Étude comparant Ianalumab à un placebo en plus des corticostéroïdes de première intention dans la thrombocytopénie immunitaire primaire (PTI) (VAYHIT1)
Une étude de phase III, randomisée, en double aveugle comparant Ianalumab (VAY736) à un placebo en plus des corticostéroïdes de première intention dans la thrombocytopénie immunitaire primaire (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 increasing the rate of stable response off treatment at 12 months (SROT-12) in adult participants with primary ITP.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
The efficacy and safety follow-up period will last until treatment failure or up to 39 months after randomization of the last patient, whichever occurs first. Safety follow-up period will be performed for at least 20 weeks and up to 2 years after the last ianalumab/placebo dose.
The primary endpoint was updated in May 2026 to stable response off treatment at 12 months (SROT-12). The previous primary endpoint, time to treatment failure (TTF), remains in the study as a key secondary objective.
Type d'étude
Inscription (Réel)
Phase
- Phase 3
Contacts et emplacements
Lieux d'étude
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Dresden, Allemagne, 01307
- Novartis Investigative Site
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Hesse
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Frankfurt am Main, Hesse, Allemagne, 60590
- Novartis Investigative Site
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Saxony
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Dresden, Saxony, Allemagne, 01307
- Novartis Investigative Site
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Thuringia
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Jena, Thuringia, Allemagne, 07740
- Novartis Investigative Site
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Buenos Aires, Argentine, C1039AAC
- Novartis Investigative Site
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Córdoba, Argentine, 5000
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Buenos Aires
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CABA, Buenos Aires, Argentine, C1414DRK
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CABA, Buenos Aires, Argentine, C1280AEB
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Tucumán Province
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San Miguel Tucuman, Tucumán Province, Argentine, T4000DPK
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Australian Capital Territory
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Garran, Australian Capital Territory, Australie, 2605
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Queensland
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Wooloongabba, Queensland, Australie, 4102
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Victoria
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Clayton, Victoria, Australie, 3168
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Brasschaat, Belgique, 2930
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Bruges, Belgique, 8000
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West Vlaanderen
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Roeselare, West Vlaanderen, Belgique, 8800
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Plovdiv, Bulgarie, 4002
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Sofia, Bulgarie, 1431
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Bengbu, Chine, 233004
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Dalian, Chine, 116000
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Tianjin, Chine, 300020
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Beijing Municipality
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Beijing, Beijing Municipality, Chine, 100044
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Guangdong
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Guangzhou, Guangdong, Chine, 510515
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Shenzhen, Guangdong, Chine, 518037
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Hebei
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Shijiazhuang, Hebei, Chine, 050000
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Henan
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Luoyang, Henan, Chine, 471003
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Zhengzhou, Henan, Chine, 450003
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Jiangsu
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Changzhou, Jiangsu, Chine, 213004
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Jiangxi
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Nanchang, Jiangxi, Chine, 330006
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Yunnan
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Kunming, Yunnan, Chine, 650101
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Zhejiang
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Hangzhou, Zhejiang, Chine, 310006
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Barcelona, Espagne, 08035
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Madrid, Espagne, 28009
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Murcia, Espagne, 30008
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Seville, Espagne, 41013
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Caen, France, 14033
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Chambéry, France, 73000
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Le Mans, France, 72000
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Lille, France, 59037
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Rennes, France, 35033
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Hong Kong, Hong Kong, 999077
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Hong Kong
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New Territories, Hong Kong, Hong Kong, 999077
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Budapest, Hongrie, 1083
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Hajdu Bihar Megye
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Debrecen, Hajdu Bihar Megye, Hongrie, 4032
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Gujarat
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Ahmedabad, Gujarat, Inde, 380013
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Uttarakhand
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Rishikesh, Uttarakhand, Inde, 249203
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BO
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Bologna, BO, Italie, 40138
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FI
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Florence, FI, Italie, 50134
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RM
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Roma, RM, Italie, 00168
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TS
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Trieste, TS, Italie, 34129
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VI
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Vicenza, VI, Italie, 36100
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Chiba, Japon, 2600852
