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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04126200




Registration number
NCT04126200
Ethics application status
Date submitted
11/10/2019
Date registered
15/10/2019

Titles & IDs
Public title
Platform Study of Belantamab Mafodotin as Monotherapy and in Combination With Anti-cancer Treatments in Participants With Relapsed/Refractory Multiple Myeloma (RRMM)
Scientific title
A Phase I/II, Randomized, Open-label Platform Study Utilizing a Master Protocol to Study Belantamab Mafodotin (GSK2857916) as Monotherapy and in Combination With Anti-Cancer Treatments in Participants With Relapsed/Refractory Multiple Myeloma (RRMM) - DREAMM 5
Secondary ID [1] 0 0
208887
Universal Trial Number (UTN)
Trial acronym
DREAMM5
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Myeloma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Other cancer types

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Treatment: Drugs - Belantamab mafodotin
Treatment: Drugs - GSK3174998
Treatment: Drugs - Feladilimab
Treatment: Drugs - Nirogacestat
Treatment: Drugs - Dostarlimab
Treatment: Drugs - Isatuximab
Treatment: Drugs - Lenalidomide
Treatment: Drugs - Dexamethasone
Treatment: Drugs - Pomalidomide

Experimental: Belantamab mafodotin+GSK3174998 dose exploration (Sub-study 1) -

Experimental: Belantamab mafodotin+feladilimab dose exploration (Sub-study 2) -

Experimental: Belantamab mafodotin+nirogacestat dose exploration(Sub-study 3) -

Experimental: Belantamab mafodotin+dostarlimab dose exploration(Sub-study 4) -

Experimental: Belantamab mafodotin+isatuximab dose exploration (Sub-study 5) -

Experimental: Belantamab mafodotin+ nirogacestat+ lenalidomide+ dexamethasone dose exploration (Sub-study 6) -

Experimental: Belantamab mafodotin+ nirogacestat+ pomalidomide + dexamethasone dose exploration (Sub-study 7) -

Experimental: Belantamab mafodotin+ nirogacestat+ lenalidomide+ dexamethasone dose exploration (Sub-study 8) - This cohort will enroll Northeast Asian participants.

Active comparator: Belantamab mafodotin monotherapy cohort expansion -

Experimental: Belantamab mafodotin+GSK3174998 cohort expansion (Sub-study 1) -

Experimental: Belantamab mafodotin+ feladilimab cohort expansion (Sub-study 2) -

Experimental: Belantamab mafodotin+ nirogacestat cohort expansion (Sub-study 3) -

Experimental: Belantamab mafodotin+ dostarlimab cohort expansion (Sub-study 4) -

Experimental: Belantamab mafodotin+ isatuximab cohort expansion (Sub-study 5) -

Experimental: Belantamab mafodotin+ nirogacestat+ lenalidomide+ dexamethasone cohort expansion (Sub-study 6) -

Experimental: Belantamab mafodotin+ nirogacestat+ pomalidomide + dexamethasone cohort expansion (Sub-study 7) -

Experimental: Belantamab mafodotin+ nirogacestat+ lenalidomide+ dexamethasone cohort expansion (Sub-study 8) - This cohort will enroll Northeast Asian participants.


Treatment: Drugs: Belantamab mafodotin
Belantamab mafodotin will be administered.

Treatment: Drugs: GSK3174998
GSK3174998 will be administered.

Treatment: Drugs: Feladilimab
feladilimab will be administered.

Treatment: Drugs: Nirogacestat
Nirogacestat will be administered.

Treatment: Drugs: Dostarlimab
Dostarlimab will be administered.

Treatment: Drugs: Isatuximab
Isatuximab will be administered.

Treatment: Drugs: Lenalidomide
Lenalidomide will be administered.

Treatment: Drugs: Dexamethasone
Dexamethasone will be administered.

