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

March 22, 2024 updated by: Novartis Pharmaceuticals

A Phase III, Randomized, Double-blind Study of Ianalumab (VAY736) Versus Placebo in Addition to First-line Corticosteroids in Primary Immune Thrombocytopenia (VAYHIT1)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

225

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Novartis Pharmaceuticals
  • Phone Number: +41613241111

Study Locations

  • Argentina
      • Buenos aires, Argentina, C1039AAC
        • Recruiting
        • Novartis Investigative Site
    • Buenos Aires
      • Caba, Buenos Aires, Argentina, C1280AEB
        • Recruiting
        • Novartis Investigative Site
      • Caba, Buenos Aires, Argentina, C1414DRK
        • Recruiting
        • Novartis Investigative Site
      • Ciudad Autonoma de Bs As, Buenos Aires, Argentina, C1015ABO
        • Recruiting
        • Novartis Investigative Site
    • San Miguel De Tucuman
      • Tucuman, San Miguel De Tucuman, Argentina, 4000
        • Recruiting
        • Novartis Investigative Site
  • Australia
    • Australian Capital Territory
      • Canberra, Australian Capital Territory, Australia, 2605
        • Recruiting
        • Novartis Investigative Site
    • Queensland
      • Wooloongabba, Queensland, Australia, 4102
        • Recruiting
        • Novartis Investigative Site
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Recruiting
        • Novartis Investigative Site
      • Prahran, Victoria, Australia, 3181
        • Recruiting
        • Novartis Investigative Site
  • Austria
      • Salzburg, Austria, 5020
        • Recruiting
        • Novartis Investigative Site
      • Wien, Austria, 1140
        • Recruiting
        • Novartis Investigative Site
    • Tyrol
      • Innsbruck, Tyrol, Austria, 6020
        • Recruiting
        • Novartis Investigative Site
  • Belgium
      • Brugge, Belgium, 8000
        • Recruiting
        • Novartis Investigative Site
      • Leuven, Belgium, 3000
        • Recruiting
        • Novartis Investigative Site
      • Roeselare, Belgium, 8800
        • Recruiting
        • Novartis Investigative Site
  • Bulgaria
      • Plovdiv, Bulgaria, 4002
        • Recruiting
        • Novartis Investigative Site
      • Sofia, Bulgaria, 1431
        • Recruiting
        • Novartis Investigative Site
      • Sofia, Bulgaria, 1413
        • Recruiting
        • Novartis Investigative Site
      • Varna, Bulgaria, 9010
        • Recruiting
        • Novartis Investigative Site
  • China
      • Beijing, China, 100044
        • Recruiting
        • Novartis Investigative Site
      • Dalian, China, 116000
        • Recruiting
        • Novartis Investigative Site
      • Jinan, China, 250012
        • Recruiting
        • Novartis Investigative Site
      • Tianjin, China, 300020
        • Recruiting
        • Novartis Investigative Site
    • Guangdong
      • Guangzhou, Guangdong, China, 510515
        • Recruiting
        • Novartis Investigative Site
      • Shenzhen, Guangdong, China, 518037
        • Recruiting
        • Novartis Investigative Site
    • Henan
      • Zhengzhou, Henan, China, 450052
        • Recruiting
        • Novartis Investigative Site
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Recruiting
        • Novartis Investigative Site
    • Hunan
      • Changsha, Hunan, China, 410008
        • Recruiting
        • Novartis Investigative Site
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • Recruiting
        • Novartis Investigative Site
    • Shaanxi
      • Xian, Shaanxi, China, 710004
        • Recruiting
        • Novartis Investigative Site
    • Shanxi
      • Taiyuan, Shanxi, China, 030001
        • Recruiting
        • Novartis Investigative Site
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Recruiting
        • Novartis Investigative Site
    • Yunnan
      • Kunming, Yunnan, China, 650101
        • Recruiting
        • Novartis Investigative Site
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310006
        • Recruiting
        • Novartis Investigative Site
      • Hangzhou, Zhejiang, China, 310003
        • Recruiting
        • Novartis Investigative Site
  • Czechia
      • Praha, Czechia, 12808
        • Recruiting
        • Novartis Investigative Site
      • Praha 10, Czechia, 100 34
        • Recruiting
        • Novartis Investigative Site
    • Czech Republic
      • Brno Bohunice, Czech Republic, Czechia, 625 00
        • Recruiting
        • Novartis Investigative Site
    • Poruba
      • Ostrava, Poruba, Czechia, 708 52
        • Recruiting
        • Novartis Investigative Site
  • France
      • Chambéry cedex, France, 73011
        • Recruiting
        • Novartis Investigative Site
      • Lille, France, 59037
        • Recruiting
        • Novartis Investigative Site
      • Paris, France, 75014
        • Recruiting
        • Novartis Investigative Site
      • Rennes, France, 35043
        • Recruiting
        • Novartis Investigative Site
    • Cedex
      • Caen, Cedex, France, 14033
        • Recruiting
        • Novartis Investigative Site
    • Cedex 09
      • Le Mans, Cedex 09, France, 72037
        • Recruiting
        • Novartis Investigative Site
  • Germany
      • Dresden, Germany, 01307
        • Recruiting
        • Novartis Investigative Site
      • Essen, Germany, 45147
        • Recruiting
        • Novartis Investigative Site
      • Frankfurt, Germany, 60590
        • Recruiting
        • Novartis Investigative Site
      • Giessen, Germany, 35392
        • Recruiting
        • Novartis Investigative Site
      • Greifswald, Germany, 17475
        • Recruiting
        • Novartis Investigative Site
      • Hannover, Germany, 30161
        • Recruiting
        • Novartis Investigative Site
      • Jena, Germany, 07740
        • Recruiting
        • Novartis Investigative Site
  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • Novartis Investigative Site
      • New Territories, Hong Kong
        • Recruiting
        • Novartis Investigative Site
  • Hungary
      • Budapest, Hungary, 1085
        • Recruiting
        • Novartis Investigative Site
      • Debrecen, Hungary, 4032
        • Recruiting
        • Novartis Investigative Site
  • India
    • West Bengal
      • Kolkata, West Bengal, India, 700094
        • Recruiting
        • Novartis Investigative Site
  • Italy
    • BO
      • Bologna, BO, Italy, 40138
        • Recruiting
        • Novartis Investigative Site
    • FI
      • Firenze, FI, Italy, 50134
        • Recruiting
        • Novartis Investigative Site
    • RM
      • Roma, RM, Italy, 00168
        • Recruiting
        • Novartis Investigative Site
    • TS
      • Trieste, TS, Italy, 34129
        • Recruiting
        • Novartis Investigative Site
    • VI
      • Vicenza, VI, Italy, 36100
        • Recruiting
        • Novartis Investigative Site
  • Japan
      • Chiba, Japan, 260-0852
        • Recruiting
        • Novartis Investigative Site
      • Fukuoka, Japan, 815-8555
        • Recruiting
        • Novartis Investigative Site
    • Gifu
      • Gifu shi, Gifu, Japan, 500 8513
        • Recruiting
        • Novartis Investigative Site
    • Gunma
      • Shibukawa-city, Gunma, Japan, 377-0280
        • Recruiting
        • Novartis Investigative Site
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-8604
        • Recruiting
        • Novartis Investigative Site
    • Nagano
      • Matsumoto-city, Nagano, Japan, 399-8701
        • Recruiting
        • Novartis Investigative Site
    • Okayama
      • Okayama city, Okayama, Japan, 701-1192
        • Recruiting
        • Novartis Investigative Site
    • Osaka
      • Osaka-city, Osaka, Japan, 543-8555
        • Recruiting
        • Novartis Investigative Site
    • Saitama
      • Iruma-gun, Saitama, Japan, 350-0495
        • Recruiting
        • Novartis Investigative Site
  • Malaysia
      • Johor Bahru, Malaysia, 80100
        • Recruiting
        • Novartis Investigative Site
      • Penang, Malaysia, 10050
        • Recruiting
        • Novartis Investigative Site
      • Selangor, Malaysia, 68000
        • Recruiting
        • Novartis Investigative Site
    • MYS
      • Kuala Lumpur, MYS, Malaysia, 56000
        • Recruiting
        • Novartis Investigative Site
    • Sarawak
      • Kuching, Sarawak, Malaysia, 93586
        • Recruiting
        • Novartis Investigative Site
  • Mexico
    • Mexico CP
      • Ciudad de Mexico, Mexico CP, Mexico, 14080
        • Recruiting
        • Novartis Investigative Site
    • Michoacan
      • Morelia, Michoacan, Mexico, 58260
        • Recruiting
        • Novartis Investigative Site
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico, 64460
        • Recruiting
        • Novartis Investigative Site
  • Norway
      • Gralum, Norway, 1714
        • Recruiting
        • Novartis Investigative Site
  • Romania
      • Bucharest, Romania, 030171
        • Recruiting
        • Novartis Investigative Site
      • Bucuresti, Romania, 013975
        • Recruiting
        • Novartis Investigative Site
    • District 2
      • Bucharest, District 2, Romania, 022328
        • Recruiting
        • Novartis Investigative Site
  • Singapore
      • Singapore, Singapore, 119228
        • Recruiting
        • Novartis Investigative Site
      • Singapore, Singapore, 169608
        • Recruiting
        • Novartis Investigative Site
      • Singapore, Singapore, S308433
        • Recruiting
        • Novartis Investigative Site
  • Spain
      • Madrid, Spain, 28046
        • Recruiting
        • Novartis Investigative Site
