RecruitingPhase 1interventionalRules rewrite

Phase 1: testing Cevostamab for Lupus Erythematosus, Systemic

Q: Is NCT07629583 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

Q: What phase is NCT07629583?

Phase 1. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Q: Can PlainTrials tell me if I qualify for NCT07629583?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

The study will measure the safety, tolerability, pharmacokinetics, and pharmacodynamics of cevostamab in participants with systemic lupus erythematosus (SLE) with or without active lupus nephritis (LN).

Official registry: https://clinicaltrials.gov/study/NCT07629583 · Genentech, Inc. · enrollment listed as 46

What this phase means

Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Cevostamab, or Tocilizumab. The registry lists allocation as na. The study will measure the safety, tolerability, pharmacokinetics, and pharmacodynamics of cevostamab in participants with systemic lupus erythematosus (SLE) with or without active lupus nephritis (LN).

They plan to enroll about 46 people at 11 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

An Open-Label, Multicenter, Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Cevostamab in Patients With Systemic Lupus Erythematosus With or Without Active Lupus Nephritis

Interventions: Cevostamab, Tocilizumab

Primary outcome (registry wording): Percentage of Participants with Adverse Events (AEs)

Who it is for (from inclusion criteria)

Ages 18 Years to 75 Years
Diagnosis of SLE according to the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) Classification Criteria at least 6 months prior to the first screening visit
Active biopsy-proven LN established within 9 months of screening, demonstrating LN per 2018 Revised International Society of Nephrology/Renal Pathology Society (ISN/RPS) criteria
Diagnosis of active SLE disease, as demonstrated by the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score
Inadequate response or intolerance to, in the investigator's judgement, standard of care regimens for active SLE with or without LN

Who the registry excludes

Pregnant or breastfeeding, or intending to become pregnant during the study or within the timeframe in which contraception is required
Treatment with investigational biologic therapies that do not directly deplete B cells (or blinded comparators) is prohibited within 90 days or 5 drug elimination half-lives, whichever is longer, prior to initiation of study drug and during the study
Treatment of SLE/LN with non-investigational biologic therapies that do not directly deplete B cells (e.g., belimumab, anifrolumab) is prohibited within 4 weeks prior to screening and during the study
Treatment with CYC within 3 months prior to screening or during the study
History of known or suspected allergic reaction or anaphylactic reaction to cevostamab or its excipients
Major surgery requiring hospitalization during the 4 weeks prior to screening or during screening, or any planned surgery or procedure requiring hospitalization during the 12 weeks following study drug administration
Alcohol or substance abuse within the 12 months prior to screening

Public study contact (from the registry)

Reference Study ID Number: GA46280 https://forpatients.roche.com/ No attachments to email below.

888-662-6728

global-roche-genentech-trials@gene.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

11 listed

Royal Melbourne Hospital — Parkville, Victoria, Australia (recruiting)
Hospital Moinhos de Vento — Porto Alegre, Rio Grande do Sul, Brazil (recruiting)
Hospital de Clnicas de Porto Alegre — Porto Alegre, Rio Grande do Sul, Brazil (recruiting)
Hospital das Clínicas FMRP-USP — Ribeirão Preto, São Paulo, Brazil (recruiting)
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto — Sao Jose Rio Preto, São Paulo, Brazil (recruiting)
Peking University First Hospital — Beijing, Beijing Municipality, China (recruiting)
Peking University People's Hospital — Beijing, Beijing Municipality, China (recruiting)
Pingxiang People's Hospital — Pingxiang, Jiangxi, China (recruiting)
Hopital Rangueil — Toulouse, Haute Garonne, France (recruiting)
Istituto Clinico Humanitas — Rozzano, Lombardy, Italy (recruiting)
Hospital Universitario Virgen Macarena — Seville, Spain (recruiting)

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FAQ about this NCT record

Is NCT07629583 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07629583?

Phase 1. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07629583?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary