E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Thyroid Eye Disease (TED) |
Oftalmopatia tiroidea (TED) |
|
E.1.1.1 | Medical condition in easily understood language |
Thyroid Eye Disease (TED) |
Thyroid Eye Disease (TED) |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Eye Diseases [C11] |
MedDRA Classification |
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 describe batoclimab maintenance of efficacy as assessed by proptosis |
Descrivere il mantenimento dell’efficacia di batoclimab in base alla proptosi. |
|
E.2.2 | Secondary objectives of the trial |
• To describe the efficacy of batoclimab in participants previously treated with placebo and did not achieve proptosis response in the feeder studies
• To describe the treatment effect of batoclimab in participants previously treated with batoclimab but did not achieve proptosis response in the feeder studies |
Descrivere l’efficacia di batoclimab in partecipanti precedentemente trattati con placebo e che non hanno ottenuto una risposta della proptosi negli studi precedenti. Descrivere l’effetto del trattamento con batoclimab in partecipanti precedentemente trattati con batoclimab ma che non hanno ottenuto una risposta della proptosi negli studi precedenti. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
For all participants:
1. Have completed the Week 24 visit of the feeder study.
For participants assigned to the Open-label Treatment Cohort:
1. Do not require immediate surgical intervention and is not planning corrective surgery/irradiation or medical therapy for TED during the course of the study.
2. Did not permanently discontinue batoclimab
Additional inclusion criteria are defined in the protocol. |
Per tutti i partecipanti 1. Avere completato la visita della Settimana 24 degli studi precedenti. Per i partecipanti assegnati alla Coorte di trattamento in aperto 1. Non avere necessità di un intervento chirurgico immediato e non pianificare un intervento chirurgico/una radioterapia correttiva o terapia medica per TED durante il corso dello studio. 2. Non avere interrotto definitivamente batoclimab Altri criteri di inclusione descritti nel protocollo. |
|
E.4 | Principal exclusion criteria |
For all participants:
1. In the Investigator's judgement, the benefits of entry in the study do not outweigh the risk. |
Per tutti i partecipanti: 1. A giudizio dello sperimentatore, i benefici dell'ingresso nello studio non superano il rischio. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Duration of proptosis response off treatment in study eye in participants who were batoclimab responders in the feeder studies. |
Descrivere il mantenimento dell’efficacia di batoclimab in base alla proptosi. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
• Proportion of proptosis responders at Week 24 in study eye in participants who were placebo non-responders in the feeder studies.
• Proportion of proptosis responders at Week 24 in study eye in participants who were batoclimab non-responders in the feeder studies. |
Descrivere l’efficacia di batoclimab in partecipanti precedentemente trattati con placebo e che non hanno ottenuto una risposta della proptosi negli studi precedenti. Descrivere l’effetto del trattamento con batoclimab in partecipanti precedentemente trattati con batoclimab ma che non hanno ottenuto una risposta della proptosi negli studi precedenti. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
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 | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
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 | No |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
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 | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
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.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 39 |
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 | Information not present in EudraCT |
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 |
Canada |
Israel |
Japan |
United States |
Austria |
France |
Latvia |
Poland |
Sweden |
Netherlands |
Spain |
Switzerland |
Czechia |
Germany |
Italy |
Belgium |
Denmark |
Hungary |
Slovakia |
Turkey |
United Kingdom |
|
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
|
The end of study is defined as the date of the last visit of the last participant in the study. |
LVLS |
|
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 | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 5 |
E.8.9.2 | In all countries concerned by the trial days | 0 |