Treatment: Drugs: Pomalidomide
Pomalidomide will be administered.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
DE Phase: Number of participants achieving dose limiting toxicities (DLT)
Timepoint [1] 0 0
Up to 12 months
Primary outcome [2] 0 0
DE Phase: Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Timepoint [2] 0 0
Up to 12 months
Primary outcome [3] 0 0
DE Phase: Number of participants with clinically significant changes in hematology, clinical chemistry and urinalysis lab parameters
Timepoint [3] 0 0
Up to 12 months
Primary outcome [4] 0 0
CE Phase: Number of participants achieving Overall Response Rate (ORR)
Timepoint [4] 0 0
Up to 36 months
Secondary outcome [1] 0 0
DE Phase: Number of participants achieving ORR
Timepoint [1] 0 0
Up to 12 months
Secondary outcome [2] 0 0
CE Phase: Number of participants achieving Clinical Benefit Rate (CBR)
Timepoint [2] 0 0
Up to 36 months
Secondary outcome [3] 0 0
DE Phase: Number of participants achieving Partial Response (PR)
Timepoint [3] 0 0
Up to 12 months
Secondary outcome [4] 0 0
CE Phase: Number of participants achieving PR
Timepoint [4] 0 0
Up to 36 months
Secondary outcome [5] 0 0
DE Phase: Number of participants achieving Very Good Partial Response (VGPR)
Timepoint [5] 0 0
Up to 12 months
Secondary outcome [6] 0 0
CE Phase: Number of participants achieving VGPR
Timepoint [6] 0 0
Up to 36 months
Secondary outcome [7] 0 0
DE Phase: Number of participants achieving Complete Response (CR)
Timepoint [7] 0 0
Up to 12 months
Secondary outcome [8] 0 0
CE Phase: Number of participants achieving CR
Timepoint [8] 0 0
Up to 36 months
Secondary outcome [9] 0 0
DE Phase: Number of participants achieving stringent Complete Response (sCR)
Timepoint [9] 0 0
Up to 12 months
Secondary outcome [10] 0 0
CE Phase: Number of participants achieving sCR
Timepoint [10] 0 0
Up to 36 months
Secondary outcome [11] 0 0
DE Phase: Belantamab mafodotin concentrations when administered in combination with anti-cancer treatments
Timepoint [11] 0 0
Up to 12 months
Secondary outcome [12] 0 0
CE Phase: Belantamab mafodotin concentrations when administered in combination with anti-cancer treatments
Timepoint [12] 0 0
Up to 36 months
Secondary outcome [13] 0 0
DE Phase: GSK3174998 concentration when administered in combination with belantamab mafodotin
Timepoint [13] 0 0
Up to 12 months
Secondary outcome [14] 0 0
CE Phase: GSK3174998 concentration when administered in combination with belantamab mafodotin
Timepoint [14] 0 0
Up to 36 months
Secondary outcome [15] 0 0
DE Phase: Feladilimab concentration when administered in combination with belantamab mafodotin
Timepoint [15] 0 0
Up to 12 months
Secondary outcome [16] 0 0
CE Phase: Feladilimab concentration when administered in combination with belantamab mafodotin
Timepoint [16] 0 0
Up to 36 months
Secondary outcome [17] 0 0
DE Phase: Nirogacestat concentration when administered in combination with belantamab mafodotin
Timepoint [17] 0 0
Up to 12 months
Secondary outcome [18] 0 0
CE Phase: Nirogacestat concentration when administered in combination with belantamab mafodotin
Timepoint [18] 0 0
Up to 36 months
Secondary outcome [19] 0 0
DE Phase: Dostarlimab concentration when administered in combination with belantamab mafodotin
Timepoint [19] 0 0
Up to 12 months
Secondary outcome [20] 0 0
CE Phase: Dostarlimab concentration when administered in combination with belantamab mafodotin
Timepoint [20] 0 0
Up to 36 months
Secondary outcome [21] 0 0
DE Phase: Isatuximab concentration when administered in combination with belantamab mafodotin
Timepoint [21] 0 0
Up to 12 months
Secondary outcome [22] 0 0
CE Phase: Isatuximab concentration when administered in combination with belantamab mafodotin
Timepoint [22] 0 0
Up to 36 months
Secondary outcome [23] 0 0
DE Phase: Concentration of anti-drug antibodies (ADAs) against belantamab mafodotin when administered in combination with anti-cancer treatments
Timepoint [23] 0 0
Up to 12 months
Secondary outcome [24] 0 0
CE Phase: Concentration of ADAs against belantamab mafodotin when administered in combination with anti-cancer treatments
Timepoint [24] 0 0
Up to 36 months
Secondary outcome [25] 0 0
DE Phase: Concentration of ADAs against GSK3174998 when administered in combination with belantamab mafodotin
Timepoint [25] 0 0
Up to 12 months
Secondary outcome [26] 0 0
CE Phase: Concentration of ADAs against GSK3174998 when administered in combination with belantamab mafodotin
Timepoint [26] 0 0
Up to 36 months
Secondary outcome [27] 0 0
DE Phase: Concentration of ADAs against feladilimab when administered in combination with belantamab mafodotin
Timepoint [27] 0 0
Up to 12 months
Secondary outcome [28] 0 0
CE Phase: Concentration of ADAs against feladilimab when administered in combination with belantamab mafodotin
Timepoint [28] 0 0
Up to 36 months
Secondary outcome [29] 0 0
DE Phase: Concentration of ADAs against dostarlimab when administered in combination with belantamab mafodotin
Timepoint [29] 0 0
Up to 12 months
Secondary outcome [30] 0 0
CE Phase: Concentration of ADAs against dostarlimab when administered in combination with belantamab mafodotin
Timepoint [30] 0 0
Up to 36 months
Secondary outcome [31] 0 0
DE Phase: Concentration of ADAs against isatuximab when administered in combination with belantamab mafodotin
Timepoint [31] 0 0
Up to 12 months
Secondary outcome [32] 0 0
CE Phase: Concentration of ADAs against isatuximab when administered in combination with belantamab mafodotin
Timepoint [32] 0 0
Up to 36 months
Secondary outcome [33] 0 0
DE Phase: Number of participants with adverse events of special interest (AESI) for belantamab mafodotin
Timepoint [33] 0 0
Up to 12 months
Secondary outcome [34] 0 0
CE Phase: Number of participants with AESI for belantamab mafodotin
Timepoint [34] 0 0
Up to 36 months
Secondary outcome [35] 0 0
DE Phase: Number of participants with AESI for GSK3174998
Timepoint [35] 0 0
Up to 12 months
Secondary outcome [36] 0 0
CE Phase: Number of participants with AESI for GSK3174998
Timepoint [36] 0 0
Up to 36 months
Secondary outcome [37] 0 0
DE Phase: Number of participants with AESI for Feladilimab
Timepoint [37] 0 0
Up to 12 months
Secondary outcome [38] 0 0
CE Phase: Number of participants with AESI for Feladilimab
Timepoint [38] 0 0
Up to 36 months
Secondary outcome [39] 0 0
DE Phase: Number of participants with AESI for Nirogacestat
Timepoint [39] 0 0
Up to 12 months
Secondary outcome [40] 0 0
CE Phase: Number of participants with AESI for Nirogacestat
Timepoint [40] 0 0
Up to 36 months
Secondary outcome [41] 0 0
DE Phase: Number of participants with AESI for Dostarlimab
Timepoint [41] 0 0
Up to 12 months
Secondary outcome [42] 0 0
CE Phase: Number of participants with AESI for Dostarlimab
Timepoint [42] 0 0
Up to 36 months
Secondary outcome [43] 0 0
DE Phase: Number of participants with AESI for Isatuximab
Timepoint [43] 0 0
Up to 12 months
Secondary outcome [44] 0 0
CE Phase: Number of participants with AESI for Isatuximab
Timepoint [44] 0 0
Up to 36 months
Secondary outcome [45] 0 0
DE Phase: Number of participants with abnormal ocular findings on ophthalmic examination
Timepoint [45] 0 0
Up to 12 months
Secondary outcome [46] 0 0
CE Phase: Number of participants with abnormal ocular findings on ophthalmic examination
Timepoint [46] 0 0
Up to 36 months
Secondary outcome [47] 0 0
CE Phase: Number of participants achieving Progression-free survival (PFS)
Timepoint [47] 0 0
Up to 36 months
Secondary outcome [48] 0 0
CE Phase: Duration of response (DoR)
Timepoint [48] 0 0
Up to 36 months
Secondary outcome [49] 0 0
CE Phase: Time to response (TTR)
Timepoint [49] 0 0
Up to 36 months
Secondary outcome [50] 0 0
CE Phase: Number of participants achieving Overall survival (OS)
Timepoint [50] 0 0
Up to 36 months
Secondary outcome [51] 0 0
CE Phase: Number of participants with AEs and SAEs
Timepoint [51] 0 0
Up to 36 months
Secondary outcome [52] 0 0
CE Phase: Number of participants with AEs leading to discontinuation
Timepoint [52] 0 0
Up to 36 months
Secondary outcome [53] 0 0
CE Phase: Number of participants with dose reduction or delay
Timepoint [53] 0 0
Up to 36 months
Secondary outcome [54] 0 0
CE Phase: Number of participants with clinically significant changes in hematology, clinical chemistry and urinalysis lab parameters
Timepoint [54] 0 0
Up to 36 months

