Last updated: 11/03/2018 21:44:50

A study to evaluate the safety, tolerability, pharmacokinetics (PK), proof of mechanism of GSK2618960 in Primary Sjögren’s Syndrome (pSS)

GSK study ID
201579
Clinicaltrials.gov ID
NCT03239600
EudraCT ID
2016-004258-14
EU CT Number
Not applicable
Trial status
Other
Other
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A two part Phase IIa Study, to Evaluate the Safety and Tolerability, Pharmacokinetics, Proof of Mechanism and Potential for Efficacy of an Anti-IL-7 Receptor-α Monoclonal Antibody (GSK2618960) in the Treatment of Primary Sjögren’s Syndrome
Trial description: This study aims to evaluate the safety, tolerability and PK of repeat dose administration of GSK2618960 in the treatment of pSS. The study will contain two parts, Part I will be open label and Part II will be randomized, double-blind. The minimum duration of Part I & Part II of the study will be 26 and 32 weeks respectively.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:

Number of subjects with Adverse Events (AEs): Part 1

Timeframe: Up to Week 29

Number of subjects with abnormal clinical chemistry values: Part 1

Timeframe: Up to Week 29

Number of subjects with abnormal hematology values: Part 1

Timeframe: Up to Week 29

Number of subjects with abnormal urine analysis values: Part 1

Timeframe: Up to Week 29

Number of subjects with abnormal findings of body temperature: Part 1

Timeframe: Up to Week 29

Number of subjects with abnormal findings of blood pressure: Part 1

Timeframe: Up to Week 29

Number of subjects with abnormal findings of pulse rate: Part 1

Timeframe: Up to Week 29

Number of subjects with abnormal findings of respiratory rate: Part 1

Timeframe: Up to Week 29

Number of subjects with abnormal Electrocardiogram (ECG) findings: Part 1

Timeframe: Up to Week 29

Number of subjects with AEs: Part 2

Timeframe: Up to Week 35

Number of subjects with abnormal clinical chemistry values: Part 2

Timeframe: Up to Week 35

Number of subjects with abnormal hematology values: Part 2

Timeframe: Up to Week 35

Number of subjects with abnormal urine analysis values: Part 2

Timeframe: Up to Week 35

Number of subjects with abnormal findings of body temperature: Part 2

Timeframe: Up to Week 35

Number of subjects with abnormal findings of blood pressure: Part 2

Timeframe: Up to Week 35

Number of subjects with abnormal findings of pulse rate: Part 2

Timeframe: Up to Week 35

Number of subjects with abnormal findings of respiratory rate: Part 2

Timeframe: Up to Week 35

Number of subjects with abnormal ECG findings: Part 2

Timeframe: Up to Week 35

Secondary outcomes:

Plasma concentration of GSK2618960: Part 1

Timeframe: Day 1: post-infusion; Day 15 and 29: pre-infusion; Day 43: Pre and post-infusion; Day 8, 22, 36, 50, 57, 71, 99 and 127

Maximum observed plasma concentration (Cmax) of GSK2618960: Part 1

Timeframe: Day 1: post-infusion; Day 15 and 29: pre-infusion; Day 43: Pre and post-infusion; Day 8, 22, 36, 50, 57, 71, 99 and 127

Minimum observed plasma concentration (Cmin) of GSK2618960: Part 1

Timeframe: Day 1: post-infusion; Day 15 and 29: pre-infusion; Day 43: Pre and post-infusion; Day 8, 22, 36, 50, 57, 71, 99 and 127

Area under the curve (AUC) of GSK2618960: Part 1

Timeframe: Day 1: post-infusion; Day 15 and 29: pre-infusion; Day 43: Pre and post-infusion; Day 8, 22, 36, 50, 57, 71, 99 and 127