      • Madrid, Spain, 28009
        • Recruiting
        • Novartis Investigative Site
      • Murcia, Spain, 30008
        • Recruiting
        • Novartis Investigative Site
    • Andalucia
      • Sevilla, Andalucia, Spain, 41013
        • Recruiting
        • Novartis Investigative Site
    • Castilla Y Leon
      • Salamanca, Castilla Y Leon, Spain, 37007
        • Recruiting
        • Novartis Investigative Site
    • Catalunya
      • Barcelona, Catalunya, Spain, 08035
        • Recruiting
        • Novartis Investigative Site
  • Thailand
      • Bangkok, Thailand, 10330
        • Recruiting
        • Novartis Investigative Site
      • Bangkok, Thailand, 10700
        • Recruiting
        • Novartis Investigative Site
      • Chiang Mai, Thailand, 50200
        • Recruiting
        • Novartis Investigative Site
  • Turkey
      • Aydin, Turkey, 09100
        • Recruiting
        • Novartis Investigative Site
      • Edirne, Turkey, 22030
        • Recruiting
        • Novartis Investigative Site
      • Istanbul, Turkey, 34214
        • Recruiting
        • Novartis Investigative Site
      • Izmir, Turkey, 35040
        • Recruiting
        • Novartis Investigative Site
      • Samsun, Turkey, 55139
        • Recruiting
        • Novartis Investigative Site
    • TUR
      • Istanbul, TUR, Turkey, 34098
        • Recruiting
        • Novartis Investigative Site
  • United Kingdom
      • Birmingham, United Kingdom, B15 2TH
        • Recruiting
        • Novartis Investigative Site
      • Glasgow, United Kingdom, G31 2ER
        • Recruiting
        • Novartis Investigative Site
      • Leeds, United Kingdom, LS1 3EX
        • Recruiting
        • Novartis Investigative Site
      • London, United Kingdom, SW17 0QT
        • Recruiting
        • Novartis Investigative Site
      • London, United Kingdom, W12 0HS
        • Recruiting
        • Novartis Investigative Site
      • Nottingham, United Kingdom, NG5 1PB
        • Recruiting
        • Novartis Investigative Site
    • Cornwall
      • Truro, Cornwall, United Kingdom, TR1 3LJ
        • Recruiting
        • Novartis Investigative Site
  • United States
    • Arizona
      • Yuma, Arizona, United States, 85349
        • Recruiting
        • Yuma Regional Medical Center
        • Principal Investigator:
          • Abhinav Chandra
        • Contact:
    • California
      • Clovis, California, United States, 93611
        • Recruiting
        • Community Cancer Institute
        • Principal Investigator:
          • Mohammed Bukari
        • Contact:
      • Fountain Valley, California, United States, 92708
        • Recruiting
        • Compassionate Care Res Group Inc
        • Principal Investigator:
          • Eric Lee
        • Contact:
          • Phone Number: 714-210-2300
    • Florida
      • Margate, Florida, United States, 33063
        • Recruiting
        • Napa Research
        • Principal Investigator:
          • Emilio Araujo-Mino
      • Tampa, Florida, United States, 33603
        • Withdrawn
        • New Tampa Health
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • Uni of Chi Medi Ctr Hema and Onco Main Centre
        • Contact:
        • Principal Investigator:
          • Michael Drazer
    • Maryland
      • Bethesda, Maryland, United States, 20817
        • Recruiting
        • Oncology Care Associates
        • Principal Investigator:
          • Ralph V Boccia
        • Contact:
    • Minnesota
      • Saint Louis Park, Minnesota, United States, 55416
        • Recruiting
        • Metro Minnesota CCOP Main Site Address Oncology
        • Principal Investigator:
          • Yan Ji
    • Montana
      • Billings, Montana, United States, 59102
        • Recruiting
        • St Vincent Frontier Cancer Center .
        • Principal Investigator:
          • Patrick Cobb
        • Contact:
    • New Jersey
      • Mullica Hill, New Jersey, United States, 08062
        • Recruiting
        • Inspira Medical Cent Mullica Hill
        • Contact:
        • Principal Investigator:
          • Erev Tubb
    • New York
      • Lake Success, New York, United States, 11042
        • Recruiting
        • Clinical Research Alliance Research
        • Principal Investigator:
          • James D Olimpio
        • Contact:
      • Nyack, New York, United States, 10960
        • Recruiting
        • Hematology Oncology Association of Rockland
        • Contact:
        • Principal Investigator:
          • Sung Ho Lee
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic Foundation .
        • Principal Investigator:
          • Alan Lichtin
        • Contact:
      • Dayton, Ohio, United States, 45402
        • Recruiting
        • STAT Research Inc Premier Clin Res LLC STAT Res
        • Principal Investigator:
          • Charles Bane