Eligibility
Key inclusion criteria
* Participant must be 18 years of age inclusive or older, at the time of signing the informed consent.
* Participants must have histologically or cytologically confirmed diagnosis of Multiple Myeloma (MM), as defined by the IMWG.
* Participants having at least 3 prior lines of prior anti-myeloma treatments including an immunomodulating agent (IMID) a proteasome inhibitor (PI) and an anti-CD38 monoclonal antibody.
* Participants with a history of autologous stem cell transplant are eligible for study participation when, transplant was >100 days prior to study enrolment and with no active infection(s).
* Participants with Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, unless ECOG less than equal to (<=)2 is due solely to skeletal complications and/or skeletal pain due to MM.
* Participants with measurable disease defined as at least one of the following: Serum M-protein greater than equal to (>=)0.5 gram per deciliter (>=5 gram per liter) or Urine M-protein >=200 milligrams (mg) per 24 hours or Serum free light chain (FLC) assay: Involved FLC level >=10 mg per deciliter (>=100 mg per Liter) and an abnormal serum FLC ratio (<0.26 or >1.65).
* Participants who have tested positive for Hepatitis B core antibody (HBcAb) can be enrolled if the following criteria are met: Serology result HBcAb+, Hepatitis B surface antigen (HBsAg)-; HBV deoxyribonucleic acid (DNA) undetectable during screening.
* Participants who are currently receiving physiological doses oral steroids (<10 mg/day), inhaled steroids or ophthalmalogical steroids.

