Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-26 @ 4:46 AM
Study NCT ID:
NCT06340360
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-03
First Post:
2024-03-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase 2b Study to Evaluate Rezpegaldesleukin (Rezpeg) in the Treatment of Severe to Very Severe Alopecia Areata in Adult Patients (Rezolve AA)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000506', 'term': 'Alopecia Areata'}], 'ancestors': [{'id': 'D000505', 'term': 'Alopecia'}, {'id': 'D007039', 'term': 'Hypotrichosis'}, {'id': 'D006201', 'term': 'Hair Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020742', 'term': 'rhoA GTP-Binding Protein'}], 'ancestors': [{'id': 'D020741', 'term': 'rho GTP-Binding Proteins'}, {'id': 'D020559', 'term': 'Monomeric GTP-Binding Proteins'}, {'id': 'D019204', 'term': 'GTP-Binding Proteins'}, {'id': 'D020558', 'term': 'GTP Phosphohydrolases'}, {'id': 'D017766', 'term': 'Acid Anhydride Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D002352', 'term': 'Carrier Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D047908', 'term': 'Intracellular Signaling Peptides and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients will be randomized to 1 of 3 groups (low dose, high dose, or placebo).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 94}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-04-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-31', 'studyFirstSubmitDate': '2024-03-25', 'studyFirstSubmitQcDate': '2024-03-25', 'lastUpdatePostDateStruct': {'date': '2025-11-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent change from baseline in Severity of Alopecia Tool (SALT) score at Week 36', 'timeFrame': 'Baseline and Week 36', 'description': 'The SALT score is the sum of percentage of hair loss in all areas with a maximum score of 100 (higher score indicates greater hair loss).'}], 'secondaryOutcomes': [{'measure': 'Percent change from baseline in SALT score', 'timeFrame': 'Baseline and Weeks 12, 16, 20, 24, 28, and 32', 'description': 'SALT score is the sum of percentage of hair loss in all areas with a maximum score of 100 (higher score indicates greater hair loss).'}, {'measure': 'Proportion of patients achieving improvement in Severity of Alopecia Tool (SALT) ≥ 50%/75%/90%', 'timeFrame': 'Baseline and Weeks 12, 16, 20, 24, 28, 32, and 36', 'description': 'Proportion of patients achieving improvement of ≥ 50%/75%/90% in Severity of Alopecia Tool (SALT) relative to their baseline score (SALT50/75/90). SALT score is the sum of percentage of hair loss in all areas with a maximum score of 100 (higher score indicates greater hair loss).'}, {'measure': 'Proportion of patients achieving an absolute SALT score ≤ 10/20/30/50', 'timeFrame': 'Baseline and Weeks 12, 16, 20, 24, 28, 32, and 36', 'description': 'Proportion of patients achieving an absolute SALT score of ≤ 10/20/30/50. SALT score is the sum of percentage of hair loss in all areas (higher score indicates greater hair loss). Total percentage of patients with absolute SALT score of ≤ 10/20/30/50 will be calculated.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Alopecia Areata']}, 'descriptionModule': {'briefSummary': 'This is an interventional, randomized, double blind, parallel group, placebo-controlled, Phase 2b, 3-arm study to assess the effect of pegylated-recombinant-human interleukin-2 (rezpegaldesleukin) in adult participants with severe to very severe alopecia areata.\n\nThe estimated duration includes a screening period of up to 35 days, a 36-week treatment period, an optional 16-week treatment extension period, and a 24-week follow-up period. The maximum study duration is approximately 81 weeks for all participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults who are at least 18 years and ≤60 years for males (≤70 years of age for females) old at the time of informed consent\n* Diagnosis of Alopecia Areata (AA) severity at screening and baseline:\n\n 1. severe to very severe AA (≥ 50% scalp involvement) as measured using the SALT score\n 2. Documented history over 6 months with no spontaneous improvement prior to baseline\n 3. Current episode of severe to very severe AA of less than 8 years\n* Women of childbearing potential (WOCBP) must have a negative pregnancy test at screening and baseline.\n* While on investigational product and for at least 30 days after taking the last dose of investigational product (IP), WOCBP who engage in activity in which conception is possible must use approved highly effective contraceptive method(s). For male patient with partner that is WOCBP in which conception is possible, male patient must agree to use approved highly effective contraceptive method(s).\n* Able to complete patient questionnaires\n* Able and willing to comply with requested study visits and procedures\n* Able and willing to provide written informed consent\n* Able to communicate, read and/or understand the local language\n\nExclusion Criteria:\n\n* Men and women (of reproductive potential) unwilling to use birth control and women who are pregnant or breastfeeding.\n* Patient has primarily "diffuse" type AA (characterized by diffuse hair shedding).\n* Presence of another form of alopecia.