Nctid:
NCT06226610
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000011537", "term"=>"Pruritus"}], "ancestors"=>[{"id"=>"D000012871", "term"=>"Skin Diseases"}, {"id"=>"D000012877", "term"=>"Skin Manifestations"}], "browseLeaves"=>[{"id"=>"M5326", "name"=>"Burns", "relevance"=>"LOW"}, {"id"=>"M14396", "name"=>"Pruritus", "asFound"=>"Pruritus", "relevance"=>"HIGH"}, {"id"=>"M15674", "name"=>"Skin Diseases", "relevance"=>"LOW"}, {"id"=>"M15680", "name"=>"Skin Manifestations", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Wounds and Injuries", "abbrev"=>"BC26"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Skin and Connective Tissue Diseases", "abbrev"=>"BC17"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE2"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"TRIPLE", "whoMasked"=>["PARTICIPANT", "CARE_PROVIDER", "INVESTIGATOR"], "maskingDescription"=>"The study sponsor will supply all study drug (including placebo) as blinded kits. Study staff, investigators, and participants will be blinded to which treatment condition a participant has been randomized to. Note that the drug manufacturer will email codes to the pharmacists (who are unblinded) identifying the appropriate study drug for a particular participant. It is possible that participants may become unblinded to the obvious physical effects related to receiving Dupixent or placebo (pruritus improves or does not improve). Study staff will not discuss or speculate potential treatment arm allocation with participants based on participants' comments, questions, daily itch diary data, or physical observation. Study staff will encourage participants expressing resentful demoralization to remain in the study through their final visit."}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL", "interventionModelDescription"=>"This is a dual-arm, two-site, randomized, placebo-controlled interventional Phase 2 randomized controlled clinical trial to estimate the potential effect size of Dupixent on improving post-burn pruritus symptoms. N=46 participants will be enrolled at a 1:1 intervention:control ratio."}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>46}}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-02-01", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2026-12-31", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-01-18", "studyFirstSubmitDate"=>"2024-01-18", "studyFirstSubmitQcDate"=>"2024-01-18", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-26", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-26", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2026-01-31", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"ITCH SEVERITY SCALE SCORES", "timeFrame"=>"12 WEEKS", "description"=>"participants' Itch Severity Scale (ISS) scores will decrease more than 2.0 points after 12 weeks following initiating use of Dupixent"}]}, "oversightModule"=>{"isUsExport"=>true, "oversightHasDmc"=>true, "isFdaRegulatedDrug"=>true, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Itching, itch"], "conditions"=>["Pruritis"]}, "descriptionModule"=>{"briefSummary"=>"The goal of this study is to test the efficacy of Dupixent in improving post-burn itching symptoms versus the current standard of care.", "detailedDescription"=>"Participants will receive six injections of Dupixent or placebo (two 300 mg loading doses and one 300 mg dose every two weeks after that).\n\nIn addition, they will be asked to complete questionnaires to determine daily itch severity, quality of life, treatment benefit, physical functioning, and pain interference.\n\nIndividual participants will require 13 weeks to complete all study visits."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT"], "maximumAge"=>"60 years", "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Persons 18-60 year old with post-burn hypertrophic scars of any size which required grafting or epidermal autografting for an acute burn injury, with continued complaint of pruritus due to inadequate relief from standard of care (medical management by antihistamine and neuroleptic medications) after at least four weeks and are a minimum of four weeks after their last grafting surgery, and who speak English sufficient to participate in the study.\n\nExclusion Criteria:\n\n1. Currently taking Dupixent for any other diagnosis\n2. known allergy to Dupixent\n3. pregnant and or lactating mothers\n4. anyone treated for pruritus using laser therapy\n5. currently receiving adequate relief for pruritis under standard of care medical management by antihistamine or neuroleptic medications\n6. Currently taking steroids\n7. persons with developmental delays or otherwise unable to complete measures\n8. prisoners or anyone otherwise unable to give their own consent or who is not their own guardian\n9. one or more of the following existing disorders: conjunctivitis; any co-existing dermatological condition except burns; any type of cancer; requiring dialysis; chronic Stage 3 or higher kidney disease; biliary disorder; gall bladder disorder; or another renal or hepatic disorder which, in the opinion of study physician, deems this study inappropriate for an eligible individual.\n10. Persons unable to provide their own consent, including prisoners when their incarcerated status is not itself the focus of study, are routinely excluded from clinical trials at this site\n11. We further exclude persons with other dermatological conditions (other than burn) , which may have pruritis or pain associated with them and who may be treated with medications other than Dupixent, and whose perceived benefit could confound our results.\n12. We similarly exclude anyone treated for pruritis by laser therapy as their perceived benefit could confound our results."}, "identificationModule"=>{"nctId"=>"NCT06226610", "briefTitle"=>"Dupixent in Adults With Refractory Post-Burn Pruritus in an Ambulatory Clinic", "organization"=>{"class"=>"OTHER", "fullName"=>"Akron Children's Hospital"}, "officialTitle"=>"A Phase 2 Double-Blind, Randomized, Placebo-Controlled Study to Assess the Efficacy of Dupixent in Adults With Refractory Post-Burn Pruritus in an Ambulatory Clinic", "orgStudyIdInfo"=>{"id"=>"2024-002"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"ACTIVE_COMPARATOR", "label"=>"ARM 1 - Dupixent", "description"=>"Two subcutaneous injection of 300mg Dupixent at visit 1 and every two weeks (+/- 2 days) for a total of 6 administrations. Injections may be administered in the thigh, lower abdomen or upper arm. The initial dose (two 300 mg doses) will be given in two different injection sites. There are not restriction or guidance regarding dose administration related to meals. No dose modifications will occur during study participation.", "interventionNames"=>["Drug: Dupilumab"]}, {"type"=>"PLACEBO_COMPARATOR", "label"=>"ARM 2 - Placebo", "description"=>"Two subcutaneous injection of the placebo at visit 1 and every two weeks (+/- 2 days) for a total of 6 administrations. Injections may be administered in the thigh, lower abdomen or upper arm. The initial dose (two doses) will be given in two different injection sites. There are not restriction or guidance regarding dose administration related to meals. No dose modifications will occur during study participation.", "interventionNames"=>["Other: Placebo"]}], "interventions"=>[{"name"=>"Dupilumab", "type"=>"DRUG", "description"=>"injection every two weeks while on study", "armGroupLabels"=>["ARM 1 - Dupixent"]}, {"name"=>"Placebo", "type"=>"OTHER", "description"=>"injection every two weeks while on study", "armGroupLabels"=>["ARM 2 - Placebo"]}]}, "contactsLocationsModule"=>{"centralContacts"=>[{"name"=>"ANJAY KHANDELWAL, MD", "role"=>"CONTACT", "email"=>"akhandelwal@akronchildrens.org", "phone"=>"330-543-4649"}, {"name"=>"Jo Ann Katz, BSN", "role"=>"CONTACT", "email"=>"jkatz@akronchildrens.org", "phone"=>"330-543-0690"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Akron Children's Hospital", "class"=>"OTHER"}, "collaborators"=>[{"name"=>"Regeneron Pharmaceuticals", "class"=>"INDUSTRY"}, {"name"=>"Ohio State University", "class"=>"OTHER"}], "responsibleParty"=>{"type"=>"SPONSOR"}}}}
