Ignite Creation Date:
2025-12-24 @ 3:37 PM
Ignite Modification Date:
2025-12-26 @ 10:20 AM
Study NCT ID:
NCT06005792
Status:
TERMINATED
Last Update Posted:
2025-12-02
First Post:
2023-08-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multiple Ascending-Dose Study of XmAb®27564 in Patients With Psoriasis or Atopic Dermatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011565', 'term': 'Psoriasis'}, {'id': 'D003876', 'term': 'Dermatitis, Atopic'}, {'id': 'D004485', 'term': 'Eczema'}], 'ancestors': [{'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D017443', 'term': 'Skin Diseases, Eczematous'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'whyStopped': 'Business Decision', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2022-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2024-11-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-24', 'studyFirstSubmitDate': '2023-08-15', 'studyFirstSubmitQcDate': '2023-08-15', 'lastUpdatePostDateStruct': {'date': '2025-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-08-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the safety and tolerability of multiple ascending dose subcutaneous (SC ) administration of XmAb27564', 'timeFrame': 'Day 57', 'description': "Safety and tolerability will be assessed by incidence of AE's; incidence of clinically significant changes in physical exams, vital signs, ECGs, and clinical laboratory testing; incidence of DLT's"}], 'secondaryOutcomes': [{'measure': 'To characterize pharmacokinetics', 'timeFrame': 'Day 57', 'description': 'Pharmacokinetics will be assessed by serum XmAb27564 concentrations'}, {'measure': 'To characterize pharmacodynamics', 'timeFrame': 'Day 57', 'description': 'Pharmacodynamics will be assessed by the change in number of regulatory T cells, conventional T cells, and natural killer cells (NK cells) in blood'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Psoriasis', 'Plaque Psoriasis', 'Atopic Dermatitis', 'Eczema'], 'conditions': ['Psoriasis', 'Atopic Dermatitis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and tolerability of XmAb27564 following multiple doses among participants with plaque psoriasis and atopic dermatitis.', 'detailedDescription': 'This is a phase 1b, randomized, double-blind, placebo-controlled, multiple ascending dose (MAD) study of XmAb27564. It is planned to enroll approximately 48 adult patients with mild-to-severe plaque psoriasis and 80 adult patients with moderate-to-severe atopic dermatitis. All patients will receive a total of 4 doses of study drug or placebo, administered subcutaneously every 2 weeks. A one year, open-label extension is available to qualifying patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nThe main inclusion and exclusion criteria include, but are not limited to, the following:\n\n* Have active mild-to-severe plaque psoriasis or moderate-to-severe atopic dermatitis according to study-specific criteria\n* Weight between 40 to 150 kg, inclusive\n* No topical treatments for psoriasis or atopic dermatitis for 2 weeks before randomization\n* No phototherapy for psoriasis for 4 weeks before randomization\n* Washout of oral treatments for psoriasis or atopic dermatitis for 4 weeks before randomization\n* Washout of biologic treatments for psoriasis or atopic dermatitis for 12 weeks before randomization\n* Stated willingness to comply with all study procedures (including skin biopsies) and availability for the duration of the study\n\nExclusion Criteria:\n\n* Patients with a history of active asthma within 5 years of screening, except those that have well controlled asthma symptoms at screening visit.\n* Patients who have had any prior investigational treatment with IL-2 therapies'}, 'identificationModule': {'nctId': 'NCT06005792', 'briefTitle': 'Multiple Ascending-Dose Study of XmAb®27564 in Patients With Psoriasis or Atopic Dermatitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Xencor, Inc.'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending-Dose Study of the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of XmAb27564 in Patients With Plaque Psoriasis and Atopic Dermatitis', 'orgStudyIdInfo': {'id': 'XmAb27564-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Plaque Psoriasis', 'interventionNames': ['Biological: XmAb27564', 'Biological: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Atopic Dermatitis', 'interventionNames': ['Biological: XmAb27564', 'Biological: Placebo']}], 'interventions': [{'name': 'XmAb27564', 'type': 'BIOLOGICAL', 'description': 'Subjects to receive four doses of XmAb27564 at one of six escalating dose-levels administered subcutaneously every 2 weeks (Q2W).', 'armGroupLabels': ['Atopic Dermatitis', 'Plaque Psoriasis']}, {'name': 'Placebo', 'type': 'BIOLOGICAL', 'description': 'Subjects to receive four doses of placebo administered subcutaneously every 2 weeks (Q2W).', 'armGroupLabels': ['Atopic Dermatitis', 'Plaque Psoriasis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91403', 'city': 'Sherman Oaks', 'state': 'California', 'country': 'United States', 'facility': 'Unison Clinical Trials', 'geoPoint': {'lat': 34.15112, 'lon': -118.44925}}, {'zip': '91320', 'city': 'Thousand Oaks', 'state': 'California', 'country': 'United States', 'facility': 'Clinical Trials Research Institute', 'geoPoint': {'lat': 34.17056, 'lon': -118.83759}}, {'zip': '33134', 'city': 'Coral Gables', 'state': 'Florida', 'country': 'United States', 'facility': 'Driven Research', 'geoPoint': {'lat': 25.72149, 'lon': -80.26838}}, {'zip': '33104', 'city': 'Miami Lakes', 'state': 'Florida', 'country': 'United States', 'facility': 'San Marcus Research Clinic', 'geoPoint': {'lat': 25.90871, 'lon': -80.30866}}, {'zip': '77845', 'city': 'College Station', 'state': 'Texas', 'country': 'United States', 'facility': 'J&S Studies, Inc', 'geoPoint': {'lat': 30.62798, 'lon': -96.33441}}, {'zip': '77598', 'city': 'Webster', 'state': 'Texas', 'country': 'United States', 'facility': 'Center for Clinical Studies, LTD. LLP', 'geoPoint': {'lat': 29.53773, 'lon': -95.11826}}, {'zip': 'H2X 2V1', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Innovaderm Research Inc.', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Ralph Zitnik, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Executive Medical Director, Clinical Development, Xencor, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xencor, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}