Ignite Creation Date:
2024-07-17 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06477653
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-06-26
Brief Title:
Dupilumab as Add-On Therapy for Hypereosinophilic Syndrome With Partial Clinical Response to Eosinophil-Depleting Biologic Agents
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Pilot Phase 2 Study of the Safety and Efficacy of Dupilumab as Add-on Therapy for Hypereosinophilic Syndrome With Partial Clinical Response to Eosinophil-Depleting Biologic Agents
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background
Hypereosinophilic syndrome HES is a blood disorder that causes high levels of white blood cells called eosinophils HES can damage the lungs and airways intestines skin and other organs The current primary treatment for HES can cause serious side effects Secondary treatments do not work in all people
Objective
To test an approved drug dupilumab combined with other drugs in people with HES
Eligibility
People aged 18 years and older who take drugs mepolizumab reslizumab or benralizumab to treat HES
Design
Participants will have up to 6 clinic visits and 7 remote visits in up to 48 weeks
Participants will be screened They will have blood and urine tests They will have a test of their heart function They will take surveys about how HES affects their daily life Some participants may have a bone marrow biopsy A sample of tissue and fluid from inside a bone will be removed with a large needle
Participants will have other tests specific to their symptoms For example those with symptoms affecting their lungs will have breathing tests Others may have tests that target symptoms in their sinuses gastrointestinal tract or skin
Dupilumab is injected under the skin once every 1 or 2 weeks Dose and timing will vary among participants They will be taught how to inject themselves at home between clinic visits They will take dupilumab plus their current medications for 24 weeks If the drug is helping them they will continue taking it for another 24 weeks
Participants will have a final visit 12 weeks after their last dose
Hypereosinophilic syndrome HES is a blood disorder that causes high levels of white blood cells called eosinophils HES can damage the lungs and airways intestines skin and other organs The current primary treatment for HES can cause serious side effects Secondary treatments do not work in all people
Objective
To test an approved drug dupilumab combined with other drugs in people with HES
Eligibility
People aged 18 years and older who take drugs mepolizumab reslizumab or benralizumab to treat HES
Design
Participants will have up to 6 clinic visits and 7 remote visits in up to 48 weeks
Participants will be screened They will have blood and urine tests They will have a test of their heart function They will take surveys about how HES affects their daily life Some participants may have a bone marrow biopsy A sample of tissue and fluid from inside a bone will be removed with a large needle
Participants will have other tests specific to their symptoms For example those with symptoms affecting their lungs will have breathing tests Others may have tests that target symptoms in their sinuses gastrointestinal tract or skin
Dupilumab is injected under the skin once every 1 or 2 weeks Dose and timing will vary among participants They will be taught how to inject themselves at home between clinic visits They will take dupilumab plus their current medications for 24 weeks If the drug is helping them they will continue taking it for another 24 weeks
Participants will have a final visit 12 weeks after their last dose
Detailed Description:
Study Description
The purpose of this study is to evaluate the efficacy and tolerability of dupilumab in reducing clinical manifestations in patients with hypereosinophilic syndrome HES and persistent eosinophil-related pulmonary skin gastrointestinal or sinus symptoms despite eosinophil reduction in response to eosinophil-lowering biologic therapy Patients who meet criteria for HES and are currently receiving mepolizumab reslizumab or benralizumab with persistent symptoms as above despite absolute eosinophil count AEC05x109L will be eligible to enroll Participants will be treated with dupilumab at the US Food and Drug Administration FDA-approved doses for asthma atopic dermatitis chronic rhinosinusitis with nasal polyposis CRSwNP or eosinophilic esophagitis EoE depending on their residual symptoms Participants will have clinical evaluations and AEC measured every 4 weeks for 24 weeks Participants who remain in clinical remission and have an AEC05x109L will be eligible to continue dupilumab therapy for an additional 24 weeks with tapering of background therapy other than the eosinophil-lowering biologic as clinically tolerated
Objectives
Primary Objective To assess the efficacy of add-on dupilumab therapy in reducing residual pulmonary skin esophageal and sinus symptoms in patients with HES in complete hematologic and partial clinical remission on eosinophil-lowering biologics
Secondary Objective To determine the effect of eosinophil-lowering therapy on dupilumab-induced blood eosinophilia and eosinophil-associated AEs
Endpoints
Primary Endpoint Clinical improvement on dupilumab therapy at 24 weeks as assessed by HES-Most Bothersome Symptom HES-MBS and HES-Symptom Inventory HES-SI
Secondary Endpoints
1 Incidence of new or worsening symptoms or signs attributable to eosinophilia requiring therapeutic intervention through week 24
2 Peripheral blood AEC at 4 12 and 24 weeks
3 Proportion of patients who maintain an eosinophil count below 05x109L at 4 12 and 24 weeks
The purpose of this study is to evaluate the efficacy and tolerability of dupilumab in reducing clinical manifestations in patients with hypereosinophilic syndrome HES and persistent eosinophil-related pulmonary skin gastrointestinal or sinus symptoms despite eosinophil reduction in response to eosinophil-lowering biologic therapy Patients who meet criteria for HES and are currently receiving mepolizumab reslizumab or benralizumab with persistent symptoms as above despite absolute eosinophil count AEC05x109L will be eligible to enroll Participants will be treated with dupilumab at the US Food and Drug Administration FDA-approved doses for asthma atopic dermatitis chronic rhinosinusitis with nasal polyposis CRSwNP or eosinophilic esophagitis EoE depending on their residual symptoms Participants will have clinical evaluations and AEC measured every 4 weeks for 24 weeks Participants who remain in clinical remission and have an AEC05x109L will be eligible to continue dupilumab therapy for an additional 24 weeks with tapering of background therapy other than the eosinophil-lowering biologic as clinically tolerated
Objectives
Primary Objective To assess the efficacy of add-on dupilumab therapy in reducing residual pulmonary skin esophageal and sinus symptoms in patients with HES in complete hematologic and partial clinical remission on eosinophil-lowering biologics
Secondary Objective To determine the effect of eosinophil-lowering therapy on dupilumab-induced blood eosinophilia and eosinophil-associated AEs
Endpoints
Primary Endpoint Clinical improvement on dupilumab therapy at 24 weeks as assessed by HES-Most Bothersome Symptom HES-MBS and HES-Symptom Inventory HES-SI
Secondary Endpoints
1 Incidence of new or worsening symptoms or signs attributable to eosinophilia requiring therapeutic intervention through week 24
2 Peripheral blood AEC at 4 12 and 24 weeks
3 Proportion of patients who maintain an eosinophil count below 05x109L at 4 12 and 24 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 001979-I | None | None | None |