\n* Prior use of any of the following treatments:\n\n 1. aldesleukin\n 2. investigational IL-2 analog\n 3. oral Janus kinase (JAK) inhibitor for any indication, including, but not limited to, baricitinib, upadacitinib, abrocitinib, tofacitinib, and ruxolitinib, whether marketed or investigational\n 4. systemic immune-modulating biologic therapy (including, but not limited to, dupilumab, tralokinumab, lebrikizumab, nemolizumab, rocatinlimab, rituximab, ocrelizumab, ofatumumab, belimumab, daxdilimab, etc.) whether marketed or investigational\n* History of cancer or lymphoproliferative disease within 5 years prior to Day 1. Note: Patients with successfully treated nonmetastatic cutaneous squamous cell or basal cell carcinoma with no evidence of metastatic disease for 3 years and/or localized carcinoma in situ of the cervix with no evidence of recurrence within the 3 years prior to Day 1 are not to be excluded.\n* Current infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) at screening.\n* Other skin conditions that would interfere with study assessments of AA'}, 'identificationModule': {'nctId': 'NCT06340360', 'briefTitle': 'A Phase 2b Study to Evaluate Rezpegaldesleukin (Rezpeg) in the Treatment of Severe to Very Severe Alopecia Areata in Adult Patients (Rezolve AA)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nektar Therapeutics'}, 'officialTitle': 'A Phase 2b, Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Rezpegaldesleukin in the Treatment of Severe to Very Severe Alopecia Areata in Adult Patients (Rezolve AA)', 'orgStudyIdInfo': {'id': '23-358-06'}, 'secondaryIdInfos': [{'id': '2023-509981-39', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Low Dose', 'description': 'Rezpegaldesleukin Low Dose Every 2 weeks', 'interventionNames': ['Drug: Rezpegaldesleukin']}, {'type': 'EXPERIMENTAL', 'label': 'High Dose', 'description': 'Rezpegaldesleukin High Dose Every 2 weeks', 'interventionNames': ['Drug: Rezpegaldesleukin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo Every 2 weeks', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Rezpegaldesleukin', 'type': 'DRUG', 'otherNames': ['REZPEG', 'NKTR-358', 'LY3471851 (formerly)'], 'description': 'Pharmaceutical form: Injection solution Route of administration: subcutaneous', 'armGroupLabels': ['High Dose', 'Low Dose']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Pharmaceutical form: Injection solution Route of administration: subcutaneous', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91324', 'city': 'Northridge', 'state': 'California', 'country': 'United States', 'facility': 'Nektar Investigative Site', 'geoPoint': {'lat': 34.22834, 'lon': -118.53675}}, {'zip': '30331', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Nektar Investigative Site', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60031', 'city': 'Gurnee', 'state': 'Illinois', 'country': 'United States', 'facility': 'Nektar Investigative Site', 'geoPoint': {'lat': 42.3703, 'lon': -87.90202}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Nektar Investigative Site', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '48038', 'city': 'Clinton Township', 'state': 'Michigan', 'country': 'United States', 'facility': 'Nektar Investigative Site', 'geoPoint': {'lat': 42.58698, 'lon': 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'Wroclaw', 'state': 'Lower Silesian Voivodeship', 'country': 'Poland', 'facility': 'Nektar Investigative Site', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}, {'zip': '51-685', 'city': 'Wroclaw', 'state': 'Lower Silesian Voivodeship', 'country': 'Poland', 'facility': 'Nektar Investigative Site', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}, {'zip': '67-100', 'city': 'Nowa Sól', 'state': 'Lubusz Voivodeship', 'country': 'Poland', 'facility': 'Nektar Investigative Site', 'geoPoint': {'lat': 51.80333, 'lon': 15.71702}}, {'zip': '02-482', 'city': 'Warsaw', 'state': 'Masovian Voivodeship', 'country': 'Poland', 'facility': 'Nektar Investigative Site', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '02-953', 'city': 'Warsaw', 'state': 'Masovian Voivodeship', 'country': 'Poland', 'facility': 'Nektar Investigative Site', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '80-546', 'city': 'Gdansk', 'state': 'Pomeranian Voivodeship', 'country': 'Poland', 'facility': 'Nektar Investigative Site', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}, {'zip': '40-611', 'city': 'Katowice', 'state': 'Silesian Voivodeship', 'country': 'Poland', 'facility': 'Nektar Investigative Site', 'geoPoint': {'lat': 50.2597, 'lon': 19.02173}}, {'zip': '41-200', 'city': 'Sosnowiec', 'state': 'Silesian Voivodeship', 'country': 'Poland', 'facility': 'Nektar Investigative Site', 'geoPoint': {'lat': 50.28682, 'lon': 19.10385}}, {'zip': '10-229', 'city': 'Olsztyn', 'state': 'Warmian-Masurian Voivodeship', 'country': 'Poland', 'facility': 'Nektar Investigative Site', 'geoPoint': {'lat': 53.78376, 'lon': 20.49272}}, {'zip': '71-500', 'city': 'Szczecin', 'state': 'West Pomeranian Voivodeship', 'country': 'Poland', 'facility': 'Nektar Investigative Site', 'geoPoint': {'lat': 53.42894, 'lon': 14.55302}}], 'overallOfficials': [{'name': 'Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Nektar Therapeutics'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nektar Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}