        • Contact:
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73142
        • Recruiting
        • INTEGRIS Cancer Institute of Oklahoma Integris South West Med Center
        • Contact:
        • Principal Investigator:
          • Basgar Alasad
    • Texas
      • Dallas, Texas, United States, 75204
        • Recruiting
        • Texas Oncology-Baylor Res Ins
        • Principal Investigator:
          • Moshe Yair Levy
        • Contact:
          • Phone Number: +1 214 820 2687
      • McAllen, Texas, United States, 78503
    • Utah
      • Ogden, Utah, United States, 84405
        • Recruiting
        • Community Cancer Trials of Utah
        • Contact:
        • Principal Investigator:
          • Carl Gray
  • Vietnam
      • Hanoi, Vietnam, 100000
        • Recruiting
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 (patients with anemia related to bleeding or iron deficiency are eligible)
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ianalumab Lower dose
Lower dose of ianalumab administered intravenously with corticosteroids oral or parental (if clinically justified)
Biological: Ianalumab
Intravenous infusion, prepared from concentrate solution
Other Names:
  • VAY736
Drug: Corticosteroids
Oral or parental (if clinically justified)
Experimental: Ianalumab Higher dose
Higher dose of ianalumab administered intravenously with corticosteroids oral or parental (if clinically justified)
Biological: Ianalumab
Intravenous infusion, prepared from concentrate solution
Other Names:
  • VAY736
Drug: Corticosteroids
Oral or parental (if clinically justified)
Placebo Comparator: Placebo
Placebo administered intravenously with corticosteroids oral or parental (if clinically justified)
Drug: Corticosteroids
Oral or parental (if clinically justified)
Drug: Placebo
Intravenous infusion, prepared from matching placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time from randomization to treatment failure (TTF)
Time Frame: Randomization to end of study (up to 39 months after randomization of last patient)
Time from randomization until platelet count below 30 G/L, need for a rescue treatment or start of a second-line therapy or death.
Randomization to end of study (up to 39 months after randomization of last patient)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete Response (CR) rate in each treatment group
Time Frame: Randomization to end of study (up to 39 months after randomization of last patient)
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.
Randomization to end of study (up to 39 months after randomization of last patient)
Response (R) rate in each treatment group
Time Frame: Randomization to end of study (up to 39 months after randomization of last patient)
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.
Randomization to end of study (up to 39 months after randomization of last patient)
Time to complete response in each treatment group
Time Frame: Randomization to end of study (up to 39 months after randomization of last patient)
Time from randomization to date of first complete response.
Randomization to end of study (up to 39 months after randomization of last patient)
Duration of response in each treatment group
Time Frame: Randomization to end of study (up to 39 months after randomization of last patient)
Time from achievement of complete response to loss of complete response
Randomization to end of study (up to 39 months after randomization of last patient)
Percentage of participants with bleeding events overall and by World Health Organization (WHO) bleeding scale severity
Time Frame: Randomization to end of study (up to 39 months after randomization of last patient)
This is to assess the incidence and severity of bleeding in each treatment arm
Randomization to end of study (up to 39 months after randomization of last patient)
Number of participants with bleeding events overall and by World Health Organization (WHO) bleeding scale severity
Time Frame: Randomization to end of study (up to 39 months after randomization of last patient)
This is to assess the number and severity of bleeding in each treatment arm
Randomization to end of study (up to 39 months after randomization of last patient)
Number of participants receiving rescue treatment (cummulative dose/duration of steroids exposure)
Time Frame: Randomization to end of study (up to 39 months after randomization of last patient)
This is to assess the number of participants receiving rescue treatment.
Randomization to end of study (up to 39 months after randomization of last patient)
Percentage of participants receiving rescue treatment (cummulative dose/duration of steroids exposure)
Time Frame: Randomization to end of study (up to 39 months after randomization of last patient)
This is to assess the need of rescue treatment in each treatment group by percentage.