Inclusion Criteria Specific to Sub-study 6,7, and 8:

* Participants with contraception requirements specific to Sub-study 6, 7, and 8 respectively.
* Participants with platelets value for Adequate Organ System Function is =75 × 10^9/L.

Inclusion Criteria Specific to Sub-study 8:

- In Japan, participants should reside in Japan and be Japanese as defined by having all biological Japanese grandparents. Similarly, in China, subjects should reside in China and be Chinese as defined by having all biological Chinese grandparents.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Participants with current corneal epithelial disease except mild punctate keratopathy.
* Participants with evidence of cardiovascular risk.
* Participants with known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to belantamab mafodotin or any of the components of the study treatment. History of severe hypersensitivity to other mAb.
* Participants with active infection requiring antibiotic, antiviral, or antifungal treatment.
* Participants with other monoclonal antibodies within 30 days or systemic anti-myeloma therapy within <14 days.
* Participants with prior radiotherapy within 2 weeks of start of study therapy.
* Participants with prior allogeneic transplant are prohibited.
* Participants who have received prior Chimeric Antigen T cell therapy (CAR-T) therapy with lymphodepletion with chemotherapy within 3 months of screening.
* Participants with any major surgery (other than bone-stabilizing surgery) within the last 30 days.
* Participants with prior treatment with an investigational agent within 14 days or 5 half-lives of receiving the first dose of study drugs, whichever is shorter.
* Participants with >=grade 3 toxicity considered related to prior check-point inhibitors and that led to treatment discontinuation.
* Participants who have received transfusion of blood products within 2 weeks before the first dose of study drug.
* Participants must not receive live attenuated vaccines within 30 days prior to first dose of study treatment or whilst receiving belantamab mafodotin +- partner agent in any sub-study arm of the platform trial and for at least 70 days following last study treatment.
* Participants with presence of active renal condition (infection, requirement for dialysis or any other condition that could affect participant's safety). Participants with isolated proteinuria resulting from MM.
* Participants with known human immunodeficiency virus (HIV) infection, unless the participant can meet all criteria: a) established anti-retroviral therapy for at least 4 weeks and HIV viral load<400 copies/milliliter (mL) b) cluster of differentiation 4 plus (CD4+) T-cell (CD4+) counts >= 350 cells/microliter (µL) c) No history of Acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections within the last 12 months in which case the participant would be eligible for CE Phase only.

