Autoimmune DiseasesPhase 1NCT06413511
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
A Phase 1 study testing Belantamab in people with Autoimmune Diseases, run by GlaxoSmithKline.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Autoimmune Diseases
- What is being tested?
- Belantamab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 3 Jun 2024to 8 Jul 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
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- 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
About this study
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
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.
- Conditions
- Autoimmune Diseases
- Being tested
- Belantamab
- Keywords
- Systemic Lupus Erythematosus, Belantamab (GSK2857914), Autoimmune Disease
- Medical subject headings
- Autoimmune Diseases, Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BelantamabBiological
Also called GSK2857914
Belantamab will be administered
| Study group | Role | What they receive |
|---|---|---|
| Belantamab | Experimental | Not described Receives: Biological: Belantamab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Measured: Up to Week 12
Number of participants with clinically important findings in vital signs
Measured: Up to Week 12
Number of participants with clinically important findings in electrocardiogram
Measured: Up to Week 12
Number of participants with clinically important findings in echocardiogram
Measured: Up to Week 12
Number of participants with clinically important findings in hematology
Measured: Up to Week 12
Number of participants with clinically important findings in clinical chemistry
Measured: Up to Week 12
Number of participants with clinically important findings in urinalysis parameters
Measured: Up to Week 12
Number of participants with clinically important finding in corneal toxicity
Measured: Up to Week 12
Secondary outcomes (6)
Change from Baseline in Immunoglobulin (Ig) M (IgM)
Measured: Baseline (Day 1) and up to Week 12
Area under the concentration-time curve from time 0 to the last quantifiable concentration [AUC(0-t)] of belantamab
Measured: Up to 12 weeks
Area under the concentration-time curve from time 0 to infinity [AUC(0-inf)] of belantamab
Measured: Up to 12 weeks
Maximum observed plasma drug concentration [Cmax] of belantamab
Measured: Up to 12 weeks
Number of participants with Anti-Drug Antibodies (ADAs) against belantamab
Measured: Up to 12 weeks
Titers of ADAs against belantamab
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2024
- Study start3 Jun 2024
- Primary completion8 Jul 2025
- Study completion8 Jul 2025
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune DiseasesStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06413511
- Sponsor's protocol ID
- 221615
- Other IDs
- 2023-510340-20-00, 2023
- Status last verified
- Aug 2025
- First submitted
- 9 May 2024
- Last updated
- 27 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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/
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06413511
- Acronym / sponsor ID
- 221615
- Conditions
- Autoimmune Diseases
- Keywords
- Systemic Lupus Erythematosus, Belantamab (GSK2857914), Autoimmune Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 3 Jun 2024 (actual)
- Primary completion
- 8 Jul 2025 (actual)
- Study completion
- 8 Jul 2025 (actual)
- First posted
- 14 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Belantamab | Experimental | Biological: Belantamab |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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.
Key exclusion criteria (10 listed)
- 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 functional status class IV according to the ACR 1991 revised criteria
- Adult Juvenile RA
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BelantamabAlso: GSK2857914Belantamab will be administered | Biological | Belantamab |
Primary outcome
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Time frame: Up to Week 12
Number of participants with clinically important findings in vital signs
Time frame: Up to Week 12
Number of participants with clinically important findings in electrocardiogram
Time frame: Up to Week 12
Number of participants with clinically important findings in echocardiogram
Time frame: Up to Week 12
Number of participants with clinically important findings in hematology
Time frame: Up to Week 12
Number of participants with clinically important findings in clinical chemistry
Time frame: Up to Week 12
Number of participants with clinically important findings in urinalysis parameters
Time frame: Up to Week 12
Number of participants with clinically important finding in corneal toxicity
Time frame: Up to Week 12
6 secondary outcomes
Change from Baseline in Immunoglobulin (Ig) M (IgM)
Time frame: Baseline (Day 1) and up to Week 12
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
Area under the concentration-time curve from time 0 to infinity [AUC(0-inf)] of belantamab
Time frame: Up to 12 weeks
Maximum observed plasma drug concentration [Cmax] of belantamab
Time frame: Up to 12 weeks
Number of participants with Anti-Drug Antibodies (ADAs) against belantamab
Time frame: Up to 12 weeks
Titers of ADAs against belantamab
Time frame: Up to 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2025.
- Individual participant dataSharing planned: Yes. 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/
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Belantamab in people with Autoimmune Diseases, run by GlaxoSmithKline.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events (AEs) and serious adverse events (SAEs) (time frame: Up to Week 12). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2025.