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Fukuoka, Japon, 8158555
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Gifu, Japon, 5008513
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Osaka, Japon, 5438555
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Aichi-ken
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Nagakute, Aichi-ken, Japon, 4801195
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Gunma
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Shibukawa, Gunma, Japon, 3770280
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Hokkaido
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Sapporo, Hokkaido, Japon, 0608604
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Okayama-ken
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Okayama, Okayama-ken, Japon, 7011192
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Saitama
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Iruma-gun, Saitama, Japon, 3500495
- Novartis Investigative Site
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Salzburg, L'Autriche, 5020
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Tyrol
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Innsbruck, Tyrol, L'Autriche, 6020
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George Town, Malaisie, 10050
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Johor Bahru, Malaisie, 80100
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Kuala Selangor, Malaisie, 68000
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Sarawak
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Kuching, Sarawak, Malaisie, 93586
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Mexico City
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Mexico City, Mexico City, Mexique, 06720
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Nuevo León
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Monterrey, Nuevo León, Mexique, 64460
- Novartis Investigative Site
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Grålum, Norvège, 1714
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Bucharest, Roumanie, 030171
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London, Royaume-Uni, W12 0HS
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Nottingham, Royaume-Uni, NG5 1PB
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West Midlands
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Birmingham, West Midlands, Royaume-Uni, B15 2TH
- Novartis Investigative Site
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Singapore, Singapour, 119074
- Novartis Investigative Site
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Singapore, Singapour, 169608
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Prague, Tchéquie, 128 08
- Novartis Investigative Site
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Prague, Tchéquie, 100 34
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Poruba
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Ostrava, Poruba, Tchéquie, 708 52
- Novartis Investigative Site
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Bangkok, Thaïlande, 10330
- Novartis Investigative Site
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Bangkok, Thaïlande, 10700
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Chiang Mai, Thaïlande, 50200
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Atakum
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Samsun, Atakum, Turquie (Türkiye), 55200
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Efeler
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Aydin, Efeler, Turquie (Türkiye), 09100
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Fatih
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Istanbul, Fatih, Turquie (Türkiye), 34098
- Novartis Investigative Site
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Hanoi, Viêt Nam, 100000
- Novartis Investigative Site
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Ho Chi Minh City, Viêt Nam, 70000
- Novartis Investigative Site
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Arizona
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Yuma, Arizona, États-Unis, 85364
- Yuma Regional Medical Center
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California
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Clovis, California, États-Unis, 93611
- Community Cancer Institute
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Fountain Valley, California, États-Unis, 92708
- Compassionate Care Res Group Inc
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Colorado
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Aurora, Colorado, États-Unis, 80045
- University of Colorado Anschutz
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Florida
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Margate, Florida, États-Unis, 33063
- DH Cancer Research Center LLC
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Illinois
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Chicago, Illinois, États-Unis, 60637
- Uni of Chi Medi Ctr Hema and Onco
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Indiana
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Fort Wayne, Indiana, États-Unis, 46845
- Parkview Research Center
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Massachusetts
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Boston, Massachusetts, États-Unis, 02114
- Massachusetts General Hospital
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Boston, Massachusetts, États-Unis, 02215
- Beth Israel Deaconess Med Center
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Minnesota
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Rochester, Minnesota, États-Unis, 55905
- Mayo Clinic Rochester
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New York
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Nyack, New York, États-Unis, 10960
- Hematology Oncology Association of Rockland
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Rhode Island
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Providence, Rhode Island, États-Unis, 02903
- Rhode Island Hospital
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Texas
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San Antonio, Texas, États-Unis, 78229
- Mays Cancer Ctr Uthsa Mdacc
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Utah
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Ogden, Utah, États-Unis, 84405
- Community Cancer Trials of Utah
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La 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 low grade 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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Ianalumab Lower dose
Lower dose of ianalumab administered intravenously with corticosteroids oral or parental (if clinically justified) |
Intravenous infusion, prepared from concentrate solution
Autres noms:
Oral or parental (if clinically justified) |
|
Expérimental: Ianalumab Higher dose
Higher dose of ianalumab administered intravenously with corticosteroids oral or parental (if clinically justified) |
Intravenous infusion, prepared from concentrate solution
Autres noms:
Oral or parental (if clinically justified) |
|
Comparateur placebo: Placebo
Placebo administered intravenously with corticosteroids oral or parental (if clinically justified) |
Oral or parental (if clinically justified) Intravenous infusion, prepared from matching placebo |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Rate of Stable Response off treatment at 12 months (SROT-12)
Délai: 12 months after last patient completed treatment
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A participant will be considered in SROT-12 if at least 75% of the platelet counts collected between visits Week 53 Day 1 and Week 65 Day 1 (Study Days 352 and 463) qualify as Response. Response is any platelet counts of at least 50 G/L in the absence of rescue treatment or new immune thrombocytopenia (ITP) treatment). |
12 months after last patient completed treatment
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Time from randomization to Treatment Failure (TTF) (Key Secondary Endpoint)
Délai: Randomization to end of study (up to 39 months after randomization of last patient
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Time to Treatment Failure (TTF) is defined as the time from randomization until the first of the following events/situation indicative of treatment failure: platelet count below 30 G/L later than 8 weeks from randomization, need for a rescue treatment later than 8 weeks from randomization, intake of rescue treatment (e.g., corticosteroids, Intravenous immunoglobulins (IVIG), or platelet transfusion) given later than 8 weeks from randomization, start of new Immune Thrombocytopenia (ITP) treatment whenever it occurs, death (whatever the cause). |
Randomization to end of study (up to 39 months after randomization of last patient
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Complete Response (CR) rate in each treatment group
Délai: Randomization to end of study (up to 39 months after randomization of last patient)
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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)
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Response (R) rate in each treatment group
Délai: Randomization to end of study (up to 39 months after randomization of last patient)
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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)
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Time to complete response in each treatment group
Délai: Randomization to end of study (up to 39 months after randomization of last patient)
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Time from randomization to date of first complete response. |
Randomization to end of study (up to 39 months after randomization of last patient)
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Duration of response in each treatment group
Délai: Randomization to end of study (up to 39 months after randomization of last patient)
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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)
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Stable response at 6 months
Délai: At 6 months
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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
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Stable response at 1 year
Délai: At 1 year
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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
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Percentage of participants with bleeding events overall and by World Health Organization (WHO) bleeding scale severity
Délai: 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)
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Number of participants with bleeding events overall and by World Health Organization (WHO) bleeding scale severity
Délai: Randomization to end of study (up to 39 months after randomization of last patient)
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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)
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Number of participants receiving rescue treatment (cummulative dose/duration of steroids exposure)
Délai: Randomization to end of study (up to 39 months after randomization of last patient)
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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)
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Percentage of participants receiving rescue treatment (cummulative dose/duration of steroids exposure)
Délai: Randomization to end of study (up to 39 months after randomization of last patient)
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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)
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Cumulative dose/duration of steroids exposure
Délai: From screening to end of study (up to 39 months after randomization of last patient)
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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)
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Change from baseline on T scores of the PROMIS SF v1.0 Fatigue 13a
Délai: From screening (baseline) till end of study (up to 39 months after randomization of last patient)
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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)
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Change from baseline in ITP-PAQ domain scores
Délai: 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
Délai: 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)
|
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Change from baseline in absolute number of CD19+ B cell counts
Délai: 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
Délai: Randomization to end of study (up to 39 months after randomized of last patient)
|
B-cell recovery is defined as ≥80% of baseline and ≥LLOQ, or ≥50 cells/μL |
Randomization to end of study (up to 39 months after randomized of last patient)
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|
Change from baseline in inmmunoglobulins
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Novartis Pharmaceuticals, Novartis Pharmaceuticals
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Cytopénie
- Processus pathologiques
- Maladies auto-immunes
- Maladies du système immunitaire
- Hémorragie
- Manifestations cutanées
- Maladies hématologiques
- Troubles de la coagulation sanguine
- Troubles hémorragiques
- Troubles des plaquettes sanguines
- Microangiopathies thrombotiques
- Purpura thrombocytopénique
- Purpura
- Thrombocytopénie
- Conditions pathologiques, signes et symptômes
- Signes et symptômes
- Maladies hémiques et lymphatiques
- Purpura, thrombocytopénique, idiopathique
- Hormones
- Hormones, substituts hormonaux et antagonistes hormonaux
- ianalumab
- Hormones cortex surrénaliques
Autres numéros d'identification d'étude
- CVAY736I12301
- 2024-511704-17-00 (Identificateur de registre: EU CTIS)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
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
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .