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Atacicept in Subjects With Active Lupus Nephritis (COMPASS)

Sponsor
Vera Therapeutics, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05609812
Collaborator
(none)
360
Enrollment
33
Locations
2
Arms
73.4
Anticipated Duration (Months)
10.9
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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
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.

Study Design

Study Type:
Interventional
Anticipated 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 :
Nov 2, 2022
Anticipated Primary Completion Date :
Mar 15, 2026
Anticipated Study Completion Date :
Dec 15, 2028

Arms and Interventions

Arm Intervention/Treatment
Experimental: Atacicept Dose

Atacicept Dose once weekly subcutaneous (SC) Injection

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

    		•
    Placebo Comparator: Placebo to match Atacicept

    Placebo to match Atacicept once weekly subcutaneous (SC) injection

    Drug: Placebo
    placebo

    Outcome Measures

    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% [Week 52]

    Secondary Outcome Measures

    1. Renal Response with alternative success criteria [Weeks 52 and 104]

    2. Time to UPCR of≤0.5 mg/mg [Week 52]

    3. Renal Response at Week 104 [Week 104]

    4. Time to Death or Renal-Related Event [Week 104]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Vera Site # 0139 Huntsville Alabama United States 35805
    2 Vera Site # 0138 La Jolla California United States 92037
    3 Vera Site # 0127 La Palma California United States 90623
    4 Vera Site # 0129 Long Beach California United States 90822
    5 Vera Site # 0135 Northridge California United States 91324
    6 Vera Site # 0136 Northridge California United States 91324
    7 Vera Site # 0130 Santa Clarita California United States 91321
    8 Vera Site # 0131 Torrance California United States 90502
    9 Vera Site # 0143 New Haven Connecticut United States 06520
    10 Vera Site # 0140 Gainesville Florida United States 32610
    11 Vera Site # 0128 Miami Florida United States 33125
    12 Vera Site # 0134 Atlanta Georgia United States 30309
    13 Vera Site # 0137 Augusta Georgia United States 30912
    14 Vera Site # 0144 Augusta Georgia United States 30912
    15 Vera Site # 0147 Lawrenceville Georgia United States 30046
    16 Vera Site # 0109 Chicago Illinois United States 60611
    17 Vera Site # 0133 Las Vegas Nevada United States 89106
    18 Vera Site # 0149 Summit New Jersey United States 07901
    19 Vera Site # 0146 New York New York United States 10016
    20 Vera Site # 0142 New York New York United States 10039
    21 Vera Site # 0148 Cleveland Ohio United States 44109
    22 Vera Site # 0145 Columbus Ohio United States 43210
    23 Vera SIte # 0132 Jackson Tennessee United States 38305
    24 Vera Site # 0125 Dallas Texas United States 75231
    25 Vera Site # 0126 Dallas Texas United States 75231
    26 Vera Site # 0122 El Paso Texas United States 79925
    27 Vera Site # 0141 Coto Laurel Puerto Rico 00780
    28 Vera Site # 0348 Barcelona Spain 08035
    29 Vera Site # 0347 Barcelona Spain 08036
    30 Vera Site # 0349 Coruna Spain 15006
    31 Vera Site #0351 Santander Spain 39008
    32 Vera Site # 0350 Sevilla Spain 41013
    33 Vera Site # 0346 Valencia Spain 4601

    Sponsors and Collaborators

    • Vera Therapeutics, Inc.

    Investigators

    • Study Director: Joanne Curley, Chief Development Officer

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Vera Therapeutics, Inc.
    ClinicalTrials.gov Identifier:
    NCT05609812
    Other Study ID Numbers:
    • VT-001-0070
    First Posted:
    Nov 8, 2022
    Last Update Posted:
    Dec 9, 2022
    Last Verified:
    Nov 1, 2022
    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)
    protenuria
    Additional relevant MeSH terms:
    Nephritis
    Lupus Nephritis

    Study Results

    No Results Posted as of Dec 9, 2022