E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
Autoimmune condition of unknown cause where the body's own
self-defenses attack glands that secrete fluids resulting in inflammation
of the glands. The inflammatory process can involve other organs. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Immune System Diseases [C20] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10040767 |
E.1.2 | Term | Sjogren's syndrome |
E.1.2 | System Organ Class | 10028395 - Musculoskeletal and connective tissue disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the safety and tolerability of iscalimab in patients with Sjogren's, who participated in the TWINSS core study, CCFZ533B2201 |
Evaluer la sécurité d’emploi et la tolérance de 2 doses d'iscalimab (600 mg et 300 mg) chez des patients atteints de syndrome de Sjögren, qui ont participé à l’étude principale TWINSS, CCFZ533B2201 |
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E.2.2 | Secondary objectives of the trial |
To assess the pharmacokinetics (PK trough levels) and dose-exposure relationship of iscalimab;
To assess immunogenicity of iscalimab |
Evaluer la pharmacocinétique (concentrations résiduelles) et la relation dose-exposition de l'iscalimab
Evaluer l'immunogénicité de l’iscalimab |
|
E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Digital assessments: wearable sensor, cognitive and mood assessments (2020-07-07, Version 00).
Digital assessments will be performed to assess the efficacy of iscalimab in improving fatigue, cognitive and mood status digitally measured with wearable device or smartphone/tablet applications (optional assessments conducted at selected sites) |
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E.3 | Principal inclusion criteria |
Participants eligible for inclusion in this study must meet all of the following criteria:
1. Participants must have participated in the TWINSS core study, CCFZ533B2201, and must have completed the entire treatment period up to Week 48 and the follow-up period up to Week 60
2. Signed informed consent must be obtained prior to participation in the extension study (i.e. before commencement of the Week 60 assessments of the core study)
3. In the judgement of the Investigator, participants must be expected to clinically benefit from continued iscalimab therapy |
Pour l’inclusion dans l’étude, les patients doivent être affiliés à un régime de sécurité sociale (y compris la Couverture Médicale Universelle – CMU) ou être bénéficiaires d’un tel régime, et doivent remplir tous les critères suivants :
1°: Les patients doivent avoir participé à l’étude principale TWINSS, CCFZ533B2201, et doivent avoir terminé la période de traitement jusqu’à la semaine 48 et la période de suivi jusqu’à la semaine 60
2°: Formulaire de consentement éclairé signé obtenu avant l’inclusion du patient dans l’étude d'extension (c.-à-d., avant de commencer les évaluations de la semaine 60 de l’étude principale)
3°: Selon l’avis de l’investigateur, les patients doivent être susceptibles de bénéficier, sur le plan clinique, d’un traitement continu par iscalimab. |
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E.4 | Principal exclusion criteria |
Participants meeting any of the following criteria are not eligible for inclusion in this study.
1. Sjögren’s Syndrome overlap syndromes where another autoimmune rheumatic disease constitutes the principle illness, specifically:
- Moderate-to-severe active systemic lupus erythematosus (SLE) with anti-dsDNA positivity and renal involvement, or other organ involvement that impedes on ability to score ESSDAI domains
- Active rheumatoid arthritis (RA) that impedes on the ability to score the ESSDAI articular domain
- Systemic sclerosis
- Any other concurrent connective tissue disease (e.g., lupus nephritis (LN), large vessel vasculitis (LVV), Sharp syndrome (mixed connective tissue disease) that is active and requires immunosuppressive treatment outside the scope of this trial and would impede on Sjögren's Syndrome organ domain assessments
2. Use of other investigational drugs other than iscalimab during the core study
3. Active uncontrolled viral, bacterial or other infections requiring systemic treatment at the time of enrollment, or history of recurrent clinically significant infection or of bacterial infections with encapsulated organisms
Other protocol-defined inclusion/exclusion criteria may apply |
Les patients remplissant l'un des critères suivants ne sont pas éligibles pour inclusion dans cette étude :
1°: Le syndrome de Sjögren coïncide avec une autre maladie rhumatismale auto-immune constituant la maladie principale, à savoir :
• Lupus érythémateux systémique actif (LES) modéré à sévère, avec positivité des anti-ADNdb et atteinte rénale, ou autre atteinte d'un organe qui entrave l’évaluation des scores des domaines de l’ESSDAI
• Polyarthrite rhumatoïde active (PR) qui entrave l’évaluation du score du domaine articulaire de l’ESSDAI
• Sclérodermie systémique
• Toute autre maladie concomitante du tissu conjonctif [par ex., lupus rénal, vascularite des gros vaisseaux, syndrome de Sharp (maladies du collagène mixte)], active et nécessitant un traitement immunosuppresseur n'entrant pas dans le cadre de cet essai et susceptible d’entraver les évaluations des domaines organiques du syndrome de Sjögren
2°: Utilisation d’autres médicaments à l’essai que l’iscalimab pendant l’étude principale
3°: Infections actives non contrôlées virales, bactériennes ou autres nécessitant un traitement systémique au moment du recrutement, ou antécédents d'infections récurrentes cliniquement significatives ou d'infections bactériennes avec des organismes encapsulés
D'autre critères d'inclusion/d'exclusion définis par le protocole existent |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Incidence of Treatment-emergent adverse events (TEAEs)/ serious adverse events (SAEs)
Routine hematology and clinical chemistry laboratory test results at analysis visits up to end of study
Vital signs at analysis visits up to end of study |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
repeatedly until study completion (60 weeks) |
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E.5.2 | Secondary end point(s) |
1. Free iscalimab concentration in plasma during the treatment (Ctrough) and follow-up (up to end of study) periods
2. Incidence of anti-iscalimab antibodies in plasma at analysis visits up to end of study |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
repeatedly until study completion (60 weeks) |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Tolerability
Immunogenicity |
|
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
Double-blind until final database lock (DBL) of Core study (CFZ533B2201), open after DBL; 2 arms |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 40 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Argentina |
Australia |
Brazil |
Canada |
Chile |
Colombia |
Israel |
Japan |
Korea, Republic of |
Russian Federation |
Turkey |
United States |
Austria |
France |
Germany |
Greece |
Hungary |
Italy |
Netherlands |
Portugal |
Romania |
Slovenia |
Sweden |
United Kingdom |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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LVLS (last visit of the last subject) |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 5 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 2 |