Clinical trial NCT06413511: A Study to Investigate the Safety and Pharmacological Effect of a Single Intravenous Infusion of Belantamab in Male and Female Participants Aged 18 to 75 With Autoimmune Disease
Official title: A Phase 1b, Dose Escalation, Open Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacological Effect of a Single Intravenous Infusion of Belantamab in Participants With Autoimmune Disease
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Autoimmune Diseases
Keywords: Systemic Lupus Erythematosus
Belantamab (GSK2857914)
Autoimmune Disease
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2024-05-14
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to assess the safety and tolerability profile of belantamab. The study will also assess how the levels of belantamab change over time and body's reaction to it in participants with stable but active autoimmune disease.


Eligibility criteria: Inclusion Criteria:

* Body mass index (BMI) from 18 to 40 kilograms per square meter (kg/m\^2) (BMI = weight/height\^2), inclusive, and body weight of \>=40 kilogram (kg)
* IgM \>= lower limit of normal (LLN) (40 milligram per deciliter \[mg/dL\]) at initial screening visit (ISV)

Participants with systemic lupus erythematosus (SLE) must also meet the following inclusion criteria:

* Documented clinical diagnosis of SLE according to the European League Against Rheumatism (EULAR) or American College of Rheumatology (ACR) Classification Criteria
* Positive anti-double stranded deoxyribonucleic acid (anti-dsDNA) autoantibody and/or positive antinuclear antibody (ANA) test results, using central lab test, at ISV.
* SLE Disease Activity Index 2000 (SLEDAI-2K) total score of \>=6 at ISV.
* Failure to adequately respond to at least two immunosuppressive therapies.

Participants with Rheumatoid Arthritis (RA) must also meet the following inclusion Criteria:

* Meets ACR/EULAR 2010 RA Classification Criteria with a duration of RA disease of \>=6 months at time of ISV
* Positive rheumatoid factor (RF) and/or anti-cyclic citrullinated peptide (anti-CCP) test results, using central lab test, at ISV.
* Have moderate to severe active disease as defined by \>=3/68 Tender and \>=3/66 Swollen joint count at ISV and Baseline.
* Failure to adequately respond to at least two immunosuppressive therapies.

Participants with antiphospholipid syndrome (APS) must also meet the following inclusion criteria:

* Documented diagnosis of APS meeting the 2023 ACR/EULAR APS classification criteria
* Positive lupus anticoagulant test or moderate to high titers of positive IgG/IgM anticardiolipin (aCL) or moderate to high titers of IgG/IgM anti-beta2-glycoprotein I antibody using central lab test, at ISV
* Clinical features attributable to antiphospholipid antibodies that are resistant to warfarin and/or heparin:

  * Thrombotic event within last 18 months despite adequate anti-coagulation therapy and/or
  * Persistent thrombocytopenia and/or
  * Persistent autoimmune hemolytic anemia
* Sex and Contraceptive /Barrier requirements for females.

Exclusion criteria:

SLE specific exclusion:

* Any acute, severe lupus related flare during the Screening Period that needs immediate treatment
* Has any unstable or progressive manifestation of SLE
* Significant, likely irreversible organ damage related to SLE

RA specific exclusions:

* RA functional status class IV according to the ACR 1991 revised criteria
* Adult Juvenile RA

APS specific exclusions:

* Acute thrombosis (arterial or venous acute thrombosis diagnosis) less than 30 days before study ISV
* Catastrophic APS classification within the prior 90 days of ISV

Primary outcomes:
measure: Number of participants with adverse events (AEs) and serious adverse events (SAEs)
timeFrame: Up to Week 12
measure: Number of participants with clinically important findings in vital signs
timeFrame: Up to Week 12
measure: Number of participants with clinically important findings in electrocardiogram
timeFrame: Up to Week 12
measure: Number of participants with clinically important findings in echocardiogram
timeFrame: Up to Week 12
measure: Number of participants with clinically important findings in hematology
timeFrame: Up to Week 12
measure: Number of participants with clinically important findings in clinical chemistry
timeFrame: Up to Week 12
measure: Number of participants with clinically important findings in urinalysis parameters
timeFrame: Up to Week 12
measure: Number of participants with clinically important finding in corneal toxicity
timeFrame: Up to Week 12
Secondary outcomes:
measure: Change from Baseline in Immunoglobulin (Ig) M (IgM)
timeFrame: Baseline (Day 1) and up to Week 12
measure: Area under the concentration-time curve from time 0 to the last quantifiable concentration [AUC(0-t)] of belantamab
timeFrame: Up to 12 weeks
measure: Area under the concentration-time curve from time 0 to infinity [AUC(0-inf)] of belantamab
timeFrame: Up to 12 weeks
measure: Maximum observed plasma drug concentration [Cmax] of belantamab
timeFrame: Up to 12 weeks
measure: Number of participants with Anti-Drug Antibodies (ADAs) against belantamab
timeFrame: Up to 12 weeks
measure: Titers of ADAs against belantamab
timeFrame: Up to 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: