Autoimmune DiseasesPhase 2NCT03239600
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), Proof of Mechanism of GSK2618960 in Primary Sjögren's Syndrome (pSS)
A Phase 2 study testing GSK2618960 2 mg/kg and Methotrexate in people with Autoimmune Diseases, run by GlaxoSmithKline at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Autoimmune Diseases
- What is being tested?
- GSK2618960 2 mg/kg and Methotrexate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 Sep 2017to 12 Oct 2017
- Phase
- Phase 2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Autoimmune Diseases
- Being tested
- GSK2618960 2 mg/kg, Placebo, Methotrexate
- Keywords
- Anti-IL-7 Receptor-alpha Monoclonal Antibody, Safety, GSK2618960, Primary Sjögren's Syndrome
- Medical subject headings
- Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK2618960 2 mg/kgDrug
GSK2618960 solution for injection, 100mg/mL is clear to opalescent, colorless to yellow or pale brown liquid.
PlaceboDrug
Placebo solution will be administered by IV infusion.
MethotrexateDrug
MTX dose between 7.5 to 15 mg will be administered in tablet form once in a week till last dose of GSK2618960 to all subjects in Part I and Part II.
| Study group | Role | What they receive |
|---|---|---|
| Part I & II: GSK2618960 2 milligram per kilogram (mg/kg) | Experimental | GSK2618960 2mg/kg will be administered intravenously (IV) with Methotrexate (MTX) Receives: Drug: GSK2618960 2 mg/kg; Drug: Methotrexate |
| Part II: Placebo | Placebo comparator | Placebo will be administered IV with MTX Receives: Drug: Placebo; Drug: Methotrexate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with Adverse Events (AEs): Part 1
An AE is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product.
Measured: Up to Week 29
Number of subjects with abnormal clinical chemistry values: Part 1
Samples for clinical chemistry tests will be collected as a measure of safety
Measured: Up to Week 29
Number of subjects with abnormal hematology values: Part 1
Samples for clinical hematology tests will be collected as a measure of safety
Measured: Up to Week 29
Number of subjects with abnormal urine analysis values: Part 1
Samples for Urine analysis tests will be collected as a measure of safety
Measured: Up to Week 29
Number of subjects with abnormal findings of body temperature: Part 1
Body temperature will be measured in a semi-supine position after at least a 5-minute rest.
Measured: Up to Week 29
Number of subjects with abnormal findings of blood pressure: Part 1
Systolic blood pressure (SBP) and diastolic blood pressure (DBP) will be measured in a semi-supine position after at least a 5-minute rest.
Measured: Up to Week 29
Number of subjects with abnormal findings of pulse rate: Part 1
Pulse rate will be measured in a semi-supine position after at least a 5-minute rest.
Measured: Up to Week 29
Number of subjects with abnormal findings of respiratory rate: Part 1
Respiratory rate will be measured in a semi-supine position after at least a 5-minute rest.
Measured: Up to Week 29
Number of subjects with abnormal Electrocardiogram (ECG) findings: Part 1
Triplicate 12-lead ECGs will be obtained at each time point using an ECG machine
Measured: Up to Week 29
Number of subjects with AEs: Part 2
An AE is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product.
Measured: Up to Week 35
Number of subjects with abnormal clinical chemistry values: Part 2
Samples for clinical chemistry tests will be collected as a measure of safety
Measured: Up to Week 35
Number of subjects with abnormal hematology values: Part 2
Samples for clinical hematology tests will be collected as a measure of safety
Measured: Up to Week 35
Number of subjects with abnormal urine analysis values: Part 2
Samples for Urine analysis tests will be collected as a measure of safety
Measured: Up to Week 35
Number of subjects with abnormal findings of body temperature: Part 2
Body temperature will be measured in a semi-supine position after at least a 5-minute rest.
Measured: Up to Week 35
Number of subjects with abnormal findings of blood pressure: Part 2
SBP and DBP will be measured in a semi-supine position after at least a 5-minute rest.
Measured: Up to Week 35
Number of subjects with abnormal findings of pulse rate: Part 2
Pulse rate will be measured in a semi-supine position after at least a 5-minute rest.
Measured: Up to Week 35
Number of subjects with abnormal findings of respiratory rate: Part 2
Respiratory rate will be measured in a semi-supine position after at least a 5-minute rest.
Measured: Up to Week 35
Number of subjects with abnormal ECG findings: Part 2
Triplicate 12-lead ECGs will be obtained at each time point using an ECG machine
Measured: Up to Week 35
Secondary outcomes (19)
Plasma concentration of GSK2618960: Part 1
Blood samples will be collected prior to start and at the end of infusion at the indicated time points and will be analyzed for PK parameters.
Measured: 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
Blood samples will be collected prior to start and at the end of infusion at the indicated time points and will be analyzed for PK parameters.
Measured: 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
Blood samples will be collected prior to start and at the end of infusion at the indicated time points and will be analyzed for PK parameters.
Measured: 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
Blood samples will be collected prior to start and at the end of infusion at indicated time points and will be analyzed for PK parameters.
Measured: 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
Serum samples will be collected from subjects prior to infusion and various time points post-infusion to carry out immunogenicity and immune-complex analyses.
Measured: Up to Week 29
Number of titres of ADA: Part 1
Serum samples will be collected from subjects prior to infusion and various time points post-infusion to carry out immunogenicity and immune-complex analyses.
Measured: Up to Week 29
Time to onset of ADA: Part 1
Serum samples will be collected from subjects prior to infusion and various time points post-infusion to carry out immunogenicity and immune-complex analyses.
Measured: Up to Week 29
Number of incidences of ADA neutralization: Part 1
Serum samples will be collected from subjects prior to infusion and various time points post-infusion to carry out immunogenicity and immune-complex analyses.
Measured: Up to Week 29
Plasma concentration of GSK2618960 : Part 2
Blood samples will be collected prior to start and at the end of infusion at the indicated time points and will be analyzed for PK parameters
Measured: 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
Blood samples will be collected prior to start and at the end of infusion at the indicated time points and will be analyzed for PK parameters.
Measured: 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
Blood samples will be collected prior to start and at the end of infusion at the indicated time points and will be analyzed for PK parameters.
Measured: 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
Blood samples will be collected prior to start and at the end of infusion at indicated time points and will be analyzed for PK parameters.
Measured: 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
Serum samples will be collected from subjects prior to infusion and various time points post-infusion to carry out immunogenicity and immune-complex analyses.
Measured: Up to Week 35
Number of titres of ADA: Part 2
Serum samples will be collected from subjects prior to infusion and various time points post-infusion to carry out immunogenicity and immune-complex analyses.
Measured: Up to Week 35
Time to onset of ADA: Part 2
Serum samples will be collected from subjects prior to infusion and various time points post-infusion to carry out immunogenicity and immune-complex analyses.
Measured: Up to Week 35
Number of incidences of ADA neutralization: Part 2
Serum samples will be collected from subjects prior to infusion and various time points post-infusion to carry out immunogenicity and immune-complex analyses.
Measured: Up to Week 35
Receptor occupancy (RO) on circulating T cells: Part 2
Blood samples will be collected from subjects at indicated time points to measure IL-7R alpha occupancy levels.
Measured: Up to Week 35
Percentage inhibition of Signal transducer and activator of transcription 5 (STAT 5) phosphorylation in T cells: Part 2
Blood samples will be collected from subjects at indicated time points to measure phosphorylation of STAT 5 in response to ex vivo IL-7 stimulation.
Measured: Up to Week 35
Change from Baseline in Focus score: Part 2
Salivary glands for immunohistochemistry analysis will be evaluated for general appearance and total inflammatory infiltrate (focus score). Salivary gland biopsy will be performed at Baseline and blood samples will be collected at indicated time points.
Measured: Up to Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2017
- Study start19 Sep 2017
- Primary completion12 Oct 2017
- Study completion12 Oct 2017 (estimated)
Why it stopped: The study is stopped for Portfolio prioritization.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a parallel assignment where in Part II of the study, randomized subject will receive GSK2618960 and placebo drug simultaneously.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- 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
- NCT03239600
- Sponsor's protocol ID
- 201579
- Status last verified
- Mar 2018
- First submitted
- 19 Jun 2017
- Last updated
- 7 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03239600
- Acronym / sponsor ID
- 201579
- Conditions
- Autoimmune Diseases
- Keywords
- Anti-IL-7 Receptor-alpha Monoclonal Antibody, Safety, GSK2618960, Primary Sjögren's Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study is stopped for Portfolio prioritization.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 19 Sep 2017 (actual)
- Primary completion
- 12 Oct 2017 (actual)
- Study completion
- 12 Oct 2017 (estimated)
- First posted
- 4 Aug 2017 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a parallel assignment where in Part II of the study, randomized subject will receive GSK2618960 and placebo drug simultaneously.
| Arm | Type | Receives |
|---|---|---|
| Part I & II: GSK2618960 2 milligram per kilogram (mg/kg) | Experimental | Drug: GSK2618960 2 mg/kg, Drug: MethotrexateGSK2618960 2mg/kg will be administered intravenously (IV) with Methotrexate (MTX) |
| Part II: Placebo | Placebo comparator | Drug: Placebo, Drug: MethotrexatePlacebo will be administered IV with MTX |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| GSK2618960 2 mg/kgGSK2618960 solution for injection, 100mg/mL is clear to opalescent, colorless to yellow or pale brown liquid. | Drug | Part I & II: GSK2618960 2 milligram per kilogram (mg/kg) |
| PlaceboPlacebo solution will be administered by IV infusion. | Drug | Part II: Placebo |
| MethotrexateMTX dose between 7.5 to 15 mg will be administered in tablet form once in a week till last dose of GSK2618960 to all subjects in Part I and Part II. | Drug | Part I & II: GSK2618960 2 milligram per kilogram (mg/kg), Part II: Placebo |
Primary outcome
Number of subjects with Adverse Events (AEs): Part 1
Time frame: Up to Week 29
An AE is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product.
