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Study of Ianalumab Versus Placebo in Addition to First-line Corticosteroids in Primary Immune Thrombocytopenia (ITP) (VAYHIT1)

Primary Purpose

Primary Immune Thrombocytopenia (ITP)

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ianalumab
Placebo
Corticosteroids
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Immune Thrombocytopenia (ITP) focused on measuring Primary immune thrombocytopenia (ITP), ianalumab, VAY736, B-cell depletion, B-cell Activating Factor Receptor (BAFF-R) blockade

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Signed informed consent prior to participation in the study. Male or female participants aged 18 years and older on the day of signing informed consent Primary ITP diagnosed within 3 months before initiating first-line ITP therapy (corticosteroids, IVIG) Platelet count below 30 G/L before starting any first-line ITP therapy (corticosteroids, IVIG) Response (platelet count >=50 G/L) to corticosteroids (+/- IVIG) at any time prior to randomization. Note: Platelet count measured within 7 days of platelet transfusion will not be considered as response. Key Exclusion Criteria: Evans syndrome or any other cytopenia Current life-threatening bleeding Previous ITP treatment, including splenectomy, except for corticosteroids and/or IVIG initiated as first-line therapy for up to 28 days before randomization and rescue corticosteroids and/or IVIG given prior to confirmed diagnosis of primary ITP . Prior use of B-cell depleting therapy (e.g., rituximab). Absolute neutrophil count below 1.0 G/L at randomization Participants with concurrent coagulation disorders and/or receiving anti-platelet or anticoagulant medication with an exemption of low dose of acetylsalicylic acid Other protocol-defined Inclusion/Exclusion may apply.

Sites / Locations

  • Napa ResearchRecruiting
  • New Tampa HealthRecruiting
  • Inspira Medical Cent Mullica HillRecruiting
  • Hematology Oncology Association of RocklandRecruiting
  • Cleveland Clinic Foundation .Recruiting
  • Community Cancer Trials of UtahRecruiting
  • Novartis Investigative SiteRecruiting
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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Ianalumab Lower dose

Ianalumab Higher dose

Placebo

Arm Description

Lower dose of ianalumab administered intravenously with corticosteroids oral or parental (if clinically justified)

Higher dose of ianalumab administered intravenously with corticosteroids oral or parental (if clinically justified)

Placebo administered intravenously with corticosteroids oral or parental (if clinically justified)

Outcomes

Primary Outcome Measures

Time from randomization to treatment failure (TTF)
Time from randomization until platelet count below 30 G/L, need for a rescue treatment or start of a second-line therapy or death.

Secondary Outcome Measures

Complete Response (CR) rate in each treatment group
Complete Response (CR) rate at each timepoint defined as the proportion of participants with any platelet count of at least 100 G/L in the absence of rescue treatment or new ITP treatment.
Response (R) rate in each treatment group
Response (R) rate at each timepoint defined as the proportion of participants with any platelet count of at least 50 G/L in the absence of rescue treatment or new ITP treatment.
Time to complete response in each treatment group
Time from randomization to date of first complete response.
Duration of response in each treatment group
Time from achievement of complete response to loss of complete response
Stable response at 6 months
Percentage of participants with at least 2 platelet count collected at month 6 (between study dates 107 and 183) and at least 66% of platelet counts qualified as a response
Stable response at 1 year
Percentage of participants with at least 2 platelet counts collected at year 1 (between study days 296 and 379) and at least 66% of platelet counts qualified as a response
Percentage of participants with bleeding events overall and by World Health Organization (WHO) bleeding scale severity
This is to assess the incidence and severity of bleeding in each treatment arm
Number of participants with bleeding events overall and by World Health Organization (WHO) bleeding scale severity
This is to assess the number and severity of bleeding in each treatment arm
Number of participants receiving rescue treatment (cummulative dose/duration of steroids exposure)
This is to assess the number of participants receiving rescue treatment.
Percentage of participants receiving rescue treatment (cummulative dose/duration of steroids exposure)
This is to assess the need of rescue treatment in each treatment group by percentage.
Cumulative dose/duration of steroids exposure
Duration of exposure to corticosteroids calculated from randomization (first dose) to end of study or last last contact date (if the participant is lost to follow-up).
Change from baseline on total scores of the PROMIS SF v1.0 Fatigue 13a
The Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 Fatigue 13a includes 13 items that assess fatigue
Change from baseline in ITP-PAQ domain scores
The ITP-PAQ is a 44 item scale for measuring HRQoL in adults with ITP across ten scales: Symptoms, Bother-Physical Health, Fatigue/Sleep, Activity, Fear, Psychological Health, Work, Social Activity, Women's Reproductive Health, and Overall QoL. Each item is rated on a Likert type scale
Change from baseline in frequency of CD19+ B cell counts
Post baseline frequency (%within the CD45) of CD19+ B cell counts compare to baseline.
Change from baseline in absolute number of CD19+ B cell counts
Post baseline absolute number of CD19+ B cell counts compare with baseline
Time to first occurrence of B-cell recovery
B-cell recovery, defined as ≥80% of baseline or ≥50 cells/μL
Change from baseline in inmmunoglobulins
Change from baseline in immunoglobulin levels
PK parameters: AUClast
AUClast: area under the curve from time zero till the last measurable concentration sampling time (tlast)
PK parameter: AUCtau
Area under the curve calculated to the end of a dosing interval (tau)
PK parameters: Cmax
Maximum (peak) observed plasma, blood, serum, or other body fluid drug concentration after single dose administration
PK parameters: Tmax
Time to reach maximum (peak) plasma, blood, serum, or other body fluid drug concentration
PK parameters: Accumulation ratio Racc
Accumulation ratio calculated using AUC values obtained between the last and first dose
Incidence of anti-ianalumab antibodies in serum (ADA assay) over time
Anti-drug antibodies (ADA) will be evaluated in samples collected from all participants assess the immunogenicity of ianalumab
Titer of anti-ianalumab antibodies in serum (ADA assay) over time
Anti-drug antibodies (ADA) will be evaluated in samples collected from all participants assess the immunogenicity of ianalumab

