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Atacicept in Subjects With Active Lupus Nephritis (COMPASS) (COMPASS)

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. Identifier: NCT05609812
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
Information provided by (Responsible Party):
Vera Therapeutics, Inc.

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

Detailed Description:
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.

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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
Experimental: Atacicept Dose
Atacicept Dose once weekly subcutaneous (SC) Injection
Drug: Atacicept
Once weekly subcutaneous (SC) injections by prefilled syringe
Other Name: VT-001

Placebo Comparator: Placebo to match Atacicept
Placebo to match Atacicept once weekly subcutaneous (SC) injection
Drug: Placebo

Primary Outcome Measures :
  1. 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 :
  1. Renal Response with alternative success criteria [ Time Frame: Weeks 52 and 104 ]
  2. Time to UPCR of≤0.5 mg/mg [ Time Frame: Week 52 ]
  3. Renal Response at Week 104 [ Time Frame: Week 104 ]
  4. Time to Death or Renal-Related Event [ Time Frame: Week 104 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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

Key Inclusion Criteria:

  1. Male or Female at least 18 years of age at time of signing consent
  2. Must have the ability to understand and sign and date a written informed consent form
  3. Diagnosis of SLE
  4. Biopsy- Proven Active LN
  5. Requires high-dose corticosteroids and immunosuppressive therapy for the treatment of active LN
  6. Subject is willing to take oral MMF for the duration of the study

Key Exclusion Criteria:

  1. eGFR of ≤30 mL/min/1.73 m2.
  2. Sclerosis in 50% of glomeruli on renal biopsy.
  3. Evidence of rapidly progressive glomerulonephritis.
  4. Currently requiring renal dialysis or expected to require dialysis during the study.
  5. Serum igG <7 g/L
  6. 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 identifier (NCT number): NCT05609812

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Sponsors and Collaborators
Vera Therapeutics, Inc.
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Study Director: Joanne Curley Chief Development Officer
Additional Information:
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Responsible Party: Vera Therapeutics, Inc. 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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Vera Therapeutics, Inc.:
Systemic Lupus erythematosus (SLE)
estimated glomerular filtration rate (eGFR)
Additional relevant MeSH terms:
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Lupus Nephritis
Kidney Diseases
Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Male Urogenital Diseases
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases