Atacicept in Subjects With Active Lupus Nephritis (COMPASS) (COMPASS)
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| ClinicalTrials.gov Identifier: NCT05609812 |
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Recruitment Status :
Suspended
(Study recruitment is paused due to business reasons, but not due to regulatory or safety concerns.)
First Posted : November 8, 2022
Last Update Posted : July 5, 2023
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Sponsor:
Vera Therapeutics, Inc.
Information provided by (Responsible Party):
Vera Therapeutics, Inc.
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Brief Summary:
The objective of the study is to evaluate the effect of atacicept compared to placebo on changes to renal response in adult subjects with LN.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Lupus Nephritis (LN) | Drug: Atacicept Drug: Placebo | Phase 3 |
The study will assess atacicept vs. placebo on the impact of renal function. Safety and patient reported outcomes will be clinically assessed. The clinical study is comprised of a 104 week double-blind treatment period, followed by a 52 week open-label treatment period and a 26 week safety follow-up period.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 360 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 3 Randomized, Double-Blind, Placebo-Controlled Multicenter, Multinational Study to Evaluate the Efficacy and Safety of Atacicept in Subjects With Active Lupus Nephritis |
| Actual Study Start Date : | November 2, 2022 |
| Estimated Primary Completion Date : | March 15, 2026 |
| Estimated Study Completion Date : | December 15, 2028 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Experimental: Atacicept Dose
Atacicept Dose once weekly subcutaneous (SC) Injection
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Drug: Atacicept
Once weekly subcutaneous (SC) injections by prefilled syringe
Other Name: VT-001 |
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Placebo Comparator: Placebo to match Atacicept
Placebo to match Atacicept once weekly subcutaneous (SC) injection
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Drug: Placebo
placebo |
Primary Outcome Measures :
- Renal Response as definedas UPCR ≤0.5 mg/mg, and eGFR ≥60 mL/min/1.73 m^2 or eGFR <60 mL/min/1.73 m^2 with no confirmed decrease from baseline of >20% [ Time Frame: Week 52 ]
Secondary Outcome Measures :
- Renal Response with alternative success criteria [ Time Frame: Weeks 52 and 104 ]
- Time to UPCR of≤0.5 mg/mg [ Time Frame: Week 52 ]
- Renal Response at Week 104 [ Time Frame: Week 104 ]
- Time to Death or Renal-Related Event [ Time Frame: Week 104 ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Key Inclusion Criteria:
- Male or Female at least 18 years of age at time of signing consent
- Must have the ability to understand and sign and date a written informed consent form
- Diagnosis of SLE
- Biopsy- Proven Active LN
- Requires high-dose corticosteroids and immunosuppressive therapy for the treatment of active LN
- Subject is willing to take oral MMF for the duration of the study
Key Exclusion Criteria:
- eGFR of ≤30 mL/min/1.73 m2.
- Sclerosis in 50% of glomeruli on renal biopsy.
- Evidence of rapidly progressive glomerulonephritis.
- Currently requiring renal dialysis or expected to require dialysis during the study.
- Serum igG <7 g/L
- Active infection or high infectious risk
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05609812
Locations
Show 33 study locations
Sponsors and Collaborators
Vera Therapeutics, Inc.
Investigators
| Study Director: | Joanne Curley | Chief Development Officer |
Additional Information:
| Responsible Party: | Vera Therapeutics, Inc. |
| ClinicalTrials.gov Identifier: | NCT05609812 |
| Other Study ID Numbers: |
VT-001-0070 |
| First Posted: | November 8, 2022 Key Record Dates |
| Last Update Posted: | July 5, 2023 |
| Last Verified: | June 2023 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Vera Therapeutics, Inc.:
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Systemic Lupus erythematosus (SLE) estimated glomerular filtration rate (eGFR) protenuria |
Additional relevant MeSH terms:
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Nephritis Lupus Nephritis Kidney Diseases Urologic Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases |
Male Urogenital Diseases Glomerulonephritis Lupus Erythematosus, Systemic Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |