NCT06041568

Brief Summary

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).

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Aug 2023

Geographic Reach
3 countries

10 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 15, 2023

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

September 11, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 18, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 27, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 27, 2025

Completed
Last Updated

February 10, 2025

Status Verified

February 1, 2025

Enrollment Period

1.5 years

First QC Date

September 11, 2023

Last Update Submit

February 6, 2025

Conditions

Systemic Lupus ErythematosusLupus Erythematosus

Keywords

LupusSLESevere LupusSevere systemic lupus erythematosusSystemic lupus erythematosus

Outcome Measures

Primary Outcomes (1)

  • Safety and tolerability of imvotamab

    Incidence of adverse events (AEs), serious adverse events (SAEs), including serious infectious events and opportunistic infections

    Up to Week 52

Study Arms (1)

Imvotamab (Dose Escalation)

EXPERIMENTAL

Imvotamab administered intravenously

Drug: Imvotamab

Interventions

ImvotamabDRUG

Administered intravenously

Imvotamab (Dose Escalation)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

TriWest Research Associates

San Diego, California, 92108, United States

Location

East Bay Rheumatology

San Leandro, California, 94578, United States

Location

Omega Research, DeBary

DeBary, Florida, 32713, United States

Location

Integral Rheumatology & Immunology Specialists

Plantation, Florida, 33324, United States

Location

Stryde Research

Allen, Texas, 75013, United States

Location

Precision Comprehensive Clinical Research

Grapevine, Texas, 76051, United States

Location

Prolato Clinical Research Center

Houston, Texas, 77054, United States

Location

Care and Cure Clinic

Houston, Texas, 77090, United States

Location

Niepubliczny Zakład Opieki Zdrowotnej Lecznica MAK-MED w Nadarzynie

Nadarzyn, Poland

Location

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Rebecca Kunder

    IGM Biosciences

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2023

First Posted

September 18, 2023

Study Start

August 15, 2023

Primary Completion

January 27, 2025

Study Completion

January 27, 2025

Last Updated

February 10, 2025

Record last verified: 2025-02

Locations

US(8)KR(1)PL(1)