A Study of Imvotamab in Severe Systemic Lupus Erythematosus

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-15

Study Completion Date

2025-01-27

Brief Summary

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The purpose of this study is to determine the safety and tolerability of imvotamab in patients with severe systemic lupus erythematosus who have failed prior therapies.

Participants will be given imvotamab through a vein (i.e., intravenously).

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Detailed Description

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This is a Phase 1b, randomized, placebo-controlled, multicenter study to determine the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of imvotamab in adult participants with systemic lupus erythematosus (SLE). Approximately 18 participants will be assigned to different sequentially dose escalation cohorts.

Conditions

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Systemic Lupus Erythematosus Lupus Erythematosus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Imvotamab (Dose Escalation)

Imvotamab administered intravenously

Group Type EXPERIMENTAL

Imvotamab

Intervention Type DRUG

Administered intravenously

Interventions

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Imvotamab

Administered intravenously

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 18 years at the time of signing ICF
* Diagnosis of SLE according to the 2019 European League Against Rheumatism/American College of Rheumatology (ACR) Classification Criteria at least 16 weeks or more prior to screening
* Highly active SLE disease, as demonstrated by a total systemic lupus erythematosus disease activity index (SLEDAI-2K) total score of ≥ 10 at screening
* Active SLE disease despite treatment with at least 1 immunosuppressive or biologic standard-of-care agent (e.g., methotrexate, azathioprine, mycophenolate mofetil, belimumab, anifrolumab) determined at the discretion of the investigator after at least 3 months of treatment.
* It must be planned that the background standard-of-care treatment remains at a stable dose throughout the Screening Period and up to Week 8.

Exclusion Criteria

* Pregnant or breastfeeding or intending to become pregnant during the study or within 3 months after the final dose of imvotamab.
* Any lupus-associated neuropsychiatric disease.
* Active lupus nephritis with estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73 m2, calculated according to the Chronic Kidney Disease Epidemiology Collaboration equation, classified as World Health Organization (WHO) Class IV.
* Prednisone-equivalent \> 30 mg/day, including immediate and extended-release oral formulations.
* Drug-induced lupus.
* Participants with a history of catastrophic or severe anti-phospholipid syndrome within 12 months prior to screening.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No