Full Information

First Posted
November 23, 2022
Last Updated
October 17, 2023
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT05653349
Brief Title
Study of Ianalumab Versus Placebo in Addition to First-line Corticosteroids in Primary Immune Thrombocytopenia (ITP)
Acronym
VAYHIT1
Official Title
A Phase III, Randomized, Double-blind Study of Ianalumab (VAY736) Versus Placebo in Addition to First-line Corticosteroids in Primary Immune Thrombocytopenia (VAYHIT1)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 6, 2023 (Actual)
Primary Completion Date
September 25, 2025 (Anticipated)
Study Completion Date
February 4, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate the effect of two different doses of ianalumab versus placebo in addition to first-line corticosteroids in maintaining platelet count ≥30 G/L in adult participants with primary ITP.
Detailed Description
This is a multi-center, randomized, double-blind Phase 3 study to assess the efficacy and safety of two different doses of ianalumab compared to placebo in adults with primary ITP (platelets count <30 G/L) who require first-line standard-of-care corticosteroids. After completion of the screening period, the participants will enter the randomized treatment period (ianalumab/placebo with standard of care corticosteroids). After the treatment period, all participants will enter the follow-up period to be monitored for efficacy and safety or safety only depending on how they respond to the study treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Immune Thrombocytopenia (ITP)
Keywords
Primary immune thrombocytopenia (ITP), ianalumab, VAY736, B-cell depletion, B-cell Activating Factor Receptor (BAFF-R) blockade

