Recent Updates
Recently added Catalysts

GSK3888130B

Phase 1

Multiple Sclerosis | Small molecule | Immunology |GSK plc|Last Updated: Mar 26, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment54
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05131971A Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics (PD) of GSK3888130B in Healthy ParticipantsPHASE1 COMPLETED 54Nov 1, 2021Oct 12, 2023Mar 26, 20251 United Kingdom
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Up to 160 days

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is any serious adverse event that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment.

Number of Participants With Clinically Significant Changes in Hematology Results
Up to 85 days

Blood samples were collected for analysis of following hematology parameters: Basophils, Eosinophils, Hematocrit, Hemoglobin (Hg), Lymphocytes, Mean corpuscular Hg, Mean corpuscular volume, Monocytes, Platelet count, Red blood cell count, Reticulocytes, Total Neutrophils, and White blood cells count (WBC). Number of participants with clinically significant changes in hematology were reported. Clinical significance was determined by the investigator.

Number of Participants With Worst-case Cluster of Differentiation (CD) 4+ T Cell Counts Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Baseline (Day 1) and up to 85 days

Blood samples were collected for the analysis of CD4+ T Cell Counts. The CD4+ T Cell Counts were graded according to National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE). Grade 0: Above 0.5\*10\^9 cells/Liter (L), Grade 1: \<0.5 to 0.2\*10\^9 cells/L, Grade 2: \<0.2 to 0.05\*10\^9 cells/L, Grade 3: Below 0.05\*10\^9 cells/L. Baseline was defined as the latest pre-dose assessment. An increase was defined as an increase in grade relative to Baseline grade. Any worst-case post Baseline increase to Grade 1, Grade 2 and Grade 3 are presented.

Number of Participants With Worst-case Creatinine Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Baseline (Day 1) and up to 85 days

Blood samples were collected for the analysis of Creatinine. Creatinine was graded according to the NCI-CTCAE. Grade 0: \<1.5\* Baseline, or increase from Baseline \<26 micromoles per liter (umol/L), Grade 1: 1.5 to 1.9\* Baseline, or increase from Baseline \>=26 umol/L, Grade 2: 2.0 to 2.9\* Baseline, Grade 3: \>=3.0\* Baseline, or \>=354 umol/L. Baseline was defined as the latest pre-dose assessment. An increase was defined as an increase in grade relative to Baseline grade. Any worst-case post Baseline increase to Grade 1, Grade 2 and Grade 3 are presented.

Number of Participants With Clinically Significant Changes in Clinical Chemistry Results
Up to 85 days

Blood samples were collected for analysis of following clinical chemistry parameters: Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Calcium, Total and Direct bilirubin, Glucose, Potassium, Sodium, Total protein, Lactate dehydrogenase, Haptoglobins and Urea. Number of participants with clinically significant changes in clinical chemistry were reported. Clinical significance was determined by the investigator.

Number of Participants With Worst-case Any Increase in Urinalysis Results Post-Baseline Relative to Baseline
Baseline (Day 1) and up to 85 days

Urine samples were collected for analysis of Specific gravity, potential of hydrogen (pH), glucose, protein, erythrocytes, ketones, bilirubin, urobilinogen, nitrite, and leukocyte in urine by dipstick. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters can be read as negative, trace, 1+, 2+, 3+ indicating proportional concentrations in the urine sample. Any increase means any increase to trace, 1+, 2+ or 3+ post-Baseline relative to Baseline. Baseline was defined as the latest pre-dose assessment. Number of participants with worst-case any increase in urinalysis results post-Baseline relative to Baseline has been presented.

Number of Participants With Clinically Significant Changes in Vital Sign Results
Up to 85 days

Vital signs included systolic and diastolic blood pressure, pulse and respiratory rate and were measured with the participant in semi-supine position after 5 minutes rest. Temperature was also measured as a vital sign but did not require positioning or rest prior to measuring. Clinical significance was determined by the investigator.