Number of subjects with abnormal clinical chemistry values: Part 1
Time frame: Up to Week 29
Samples for clinical chemistry tests will be collected as a measure of safety
Number of subjects with abnormal hematology values: Part 1
Time frame: Up to Week 29
Samples for clinical hematology tests will be collected as a measure of safety
Number of subjects with abnormal urine analysis values: Part 1
Time frame: Up to Week 29
Samples for Urine analysis tests will be collected as a measure of safety
Number of subjects with abnormal findings of body temperature: Part 1
Time frame: Up to Week 29
Body temperature will be measured in a semi-supine position after at least a 5-minute rest.
Number of subjects with abnormal findings of blood pressure: Part 1
Time frame: Up to Week 29
Systolic blood pressure (SBP) and diastolic blood pressure (DBP) will be measured in a semi-supine position after at least a 5-minute rest.
Number of subjects with abnormal findings of pulse rate: Part 1
Time frame: Up to Week 29
Pulse rate will be measured in a semi-supine position after at least a 5-minute rest.
Number of subjects with abnormal findings of respiratory rate: Part 1
Time frame: Up to Week 29
Respiratory rate will be measured in a semi-supine position after at least a 5-minute rest.
Number of subjects with abnormal Electrocardiogram (ECG) findings: Part 1
Time frame: Up to Week 29
Triplicate 12-lead ECGs will be obtained at each time point using an ECG machine
Number of subjects with AEs: Part 2
Time frame: Up to Week 35
An AE is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product.
Number of subjects with abnormal clinical chemistry values: Part 2
Time frame: Up to Week 35
Samples for clinical chemistry tests will be collected as a measure of safety
Number of subjects with abnormal hematology values: Part 2
Time frame: Up to Week 35
Samples for clinical hematology tests will be collected as a measure of safety
Number of subjects with abnormal urine analysis values: Part 2
Time frame: Up to Week 35
Samples for Urine analysis tests will be collected as a measure of safety
Number of subjects with abnormal findings of body temperature: Part 2
Time frame: Up to Week 35
Body temperature will be measured in a semi-supine position after at least a 5-minute rest.
Number of subjects with abnormal findings of blood pressure: Part 2
Time frame: Up to Week 35
SBP and DBP will be measured in a semi-supine position after at least a 5-minute rest.
Number of subjects with abnormal findings of pulse rate: Part 2
Time frame: Up to Week 35
Pulse rate will be measured in a semi-supine position after at least a 5-minute rest.
Number of subjects with abnormal findings of respiratory rate: Part 2
Time frame: Up to Week 35
Respiratory rate will be measured in a semi-supine position after at least a 5-minute rest.
Number of subjects with abnormal ECG findings: Part 2
Time frame: Up to Week 35
Triplicate 12-lead ECGs will be obtained at each time point using an ECG machine
19 secondary outcomes
Plasma concentration of GSK2618960: Part 1
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Up to Week 29
Number of titres of ADA: Part 1
Time frame: Up to Week 29
Time to onset of ADA: Part 1
Time frame: Up to Week 29
Number of incidences of ADA neutralization: Part 1
Time frame: Up to Week 29
Plasma concentration of GSK2618960 : Part 2
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Up to Week 35
Number of titres of ADA: Part 2
Time frame: Up to Week 35
Time to onset of ADA: Part 2
Time frame: Up to Week 35
Number of incidences of ADA neutralization: Part 2
Time frame: Up to Week 35
Receptor occupancy (RO) on circulating T cells: Part 2
Time frame: Up to Week 35
Percentage inhibition of Signal transducer and activator of transcription 5 (STAT 5) phosphorylation in T cells: Part 2
Time frame: Up to Week 35
Change from Baseline in Focus score: Part 2
Time frame: Up to Day 29
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 7 Mar 2018.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GSK2618960 2 mg/kg and Methotrexate in people with Autoimmune Diseases, run by GlaxoSmithKline at 1 site in United Kingdom.
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 6 inclusion and 5 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 7 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 subjects with Adverse Events (AEs): Part 1 (time frame: Up to Week 29). The study lists 18 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 7 Mar 2018.