E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
EOSINOPHILIC ESOPHAGITIS |
Esofagite Eosinofílica |
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E.1.1.1 | Medical condition in easily understood language |
Eosinophilic esophagitis (EoE) is a chronic disease that affects food intake and quality of life. |
Esofagite Eosinofílica (EoE) é uma doença crónica que afeta a ingestão de alimentos e qualidade de vida |
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E.1.1.2 | Therapeutic area | Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10064220 |
E.1.2 | Term | Eosinophilic esophagitis |
E.1.2 | System Organ Class | 100000004856 |
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E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the long-term safety and tolerability of CC-93538 in subjects with eosinophilic esophagitis (EoE). |
Avaliar a segurança e tolerabilidade do CC-93538 a longo prazo em participantes com Esofagite Eosinofílica(EoE) |
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E.2.2 | Secondary objectives of the trial |
To characterize the immunogenicity profile of CC-93538 following long-term treatment. |
Caracterizar o perfil de imunogenicidade do CC-93538 após tratamento a longo prazo |
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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 |
Title: Endolumenal Functional Lumen Imaging Probe (EndoFLIP TM) Sub-study Objective: An optional sub-study will be performed at a subset of clinical sites utilizing an Endolumenal Functional Lumen Imaging Probe (EndoFLIP) to evaluate the effects of CC-93538 on esophageal distensibility.
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E.3 | Principal inclusion criteria |
1 a. Subject must have participated in Study CC-93538-EE-001, and meets one of the following criteria: 1) Subject experienced a severe EoE flare requiring endoscopic intervention and/or concomitant rescue therapy during the Induction Phase and has completed Week 24 of the Induction Phase; OR 2) Subject completed the Induction Phase and does not qualify for entry to the Maintenance Phase for reasons other than a severe EoE flare; OR 3) Subject experienced a severe EoE flare requiring endoscopic intervention and/or concomitant rescue therapy during the Maintenance Phase and completed Week 48 of the Maintenance Phase; OR 4) Subject completed Week 48 of the Maintenance Phase b. OR Subject must have participated in Study CC-93538-DDI-001 and completed assessments in Period 2 through Week 18/End of Treatment Visit. 2. Demonstrated compliance with required investigational product dosing during the prior Study CC-93538-EE-001 or Study CC-93538-DDI- 001 and subject must not have been permanently discontinued from IP while participating in Study CC-93538-EE-001 or Study CC-93538-DDI- 001. 3. Subjects must have not experienced any clinically significant adverse events related to Investigational Product that would preclude further dosing. 4. Females of childbearing potential must have a negative pregnancy test prior to the first dose of open-label CC-93538 and agree to practice a highly effective method of contraception (as defined in the prior study) until 5 months after the last dose of open-label CC-93538. 5. Subject (18 years of age or older) must understand and voluntarily sign an informed consent form (ICF) prior to any study-related assessments/procedures being conducted. For subjects less than 18 years of age, subject assent must be obtained, and parental/legal representative consent is required. Adolescent subjects who reach the legal age of consent while participating in the study will be asked to sign an ICF (called a Transitional ICF) themselves to acknowledge their willingness to continue in the study. In Austria, Germany, Spain, and Switzerland, adolescent subjects will not be enrolled.
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E.4 | Principal exclusion criteria |
1. Clinical or endoscopic evidence of other diseases or conditions that may affect or confound the histologic, endoscopic, or clinical symptom evaluation for this study. 2. Subject demonstrates presence of esophageal varices. 3. Subject has a known active Helicobacter pylori infection and/or is currently being treated for this condition 4. Evidence of immunosuppression, or of having received systemic immunosuppressive or immunomodulating drugs within 5 drug half-lives prior to open-label extension study (OLE) Day 1. Use of these agents is prohibited during the study. 5. Treatment with oral or sublingual immunotherapy within 6 months of OLE Day 1. Use of these agents is prohibited during the study. 6. Received an investigational product, other than that administered in CC-93538-EE-001 or Study CC-93538-DDI-001, within 5 half-lives prior to OLE Day 1 (includes investigational product received during an interventional trial for COVID-19). Those vaccinated with an investigational COVID-19 vaccine during CC-93538-EE-001 or Study CC- 93538-DDI-001 are not eligible, unless allowed following a discussion with the Clinical Trial Physician. 7. Received a live attenuated vaccine within one month prior to OLE Day 1; or anticipates the need for a live attenuated vaccine at any time throughout the course of this study. 8. Any disease that would affect the conduct of the protocol or interpretation of the study results, or would put a patient at risk by participating in the study (e.g. colitis, celiac disease, Mendelian disorder associated with EoE, severe uncontrolled asthma, infection causing eosinophilia, hypereosinophilic syndrome, a documented medical diagnosis of gastritis, which is clinically significant in the judgment of the Investigator; colitis, celiac disease, Mendelian disorder associated with EoE, or cardiovascular condition, or neurologic or psychiatric illness that compromises the prospective subject's ability to accurately document symptoms of EoE). 9. Active or ongoing infections including parasitic/helminthic infections 10. Subject has a chronic infection (eg, hepatitis B or C, human immunodeficiency virus [HIV], or tuberculosis as defined by standard medical guidelines). |
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E.5 End points |
E.5.1 | Primary end point(s) |
Safety and tolerability of long-term treatment with CC-93538 evaluated by the incidence, severity, and relationship to CC-93538 of adverse events (AEs), serious adverse events (SAEs), clinical laboratory abnormalities, changes in vital signs, and physical examination abnormalities. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Baseline through Safety Follow-up Visit |
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E.5.2 | Secondary end point(s) |
Immunogenicity of CC-93538 assessed through the incidence of anti-drug antibodies, including neutralizing antibodies when warranted. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Baseline through Safety Follow-up Visit |
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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 | 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 | Yes |
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 | Yes |
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 | 1 |
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 | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 64 |
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 |
Switzerland |
Australia |
Austria |
Belgium |
Canada |
Germany |
Israel |
Italy |
Japan |
Poland |
Portugal |
Spain |
United Kingdom |
United States |
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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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The End of Study is defined as either the date of the last visit of the last subject to complete the post-treatment follow-up, or the date of receipt of the last data point from the last subject that is required for primary, secondary, and/or exploratory analysis, as pre-specified in the protocol, whichever is the later date. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 4 |
E.8.9.2 | In all countries concerned by the trial days | 0 |