Randomization to end of study (up to 39 months after randomization of last patient)
Cumulative dose/duration of steroids exposure
Time Frame: From screening to end of study (up to 39 months after randomization of last patient)
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).
From screening to end of study (up to 39 months after randomization of last patient)
Change from baseline in ITP-PAQ domain scores
Time Frame: From screening (baseline) till end of study (up to 39 months after randomization of last patient)
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
From screening (baseline) till end of study (up to 39 months after randomization of last patient)
Change from baseline in frequency of CD19+ B cell counts
Time Frame: Randomization to end of study (up to 39 months after randomization of last patient)
Post baseline frequency (%within the CD45) of CD19+ B cell counts compare to baseline.
Randomization to end of study (up to 39 months after randomization of last patient)
Change from baseline in absolute number of CD19+ B cell counts
Time Frame: Randomization to end of study (up to 39 months after randomization of last patient)
Post baseline absolute number of CD19+ B cell counts compare with baseline
Randomization to end of study (up to 39 months after randomization of last patient)
Time to first occurrence of B-cell recovery
Time Frame: Randomization to end of study (up to 39 months after randomized of last patient)
B-cell recovery, defined as ≥80% of baseline or ≥50 cells/μL
Randomization to end of study (up to 39 months after randomized of last patient)
Change from baseline in inmmunoglobulins
Time Frame: Randomization to end of study (up to 39 months after last randomized patients)
Change from baseline in immunoglobulin levels
Randomization to end of study (up to 39 months after last randomized patients)
PK parameters: AUClast
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)
AUClast: area under the curve from time zero till the last measurable concentration sampling time (tlast)
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)
PK parameter: AUCtau
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)
Area under the curve calculated to the end of a dosing interval (tau)
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)
PK parameters: Cmax
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)
Maximum (peak) observed plasma, blood, serum, or other body fluid drug concentration after single dose administration
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)
PK parameters: Tmax
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)
Time to reach maximum (peak) plasma, blood, serum, or other body fluid drug concentration
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)
PK parameters: Accumulation ratio Racc
Time Frame: After last dose (pre-dose, 2, 336, 672, 1344, 2016, 3360 hours post dose)
Accumulation ratio calculated using AUC values obtained between the last and first dose
After last dose (pre-dose, 2, 336, 672, 1344, 2016, 3360 hours post dose)
Incidence of anti-ianalumab antibodies in serum (ADA assay) over time
Time Frame: Up to Week 33
Anti-drug antibodies (ADA) will be evaluated in samples collected from all participants assess the immunogenicity of ianalumab
Up to Week 33
Titer of anti-ianalumab antibodies in serum (ADA assay) over time
Time Frame: Up to Week 33
Anti-drug antibodies (ADA) will be evaluated in samples collected from all participants assess the immunogenicity of ianalumab
Up to Week 33
Stable response at 6 months
Time Frame: 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
At 6 months
Stable response at 1 year
Time Frame: 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
At 1 year
Change from baseline on T scores of the PROMIS SF v1.0 Fatigue 13a
Time Frame: From screening (baseline) till end of study (up to 39 months after randomization of last patient)
The Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 Fatigue 13a includes 13 items that assess fatigue
From screening (baseline) till end of study (up to 39 months after randomization of last patient)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Investigators

  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 6, 2023

Primary Completion (Estimated)

September 25, 2025

Study Completion (Estimated)

February 4, 2028

Study Registration Dates

First Submitted

November 23, 2022

First Submitted That Met QC Criteria

December 14, 2022

First Posted (Actual)

December 16, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2024

Last Update Submitted That Met QC Criteria

March 22, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CVAY736I12301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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