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
225 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ianalumab Lower dose
Arm Type
Experimental
Arm Description
Lower dose of ianalumab administered intravenously with corticosteroids oral or parental (if clinically justified)
Arm Title
Ianalumab Higher dose
Arm Type
Experimental
Arm Description
Higher dose of ianalumab administered intravenously with corticosteroids oral or parental (if clinically justified)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo administered intravenously with corticosteroids oral or parental (if clinically justified)
Intervention Type
Biological
Intervention Name(s)
Ianalumab
Other Intervention Name(s)
VAY736
Intervention Description
Intravenously infusion, prepared from concentrate solution
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Intravenously infusion, prepared from matching placebo
Intervention Type
Drug
Intervention Name(s)
Corticosteroids
Intervention Description
Oral or parental (if clinically justified)
Primary Outcome Measure Information:
Title
Time from randomization to treatment failure (TTF)
Description
Time from randomization until platelet count below 30 G/L, need for a rescue treatment or start of a second-line therapy or death.
Time Frame
Randomization to end of study (up to 39 months after randomization of last patient)
Secondary Outcome Measure Information:
Title
Complete Response (CR) rate in each treatment group
Description
Complete Response (CR) rate at each timepoint defined as the proportion of participants with any platelet count of at least 100 G/L in the absence of rescue treatment or new ITP treatment.
Time Frame
Randomization to end of study (up to 39 months after randomization of last patient)
Title
Response (R) rate in each treatment group
Description
Response (R) rate at each timepoint defined as the proportion of participants with any platelet count of at least 50 G/L in the absence of rescue treatment or new ITP treatment.
Time Frame
Randomization to end of study (up to 39 months after randomization of last patient)
Title
Time to complete response in each treatment group
Description
Time from randomization to date of first complete response.
Time Frame
Randomization to end of study (up to 39 months after randomization of last patient)
Title
Duration of response in each treatment group
Description
Time from achievement of complete response to loss of complete response
Time Frame
Randomization to end of study (up to 39 months after randomization of last patient)
Title
Stable response at 6 months
Description
Percentage of participants with at least 2 platelet count collected at month 6 (between study dates 107 and 183) and at least 66% of platelet counts qualified as a response
Time Frame
At 6 months
Title
Stable response at 1 year
Description
Percentage of participants with at least 2 platelet counts collected at year 1 (between study days 296 and 379) and at least 66% of platelet counts qualified as a response
Time Frame
At 1 year
Title
Percentage of participants with bleeding events overall and by World Health Organization (WHO) bleeding scale severity
Description
This is to assess the incidence and severity of bleeding in each treatment arm
Time Frame
Randomization to end of study (up to 39 months after randomization of last patient)
Title
Number of participants with bleeding events overall and by World Health Organization (WHO) bleeding scale severity
Description
This is to assess the number and severity of bleeding in each treatment arm
Time Frame
Randomization to end of study (up to 39 months after randomization of last patient)
Title
Number of participants receiving rescue treatment (cummulative dose/duration of steroids exposure)
Description
This is to assess the number of participants receiving rescue treatment.
Time Frame
Randomization to end of study (up to 39 months after randomization of last patient)
Title
Percentage of participants receiving rescue treatment (cummulative dose/duration of steroids exposure)
Description
