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

• ClinicalTrials.gov Identifier: NCT05609812
• Recruitment Status: Suspended
• First Posted: November 8, 2022
• Last Update Posted: July 5, 2023
• Sponsor: Vera Therapeutics, Inc.
• Information provided by (Responsible Party): Vera Therapeutics, Inc.

Tracking Information

• First Submitted Date: November 2, 2022
• First Posted Date: November 8, 2022
• Last Update Posted Date: July 5, 2023
• Actual Study Start Date: November 2, 2022
• Estimated Primary Completion Date: March 15, 2026 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: December 6, 2022): 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 ]
• Original Primary Outcome Measures (submitted: November 7, 2022): Renal Response [ Time Frame: Week 52 ]

Current Secondary Outcome Measures (submitted: November 7, 2022)

• 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 ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Atacicept in Subjects With Active Lupus Nephritis (COMPASS)
• 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
• 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.
• 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.
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Lupus Nephritis (LN)

Intervention

• Drug: Atacicept
  Once weekly subcutaneous (SC) injections by prefilled syringe
  Other Name: VT-001
• Drug: Placebo
  placebo

Study Arms

• Experimental: Atacicept Dose
  Atacicept Dose once weekly subcutaneous (SC) Injection
  Intervention: Drug: Atacicept
• Placebo Comparator: Placebo to match Atacicept
  Placebo to match Atacicept once weekly subcutaneous (SC) injection
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Suspended
• Estimated Enrollment (submitted: November 7, 2022): 360
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 15, 2028
• Estimated Primary Completion Date: March 15, 2026 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Puerto Rico, Spain, United States

Administrative Information

• NCT Number: NCT05609812
• Other Study ID Numbers: VT-001-0070
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Vera Therapeutics, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Vera Therapeutics, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Joanne Curley; Chief Development Officer

• PRS Account: Vera Therapeutics, Inc.
• Verification Date: June 2023