Lupus Nephritis (LN)Phase 3COMPASSNCT05609812
Atacicept in Subjects With Active Lupus Nephritis (COMPASS)
A Phase 3 study testing Atacicept in people with Lupus Nephritis (LN), run by Vera Therapeutics, Inc. at 33 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lupus Nephritis (LN)
- What is being tested?
- Atacicept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 33 sitesin 3 countries
- Study dates
- 2 Nov 2022to 15 Dec 2028
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
33 sites in 3 countries.
33 sites in 3 countries
United States26 sites
Vera Site # 0134
Atlanta, Georgia, 30309
Vera Site # 0137
Augusta, Georgia, 30912
Vera Site # 0144
Augusta, Georgia, 30912
Vera Site # 0109
Chicago, Illinois, 60611
Vera Site # 0148
Cleveland, Ohio, 44109
Vera Site # 0145
Columbus, Ohio, 43210
Vera Site # 0125
Dallas, Texas, 75231
Vera Site # 0126
Dallas, Texas, 75231
Vera Site # 0122
El Paso, Texas, 79925
Vera Site # 0140
Gainesville, Florida, 32610
Vera Site # 0139
Huntsville, Alabama, 35805
Vera SIte # 0132
Jackson, Tennessee, 38305
Vera Site # 0138
La Jolla, California, 92037
Vera Site # 0127
La Palma, California, 90623
Vera Site # 0133
Las Vegas, Nevada, 89106
Vera Site # 0147
Lawrenceville, Georgia, 30046
Vera Site # 0129
Long Beach, California, 90822
Vera Site # 0128
Miami, Florida, 33125
Vera Site # 0143
New Haven, Connecticut, 06520
Vera Site # 0146
New York, New York, 10016
Vera Site # 0142
New York, New York, 10039
Vera Site # 0135
Northridge, California, 91324
Vera Site # 0136
Northridge, California, 91324
Vera Site # 0130
Santa Clarita, California, 91321
Vera Site # 0149
Summit, New Jersey, 07901
Vera Site # 0131
Torrance, California, 90502
Spain6 sites
Vera Site # 0349
A Coruña, 15006
Vera Site # 0348
Barcelona, 08035
Vera Site # 0347
Barcelona, 08036
Vera Site #0351
Santander, 39008
Vera Site # 0350
Seville, 41013
Vera Site # 0346
Valencia, 4601
About this study
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
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.
Read the 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.
- Conditions
- Lupus Nephritis (LN)
- Being tested
- Atacicept, Placebo
- Keywords
- Systemic Lupus erythematosus (SLE), estimated glomerular filtration rate (eGFR), protenuria
- Medical subject headings
- Lupus Nephritis, Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtaciceptDrug
Also called VT-001
Once weekly subcutaneous (SC) injections by prefilled syringe
PlaceboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| Atacicept Dose | Experimental | Atacicept Dose once weekly subcutaneous (SC) Injection Receives: Drug: Atacicept |
| Placebo to match Atacicept | Placebo comparator | Placebo to match Atacicept once weekly subcutaneous (SC) injection Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%
Measured: Week 52
Secondary outcomes (4)
Renal Response with alternative success criteria
Measured: Weeks 52 and 104
Time to UPCR of≤0.5 mg/mg
Measured: Week 52
Renal Response at Week 104
Measured: Week 104
Time to Death or Renal-Related Event
Measured: Week 104
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2022
- Study start2 Nov 2022
- Primary completion15 Mar 2026 (estimated)
- Study completion15 Dec 2028 (estimated)
Why it stopped: Study recruitment is paused due to business reasons, but not due to regulatory or safety concerns.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lupus Nephritis (LN)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vera Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joanne Curley, Study director, Chief Development Officer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05609812
- Sponsor's protocol ID
- VT-001-0070
- Acronym
- COMPASS
- Status last verified
- Oct 2024
- First submitted
- 2 Nov 2022
- Last updated
- 23 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05609812
- Acronym / sponsor ID
- COMPASS / VT-001-0070
- Conditions
- Lupus Nephritis (LN)
- Keywords
- Systemic Lupus erythematosus (SLE), estimated glomerular filtration rate (eGFR), protenuria
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study recruitment is paused due to business reasons, but not due to regulatory or safety concerns.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Vera Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 2 Nov 2022 (actual)
- Primary completion
- 15 Mar 2026 (estimated)
- Study completion
- 15 Dec 2028 (estimated)
- First posted
- 8 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atacicept Dose | Experimental | Drug: AtaciceptAtacicept Dose once weekly subcutaneous (SC) Injection |
| Placebo to match Atacicept | Placebo comparator | Drug: PlaceboPlacebo to match Atacicept once weekly subcutaneous (SC) injection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AtaciceptAlso: VT-001Once weekly subcutaneous (SC) injections by prefilled syringe | Drug | Atacicept Dose |
| Placeboplacebo | Drug | Placebo to match Atacicept |
Primary outcome
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
4 secondary outcomes
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2025.
- Vera Therapeutics, Inc. Company WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joanne Curley study director
Chief Development Officer
33 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Atacicept in people with Lupus Nephritis (LN), run by Vera Therapeutics, Inc. at 33 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 23 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in United States, Spain, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2025; AzTrials last refreshed its copy on 26 Oct 2026.