Number of incidences of Anti-drug antibody (ADA) formation: Part 1

Timeframe: Up to Week 29

Number of titres of ADA: Part 1

Timeframe: Up to Week 29

Time to onset of ADA: Part 1

Timeframe: Up to Week 29

Number of incidences of ADA neutralization: Part 1

Timeframe: Up to Week 29

Plasma concentration of GSK2618960 : Part 2

Timeframe: Day 1: post-infusion; Day 15, 29, 43, 57: pre-infusion; Day 71: Pre and post-infusion; Day 8, 22, 36, 50, 64, 78, 85, 113 and 169

Cmax of GSK2618960: Part 2

Timeframe: Day 1: post-infusion; Day 15, 29, 43, 57: pre-infusion; Day 71: Pre and post-infusion; Day 8, 22, 36, 50, 64, 78, 85, 113 and 169

Cmin of GSK2618960: Part 2

Timeframe: Day 1: post-infusion; Day 15, 29, 43, 57: pre-infusion; Day 71: Pre and post-infusion; Day 8, 22, 36, 50, 64, 78, 85, 113 and 169

AUC of GSK2618960: Part 2

Timeframe: Day 1: post-infusion; Day 15, 29, 43, 57: pre-infusion; Day 71: Pre and post-infusion; Day 8, 22, 36, 50, 64, 78, 85, 113 and 169

Number of incidences of ADA formation: Part 2

Timeframe: Up to Week 35

Number of titres of ADA: Part 2

Timeframe: Up to Week 35

Time to onset of ADA: Part 2

Timeframe: Up to Week 35

Number of incidences of ADA neutralization: Part 2

Timeframe: Up to Week 35

Receptor occupancy (RO) on circulating T cells: Part 2

Timeframe: Up to Week 35

Percentage inhibition of Signal transducer and activator of transcription 5 (STAT 5) phosphorylation in T cells: Part 2

Timeframe: Up to Week 35

Change from Baseline in Focus score: Part 2

Timeframe: Up to Day 29

Interventions:
  • Drug: GSK2618960 2 mg/kg
  • Drug: Placebo
  • Drug: Methotrexate
    • Enrollment:
    0
    Primary completion date:
    2017-12-10
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Autoimmune Diseases
    Product
    GSK2618960, folic acid, methotrexate
    Collaborators
    Not applicable
    Study date(s)
    September 2017 to October 2017
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 70 years
    Accepts healthy volunteers
    No
    • Part I and Part II: Male and females aged 18-70
    • Part I and Part II: pSS diagnosis according to the American-European Consensus Group Criteria
    • Part I and II: Secondary Sjögren’s Syndrome
    • Part I and II: Receiving cyclophosphamide, other biologic, immunosuppressive or immunomodulatory treatments
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Part I and Part II: Male and females aged 18-70
    • Part I and Part II: pSS diagnosis according to the American-European Consensus Group Criteria
    • Part I and Part II: Documented previous biopsy evidence of salivary gland inflammation consistent with pSS and/or documented history of anti-Ro and/or anti-La antibodies
    • Part II: Has any of the following abnormalities at screening: hypergammaglobulinaemia [serum Immunoglobulin G (IgG) greater than or equal to 16 gram per liter (g/L); Presence of Rheumatoid factor (RF); Anti Nuclear Antibodies (ANA) titer greater than or equal to 320:1.
    • Stimulated whole salivary flow greater than 0.1 milliliter per minute (mL/min) at screening.
    • Symptomatic oral dryness greater than or equal to 5 out of 10 on Visual Analogue Scale (VAS) scale and/or Schirmer test less than 10 millimeter (mm) at screening.
    Exclusion criteria:
    • Part I and II: Secondary Sjögren’s Syndrome
    • Part I and II: Receiving cyclophosphamide, other biologic, immunosuppressive or immunomodulatory treatments
    • Part I and II: Active infections, or history of recurrent infections
    • Part I and II: History of significant medical illness
    • Part I and II: History of lymphoma

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Cambridge, United Kingdom, CB2 0GG
    Status
    Study Complete
    Contact us

    Study documents

    No study documents available.

    Results overview

    Study Results yet to be posted

    Recruitment status
    Other
    Actual primary completion date
    2017-12-10
    Actual study completion date
    2017-12-10

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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