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
Withdrawn
Withdrawn
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
Observational study model:
Not applicable
Primary completion date:
2017-12-10
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
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Location
GSK Investigational Site
Cambridge, United Kingdom, CB2 0GG
Status
Study Complete
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Study documents

No study documents available.

Results overview

Study Results yet to be posted

Recruitment status
Withdrawn
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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