This is to assess the need of rescue treatment in each treatment group by percentage.
Time Frame
Randomization to end of study (up to 39 months after randomization of last patient)
Title
Cumulative dose/duration of steroids exposure
Description
Duration of exposure to corticosteroids calculated from randomization (first dose) to end of study or last last contact date (if the participant is lost to follow-up).
Time Frame
From screening to end of study (up to 39 months after randomization of last patient)
Title
Change from baseline on total scores of the PROMIS SF v1.0 Fatigue 13a
Description
The Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 Fatigue 13a includes 13 items that assess fatigue
Time Frame
From screening (baseline) till end of study (up to 39 months after randomization of last patient)
Title
Change from baseline in ITP-PAQ domain scores
Description
The ITP-PAQ is a 44 item scale for measuring HRQoL in adults with ITP across ten scales: Symptoms, Bother-Physical Health, Fatigue/Sleep, Activity, Fear, Psychological Health, Work, Social Activity, Women's Reproductive Health, and Overall QoL. Each item is rated on a Likert type scale
Time Frame
From screening (baseline) till end of study (up to 39 months after randomization of last patient)
Title
Change from baseline in frequency of CD19+ B cell counts
Description
Post baseline frequency (%within the CD45) of CD19+ B cell counts compare to baseline.
Time Frame
Randomization to end of study (up to 39 months after randomization of last patient)
Title
Change from baseline in absolute number of CD19+ B cell counts
Description
Post baseline absolute number of CD19+ B cell counts compare with baseline
Time Frame
Randomization to end of study (up to 39 months after randomization of last patient)
Title
Time to first occurrence of B-cell recovery
Description
B-cell recovery, defined as ≥80% of baseline or ≥50 cells/μL
Time Frame
Randomization to end of study (up to 39 months after randomized of last patient)
Title
Change from baseline in inmmunoglobulins
Description
Change from baseline in immunoglobulin levels
Time Frame
Randomization to end of study (up to 39 months after last randomized patients)
Title
PK parameters: AUClast
Description
AUClast: area under the curve from time zero till the last measurable concentration sampling time (tlast)
Time Frame
After first dose (pre-dose, 2, 168, 336 and 504 hours post dose) and after last dose (pre-dose, 2, 336, 672, 1344, 2016, 3360 hours post dose)
Title
PK parameter: AUCtau
Description
Area under the curve calculated to the end of a dosing interval (tau)
Time Frame
After first dose (pre-dose, 2, 168, 336 and 504 hours post dose) and after last dose (pre-dose, 2, 336, 672, 1344, 2016, 3360 hours post dose)
Title
PK parameters: Cmax
Description
Maximum (peak) observed plasma, blood, serum, or other body fluid drug concentration after single dose administration
Time Frame
After first dose (pre-dose, 2, 168, 336 and 504 hours post dose) and after last dose (pre-dose, 2, 336, 672, 1344, 2016, 3360 hours post dose)
Title
PK parameters: Tmax
Description
Time to reach maximum (peak) plasma, blood, serum, or other body fluid drug concentration
Time Frame
After first dose (pre-dose, 2, 168, 336 and 504 hours post dose) and after last dose (pre-dose, 2, 336, 672, 1344, 2016, 3360 hours post dose)
Title
PK parameters: Accumulation ratio Racc
Description
Accumulation ratio calculated using AUC values obtained between the last and first dose
Time Frame
After last dose (pre-dose, 2, 336, 672, 1344, 2016, 3360 hours post dose)
Title
Incidence of anti-ianalumab antibodies in serum (ADA assay) over time
Description
Anti-drug antibodies (ADA) will be evaluated in samples collected from all participants assess the immunogenicity of ianalumab
Time Frame
Up to Week 33
Title
Titer of anti-ianalumab antibodies in serum (ADA assay) over time
Description
Anti-drug antibodies (ADA) will be evaluated in samples collected from all participants assess the immunogenicity of ianalumab
Time Frame
Up to Week 33