For participants receiving nirogacestat, HIV drugs that are strong Cytochrome P450 3A4 (CYP3A4) inhibitors are prohibited. HIV drugs that are moderate CYP3A4 inhibitors, while permitted, should be co-administered with caution and must be accompanied by nirogacestat dose modifications.

Additional Exclusion Criteria for Sub-study 1 and 2:

* Participants with autoimmune disease (current or history) or syndrome that required systemic treatment within the past 2 years.
* Exclusion for a recent (within the past 6 months) history of symptomatic pericarditis.

Additional Exclusion Criteria for Sub-study 3, 6, 7, and 8:

* Participants with uncontrolled small and/or large intestinal disease.
* Participants with uncontrolled skin disease.
* Participants with any condition causing hypophosphatemia, hypokalemia or hypomagnesemia which is refractory to electrolyte replacement.
* Participants with previous administration of a gamma secretase inhibitor.
* Participants with concomitant administration of a strong CYP3A4 inhibitor or inducer.

Additional Exclusion Criteria for Sub-study 4:

* Participant has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs).
* Participants who have received prior therapy with an anti-programmed death-1 (anti-PD-1), anti-PD-1-ligand-1 (anti-PD-L1), or anti-PD-1 ligand-2 (anti-PD-L2) agent.
* Participant has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment. Use of inhaled steroids, local injection of steroids, and steroid eye drops are allowed.

Additional Exclusion Criteria for Sub-study 5:

* Participants with Severe hypersensitivity to Isatuximab-irfc or to any of its excipients.
* Participants with prior treatment with other anti-CD38 monoclonal antibody within 6 months of the first dose of study drug treatment.
* Participants with known intolerance or hypersensitivity to infused proteins products, sucrose, histidine, and polysorbate 80.

Additional Exclusion Criteria for Sub-study 6, 7, and 8:

* Participants with active or history of venous thromboembolism within the past 3 months.
* Participants with evidence of active mucosal or internal bleeding.
* Participants with contraindications to or are unwilling to undergo protocol-required anti-thrombotic prophylaxis or unable to tolerate antithrombolitic prophalaxis.

Additional Exclusion Criteria for Sub-study 6 and 8:

- Participants who discontinued prior treatment with lenalidomide due to intolerable adverse events.

Additional Exclusion Criteria for Sub-study 7:

- Participants who discontinued prior treatment with pomalidomide due to intolerable adverse events.

Additional Exclusion Criteria for Sub-study 8:

* Pregnant or lactating female or female who are interrupting lactation.
* Previously diagnosed with interstitial lung disease or current complication of interstitial lung disease.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/10/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
12/02/2029
Actual
Sample size
Target
464
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
GSK Investigational Site - Fitzroy
Recruitment hospital [2] 0 0
GSK Investigational Site - Melbourne
Recruitment postcode(s) [1] 0 0
3065 - Fitzroy
Recruitment postcode(s) [2] 0 0
3000 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Georgia
Country [2] 0 0
United States of America
State/province [2] 0 0
Indiana
Country [3] 0 0
United States of America
State/province [3] 0 0
Massachusetts
Country [4] 0 0
United States of America
State/province [4] 0 0
Michigan
Country [5] 0 0
United States of America
State/province [5] 0 0
Texas
Country [6] 0 0
United States of America
State/province [6] 0 0
Wisconsin
Country [7] 0 0
Brazil
State/province [7] 0 0
Bahía
Country [8] 0 0
Brazil
State/province [8] 0 0
Rio Grande Do Sul
Country [9] 0 0
Brazil
State/province [9] 0 0
São Paulo
Country [10] 0 0
Canada
State/province [10] 0 0
Alberta
Country [11] 0 0
Canada
State/province [11] 0 0
British Columbia
Country [12] 0 0
Canada
State/province [12] 0 0
Nova Scotia
Country [13] 0 0
Canada
State/province [13] 0 0
Ontario
Country [14] 0 0
France
State/province [14] 0 0
Lille Cedex
Country [15] 0 0
France
State/province [15] 0 0
Lyon cedex 08
Country [16] 0 0
France
State/province [16] 0 0
Mont-de-Marsan
Country [17] 0 0
France
State/province [17] 0 0
Villejuif Cedex
Country [18] 0 0
Germany
State/province [18] 0 0
Hessen
Country [19] 0 0
Germany
State/province [19] 0 0
Sachsen
Country [20] 0 0
Germany
State/province [20] 0 0
Schleswig-Holstein
Country [21] 0 0
Germany
State/province [21] 0 0
Hamburg
Country [22] 0 0
Greece
State/province [22] 0 0
Athens
Country [23] 0 0
Israel
State/province [23] 0 0
Haifa
Country [24] 0 0
Israel
State/province [24] 0 0
Petach Tikva
Country [25] 0 0
Israel
State/province [25] 0 0
Tel Aviv
Country [26] 0 0
Japan
State/province [26] 0 0
Aichi
Country [27] 0 0
Japan
State/province [27] 0 0
Ehime
Country [28] 0 0
Japan
State/province [28] 0 0
Tokyo
Country [29] 0 0
Korea, Republic of
State/province [29] 0 0
Incheon
Country [30] 0 0
Korea, Republic of
State/province [30] 0 0
Seoul
Country [31] 0 0
Korea, Republic of
State/province [31] 0 0
Ulsan
Country [32] 0 0
Mexico
State/province [32] 0 0
Mexico City
Country [33] 0 0
Netherlands
State/province [33] 0 0
Amsterdam
Country [34] 0 0
Netherlands
State/province [34] 0 0
Dordrecht
Country [35] 0 0
Netherlands
State/province [35] 0 0
Enschede
Country [36] 0 0
Netherlands
State/province [36] 0 0
Leeuwarden
Country [37] 0 0
Netherlands
State/province [37] 0 0
Utrecht
Country [38] 0 0
Norway
State/province [38] 0 0
Oslo
Country [39] 0 0
Poland
State/province [39] 0 0
Gdansk
Country [40] 0 0
Poland
State/province [40] 0 0
Katowice
Country [41] 0 0
Poland
State/province [41] 0 0
Lodz
Country [42] 0 0
Poland
State/province [42] 0 0
Lublin
Country [43] 0 0
Poland
State/province [43] 0 0
Poznan
Country [44] 0 0
Russian Federation
State/province [44] 0 0
Moscow
Country [45] 0 0
Russian Federation
State/province [45] 0 0
St'Petersburg
Country [46] 0 0
Spain
State/province [46] 0 0
Badalona
Country [47] 0 0
Spain
State/province [47] 0 0
Madrid
Country [48] 0 0
Spain
State/province [48] 0 0
Pamplona
Country [49] 0 0
Spain
State/province [49] 0 0
Pozuelo (Madrid)
Country [50] 0 0
Sweden
State/province [50] 0 0
Falun
Country [51] 0 0
Sweden
State/province [51] 0 0
Stockholm

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
US GSK Clinical Trials Call Center
Address 0 0
Country 0 0
Phone 0 0
877-379-3718
Fax 0 0
Email 0 0
GSKClinicalSupportHD@gsk.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
IPD for this study will be made available via the Clinical Study Data Request site.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
Available to whom?
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://clinicalstudydatarequest.com


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04126200