
| Asian | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 1 | 1 | 5 | 7 |
| White | 3 | 6 | 3 | 12 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Placebo | Brentuximab Vedotin 0.3 mg/kg | Brentuximab Vedotin 0.6 mg/kg | Total |
|---|---|---|---|---|
| United States | 4 | 8 | 8 | 20 |
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Lupus Erythematosus, Systemic→
Seagen Inc.