A Study of Imvotamab in Severe Systemic Lupus Erythematosus

Sponsor

IGM Biosciences, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT06041568

Collaborator

(none)

Enrollment

Locations

Arm

32.5

Anticipated Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Systemic Lupus Erythematosus Lupus Erythematosus	Drug: Imvotamab	Phase 1

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

18 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase 1b, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Imvotamab in Participants With Severe Systemic Lupus Erythematosus Who Have Failed Standard Therapies

Actual Study Start Date :

Aug 15, 2023

Anticipated Primary Completion Date :

Jun 1, 2025

Anticipated Study Completion Date :

May 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Imvotamab (Dose Escalation) Imvotamab administered intravenously	Drug: Imvotamab Administered intravenously

Arm

Intervention/Treatment

Experimental: Imvotamab (Dose Escalation)

Imvotamab administered intravenously

Drug: Imvotamab

Administered intravenously

Outcome Measures

Primary Outcome Measures

Safety and tolerability of imvotamab [Up to Week 52]
Incidence of adverse events (AEs), serious adverse events (SAEs), including serious infectious events and opportunistic infections

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Key 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.

Key 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	East Bay Rheumatology	San Leandro	California	United States	94578
2	Omega Research, DeBary	DeBary	Florida	United States	32713
3	Care and Cure Clinic	Houston	Texas	United States	77090