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Signed informed consent prior to participation in the study. Male or female participants aged 18 years and older on the day of signing informed consent Primary ITP diagnosed within 3 months before initiating first-line ITP therapy (corticosteroids, IVIG) Platelet count below 30 G/L before starting any first-line ITP therapy (corticosteroids, IVIG) Response (platelet count >=50 G/L) to corticosteroids (+/- IVIG) at any time prior to randomization. Note: Platelet count measured within 7 days of platelet transfusion will not be considered as response. Key Exclusion Criteria: Evans syndrome or any other cytopenia Current life-threatening bleeding Previous ITP treatment, including splenectomy, except for corticosteroids and/or IVIG initiated as first-line therapy for up to 28 days before randomization and rescue corticosteroids and/or IVIG given prior to confirmed diagnosis of primary ITP . Prior use of B-cell depleting therapy (e.g., rituximab). Absolute neutrophil count below 1.0 G/L at randomization Participants with concurrent coagulation disorders and/or receiving anti-platelet or anticoagulant medication with an exemption of low dose of acetylsalicylic acid Other protocol-defined Inclusion/Exclusion may apply.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Novartis Pharmaceuticals
Phone
1-888-669-6682
Email
novartis.email@novartis.com
First Name & Middle Initial & Last Name or Official Title & Degree
Novartis Pharmaceuticals
Phone
+41613241111
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Napa Research
City
Margate
State/Province
Florida
ZIP/Postal Code
33063
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emilio Araujo-Mino
Facility Name
New Tampa Health
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Niubis Miranda
Email
miranda@newtampahealthresearch.com
First Name & Middle Initial & Last Name & Degree
Carlos Romero
Facility Name
Inspira Medical Cent Mullica Hill
City
Mullica Hill
State/Province
New Jersey
ZIP/Postal Code
08062
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catherine Vasquez
Phone
856-641-7526
Email
VasquezC@ihn.org
First Name & Middle Initial & Last Name & Degree
Erev Tubb
Facility Name
Hematology Oncology Association of Rockland
City
Nyack
State/Province
New York
ZIP/Postal Code
10960
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marion VanWoudenberg
Phone
845-362-1750
Email
research@highlandmedicalpc.com
First Name & Middle Initial & Last Name & Degree
Sung Ho Lee
Facility Name
Cleveland Clinic Foundation .
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
216-445-2572
First Name & Middle Initial & Last Name & Degree
Alan Lichtin
Facility Name
Community Cancer Trials of Utah
City
Ogden
State/Province
Utah
ZIP/Postal Code
84405
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sibian Torres
Phone
801-689-3909
Email
Sibian@communitycancertrials.com
First Name & Middle Initial & Last Name & Degree
Carl Gray
Facility Name
Novartis Investigative Site
City
Canberra
State/Province
Australian Capital Territory
ZIP/Postal Code
2605
Country
Australia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Wooloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Prahran
State/Province
Victoria
ZIP/Postal Code
3181
Country
Australia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Wien
ZIP/Postal Code
1140
Country
Austria
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Sofia
ZIP/Postal Code
1413
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Varna
ZIP/Postal Code
9010
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518037
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450052
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Xian
State/Province
Shaanxi
ZIP/Postal Code
710004
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
030001
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300020
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310006
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Dalian
ZIP/Postal Code
116000
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Jinan
ZIP/Postal Code
250012
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Brno Bohunice
State/Province
Czech Republic
ZIP/Postal Code
625 00
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Ostrava
State/Province
Poruba
ZIP/Postal Code
708 52
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Praha 10
ZIP/Postal Code
100 34
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Praha
ZIP/Postal Code
12808
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Le Mans
State/Province
Cedex 09
ZIP/Postal Code
72037
Country
France
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Caen
State/Province
Cedex
ZIP/Postal Code
14033
Country
France
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Chambéry cedex
ZIP/Postal Code
73011
Country
France
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Lille Cedex
ZIP/Postal Code
59037
Country
France
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Paris
ZIP/Postal Code
75014
Country
France
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Rennes
ZIP/Postal Code
35043
Country
France
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Essen
ZIP/Postal Code
45147
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Giessen
ZIP/Postal Code
35392
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Greifswald
ZIP/Postal Code
17475
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Jena
ZIP/Postal Code
07740
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
New Territories
Country
Hong Kong
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Budapest
ZIP/Postal Code
1085
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Bologna
State/Province
BO
ZIP/Postal Code
40138
Country
Italy
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Firenze
State/Province
FI
ZIP/Postal Code
50134
Country
Italy
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Roma
State/Province
RM
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Trieste
State/Province
TS
ZIP/Postal Code
34129
Country
Italy
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Vicenza
State/Province
VI
ZIP/Postal Code
36100
Country
Italy
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Shibukawa-city
State/Province
Gunma
ZIP/Postal Code
377-0280
Country
Japan
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-8604
Country
Japan
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Matsumoto-city
State/Province
Nagano
ZIP/Postal Code
399-8701
Country
Japan
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Okayama city
State/Province
Okayama
ZIP/Postal Code
701-1192
Country
Japan
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Osaka-city
State/Province
Osaka
ZIP/Postal Code
543-8555
Country
Japan
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Fukuoka
ZIP/Postal Code
815-8555
Country
Japan
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Kuching
State/Province
Sarawak
ZIP/Postal Code
93586
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Johor Bahru
ZIP/Postal Code
80100
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Selangor
ZIP/Postal Code
68000
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Gralum
ZIP/Postal Code
1714
Country
Norway
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Bucharest
State/Province
District 2
ZIP/Postal Code
022328
Country
Romania
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Bucharest
ZIP/Postal Code
030171
Country
Romania
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Bucuresti
ZIP/Postal Code
013975
Country
Romania
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Singapore
ZIP/Postal Code
119228
Country
Singapore
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Singapore
ZIP/Postal Code
169608
Country
Singapore
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Singapore
ZIP/Postal Code
S308433
Country
Singapore
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Sevilla
State/Province
Andalucia
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Salamanca
State/Province
Castilla Y Leon
ZIP/Postal Code
37007
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Barcelona
State/Province
Catalunya
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Madrid
ZIP/Postal Code
28009
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Murcia
ZIP/Postal Code
30008
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Aydin
ZIP/Postal Code
09100
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Edirne
ZIP/Postal Code
22030
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Istanbul
ZIP/Postal Code
34214
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Samsun
ZIP/Postal Code
55139
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Truro
State/Province
Cornwall
ZIP/Postal Code
TR1 3LJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Birmingham
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Leeds
ZIP/Postal Code
LS1 3EX
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
London
ZIP/Postal Code
SW17 0QT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
London
ZIP/Postal Code
W12 0HS
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Nottingham
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
IPD Sharing URL
https://www.clinicalstudydatarequest.com

Learn more about this trial

Study of Ianalumab Versus Placebo in Addition to First-line Corticosteroids in Primary Immune Thrombocytopenia (ITP)

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