Number of Participants With Positive Cytomegalovirus (CMV) Deoxyribonucleic Acid (DNA) and Varicella Zoster Virus (VZV) DNA
Baseline (Day 1), Day 15 and Day 85

VZV-Nucleic acid from blood samples were extracted using the QIASymphony SP followed by TaqMan real time polymerase chain reaction (PCR) for amplification and detection. Murine cytomegalovirus (mCMV) was used as an internal control (IC) and was introduced during the extraction process. CMV-Nucleic acid was extracted using the QIASymphony SP/AS followed by automated set up of Artus real time PCR using the Rotor-Gene Q for amplification and detection. Baseline was defined as the latest pre-dose assessment. Number of participants with Positive CMV DNA and VZV DNA has been presented.

Number of Participants With Positive Epstein-Barr Virus (EBV) DNA
Baseline (Day 1), Day 15 and Day 85

EBV DNA was assessed and qualitative data has been presented. Data has been categorized into 'Positive \>=LLQ' and 'Positive \< LLQ'. LLQ is lower limit of quantification. Participants who had EBV DNA values \>=LLQ were categorized as 'Positive \>=LLQ'. This represents a positive result that is above the assay limit of quantification. Participants who had EBV DNA values \<LLQ were categorized as 'Positive \<LLQ'. This represents a positive result that is below the assay limit of quantification. Baseline was defined as the latest pre-dose assessment.

Number of Participants With Worst-case Post-Baseline Abnormal Electrocardiogram (ECG) Findings
Up to 85 days

Twelve lead ECGs were obtained using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, and QT corrected interval. Abnormal findings were categorized as clinically significant (CS) and not clinically significant (NCS). Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Data for number of participants with worst case post-Baseline abnormal ECG findings have been presented.

Secondary Endpoints
Serum Concentrations of GSK3888130B for Dose Levels 1, 2 and 4 Intravenous Administration
Day 1: Pre-dose, 15 minutes, 30 minutes, 4, 8, 12, 24, 48 hours; Days 6, 8, 10, 15, 21, 29, 57, and 85
Serum Concentrations of GSK3888130B for Dose Levels 3 and 5 Subcutaneous Administration
Day 1: Pre-dose, 4, 8, 12, 24, 48 hours; Days 6, 8, 10, 15, 21, 29, 57, and 85
Serum Concentrations of GSK3888130B for Dose Levels 6 and 7 IV Administration
Day 1: Pre-dose, 30 minutes, 1 hour, 4, 8, 12, 24, 48 hours; Days 6, 8, 10, 15, 21, 29, 57, and 85
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Cohort 1: Participants receiving GSK3888130B at dose level 1EXPERIMENTAL -
Cohort 1: Participants receiving placeboPLACEBO_COMPARATOR -
Cohort 2: Participants receiving GSK3888130B at dose level 2EXPERIMENTAL -
Cohort 2: Participants receiving placeboPLACEBO_COMPARATOR -
Cohort 3: Participants receiving GSK3888130B at dose level 3EXPERIMENTAL -
Cohort 3: Participants receiving placeboPLACEBO_COMPARATOR -
Cohort 4: Participants receiving GSK3888130B at dose level 4EXPERIMENTAL -
Cohort 4: Participants receiving placeboPLACEBO_COMPARATOR -
Cohort 5: Participants receiving GSK3888130B at dose level 5EXPERIMENTAL -
Cohort 5: Participants receiving placeboPLACEBO_COMPARATOR -
Cohort 6: Participants receiving GSK3888130B at dose level 6EXPERIMENTAL -
Cohort 6: Participants receiving placeboPLACEBO_COMPARATOR -
Cohort 7: Participants receiving GSK3888130B at dose level 7EXPERIMENTAL -
Cohort 7: Participants receiving placeboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
GSK3888130BDRUGGSK3888130B will be administered.
PlaceboDRUGPlacebo will be administered.
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Participant must be 18 to 55 years of age inclusive. * Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring. * Participants with a confirmed positive vaccination statu...

Countries:United Kingdom
Unlock Eligibility Criteria