## Protocol Section
### Identification Module
**NCT ID:** NCT06413511

**Brief Title:** 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 Moderate to Severe Systemic Lupus Erythematosus

**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 Moderate to Severe Systemic Lupus Erythematosus

#### Organization Study ID Info
**ID:** 221615
#### Organization
**Class:** INDUSTRY
**Full Name:** GlaxoSmithKline
### Status Module
#### Completion Date
**Date:** 2025-11-24

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-14

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-09

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-11-24

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-29

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-14
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-09
**Study First Submit QC Date:** 2024-05-09
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** GlaxoSmithKline

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

**Oversight Has DMC:** False

### Description Module

**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 moderate to severe systemic lupus erythematosus (SLE).

### Conditions Module

**Conditions:**

- Systemic Lupus Erythematosus

**Keywords:**

- Systemic Lupus Erythematosus

- Belantamab (GSK2857914)

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SEQUENTIAL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 16

**Type:** ESTIMATED

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Biological: Belantamab

**Label:** Belantamab

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Belantamab

**Description:** Belantamab will be administered.

**Name:** Belantamab

**Other Names:**

- GSK2857914

**Type:** BIOLOGICAL

### Outcomes Module

#### Primary Outcomes

**Measure:** Number of participants with adverse events (AEs) and serious adverse events (SAEs)

**Time Frame:** Up to Week 12

**Measure:** Number of participants with clinically important findings in vital signs

**Time Frame:** Up to Week 12

**Measure:** Number of participants with clinically important findings in electrocardiogram

**Time Frame:** Up to Week 12

**Measure:** Number of participants with clinically important findings in echocardiogram

**Time Frame:** Up to Week 12

**Measure:** Number of participants with clinically important findings in haematology

**Time Frame:** Up to Week 12

**Measure:** Number of participants with clinically important findings in clinical chemistry

**Time Frame:** Up to Week 12

**Measure:** Number of participants with clinically important findings in urinalysis parameters

**Time Frame:** Up to Week 12

**Measure:** Number of participants with clinically important findings in corneal toxicity

**Time Frame:** Up to Week 12

#### Secondary Outcomes

**Measure:** Change from baseline in anti-double stranded deoxyribonucleic acid (anti-dsDNA) autoantibodies

**Time Frame:** Baseline (Day 1) and at Week 6

**Measure:** Area under the concentration-time curve from time 0 to the last quantifiable concentration [AUC(0-t)] of belantamab

**Time Frame:** Up to 12 weeks

**Measure:** Area under the concentration-time curve from time 0 to infinity [AUC(0-inf)] of belantamab

**Time Frame:** Up to 12 weeks

**Measure:** Maximum observed plasma drug concentration [Cmax] of belantamab

**Time Frame:** Up to 12 weeks

**Measure:** Number of participants with Anti-Drug Antibodies (ADAs) against belantamab

**Time Frame:** Up to 12 weeks

**Measure:** Titers of ADAs against belantamab

**Time Frame:** Up to 12 weeks

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Body mass index (BMI) from 18 to 32 kilograms per square meter (kg/m²) (BMI = weight/height\^2), inclusive, and body weight of ≥40 kg
* Documented clinical diagnosis of SLE according to the European League Against Rheumatism (EULAR) or American College of Rheumatology (ACR) Classification Criteria
* Moderate to Severe SLE disease
* Positive anti-dsDNA autoantibody test results
* Sex and Contraceptive/Barrier requirements for males and females

Exclusion Criteria:

* 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
* Major Diseases/Conditions/Morbidities including participants with any uncontrolled medical conditions (other than SLE) that in the opinion of the investigator puts the participant at unacceptable risk

**Maximum Age:** 75 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** GSKClinicalSupportHD@gsk.com

**Name:** US GSK Clinical Trials Call Center

**Phone:** 877-379-3718

**Role:** CONTACT

**Contact 2:**

**Email:** GSKClinicalSupportHD@gsk.com

**Name:** EU GSK Clinical Trials Call Center

**Phone:** +44 (0) 20 89904466

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Medley

**Contacts:**

***Contact 1:***

- **Email:** GSKClinicalSupportHD@gsk.com

- **Name:** US GSK Clinical Trials Call Center

- **Phone:** 877-379-3718

- **Role:** CONTACT

***Contact 2:***

- **Email:** GSKClinicalSupportHD@gsk.com

- **Name:** EU GSK Clinical Trials Call Centre

- **Phone:** +44 (0) 20 8990 4466

- **Role:** CONTACT

***Contact 3:***

- **Name:** Ramon Moreda

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** GSK Investigational Site

**State:** Florida

**Zip:** 33166

**Location 2:**

**City:** Peachtree Corners

**Contacts:**

***Contact 1:***

- **Email:** GSKClinicalSupportHD@gsk.com

- **Name:** US GSK Clinical Trials Call Center

- **Phone:** 877-379-3718

- **Role:** CONTACT

***Contact 2:***

- **Email:** GSKClinicalSupportHD@gsk.com

- **Name:** EU GSK Clinical Trials Call Centre

- **Phone:** +44 (0) 20 8990 4466

- **Role:** CONTACT

***Contact 3:***

- **Name:** Darrell Murray

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** GSK Investigational Site

**State:** Georgia

**Zip:** 30071

**Location 3:**

**City:** Memphis

**Contacts:**

***Contact 1:***

- **Email:** GSKClinicalSupportHD@gsk.com

- **Name:** US GSK Clinical Trials Call Center

- **Phone:** 877-379-3718

- **Role:** CONTACT

***Contact 2:***

- **Email:** GSKClinicalSupportHD@gsk.com

- **Name:** EU GSK Clinical Trials Call Centre

- **Phone:** +44 (0) 20 8990 4466

- **Role:** CONTACT

***Contact 3:***

- **Name:** Ramesh Gupta

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** GSK Investigational Site

**State:** Tennessee

**Zip:** 38119

### IPD Sharing Statement Module

**Access Criteria:** Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.

**Description:** Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

**Info Types:**

- STUDY_PROTOCOL

- SAP

- ICF

- CSR

**IPD Sharing:** YES

**Time Frame:** Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.

**URL:** https://www.gsk.com/en-gb/innovation/trials/data-transparency/

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000003240

- Term: Connective Tissue Diseases

- ID: D000001327

- Term: Autoimmune Diseases

- ID: D000007154

- Term: Immune System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: BC20

- Name: Immune System Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M11177

- Name: Lupus Erythematosus, Systemic

- Relevance: HIGH

- As Found: Systemic Lupus Erythematosus

- ID: M6464

- Name: Connective Tissue Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M4629

- Name: Autoimmune Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000008180

- Term: Lupus Erythematosus, Systemic

### Misc Info Module

- Version Holder: 2024-05-31
