Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 7:51 PM
Study NCT ID:
NCT07441395
Status:
RECRUITING
Last Update Posted:
2026-03-05
First Post:
2026-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate Soquelitinib in Participants With Moderate to Severe AD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003876', 'term': 'Dermatitis, Atopic'}, {'id': 'D004485', 'term': 'Eczema'}], 'ancestors': [{'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': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D017443', 'term': 'Skin Diseases, Eczematous'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-03', 'studyFirstSubmitDate': '2026-02-23', 'studyFirstSubmitQcDate': '2026-02-23', 'lastUpdatePostDateStruct': {'date': '2026-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent change from baseline in Eczema Area and Severity Index (EASI) score at Week 12', 'timeFrame': 'Baseline through Week 12', 'description': 'EASI is used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head and neck, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.'}], 'secondaryOutcomes': [{'measure': 'Response of achieving 75% reduction in EASI (EASI75) score at Week 12', 'timeFrame': 'Baseline through Week 12', 'description': 'EASI is used to measure the severity and extent of AD and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head and neck, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.'}, {'measure': 'Response of achieving validated Investigator Global Assessment (vIGA) score of 0 or 1 with reduction from Baseline of ≥2 points at Week 12', 'timeFrame': 'Baseline through Week 12', 'description': 'vIGA is an assessment scale used to determine severity of AD and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema, induration/papulation, lichenification and oozing/crusting, and takes extent of disease into account. Therapeutic response is a IGA score of 0 (clear) or 1 (almost clear).'}, {'measure': 'Response of achieving ≥4-point decrease in Peak Pruritus-Numerical Rating Scale (PP-NRS) score at Week 12', 'timeFrame': 'Baseline through Week 12', 'description': 'PP-NRS is a validated, single-item, patient-reported outcome of itch severity measured by an 11-point scale for worst itch over the last 24 hours'}, {'measure': 'Safety and tolerability', 'timeFrame': 'Up to 30 days after last intervention administration', 'description': 'Incidence, nature, and severity of treatment-emergent adverse events of soquelitinib compared with placebo, including changes in laboratory values, vital signs, and electrocardiograms (ECGs)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atopic Dermatitis', 'Atopic Dermatitis Eczema', 'Eczema', 'Eczema, Atopic']}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to see how well different doses of soquelitinib work in participants with atopic dermatitis (AD) as compared to a placebo (pill with no medicine in it). To check this, the study doctors will examine participants\' skin regularly to track how their AD changes during the study.\n\nThe study doctors will see how safe soquelitinib is by tracking side effects among participants. They will also check "tolerability," which means how well the participants can handle soquelitinib and whether any potential side effects are manageable for them.\n\nTo understand how well soquelitinib works, it will be compared with a placebo. Placebo is a substance that looks like soquelitinib but contains no active medicine in it.\n\nParticipants will:\n\n* Take study treatment (soquelitinib or placebo) every day for 12 weeks\n* Visit the clinic for check-ups and tests every week for the first 2 weeks then every 2 weeks during the treatment period, and then return for follow-up visits 30, 60, and 90 days after the last dose of study treatment'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adult male or female, ≥18 years of age, as applicable according to local legislation, at Screening.\n* Diagnosis of AD with onset of symptoms at least 1 year prior to the Screening visit.\n* Moderate to severe disease at screening and pre-randomization on Day 1 defined by:\n* EASI ≥16\n* Body surface area ≥10%\n* vIGA ≥3\n* PP-NRS average score of ≥4 over a period of 7 days prior to randomization at Day 1.\n* Documented history of prior topical and/or systemic therapy for AD within 6 months of randomization.\n* A female participant is eligible if she is not pregnant or breastfeeding, and is either of non-childbearing potential, OR of childbearing potential and agrees to use highly effective birth control\n\nExclusion Criteria:\n\n* Other concomitant skin conditions that would interfere with evaluations of the effect of study medication on AD.\n* Other active skin diseases or skin infections (bacterial, fungal, or viral) requiring systemic treatment within 30 days of the Baseline visit or that could interfere with the appropriate assessment of AD lesions.\n* Known immunodeficiency syndrome, history of an invasive infection or active non skin-related infection requiring systemic anti-infective treatment within 30 days of Baseline.\n* History of immunosuppression not related to medication, history of clinically significant medical conditions, or any other reason which in the opinion of the investigator would interfere with the participant's participation in this study.\n* Have an unstable or uncontrolled illness, including but not limited to cerebrocardiovascular, respiratory, gastrointestinal, endocrine, hematologic, or neurologic disorders that would potentially affect participant safety within the study or confound efficacy and safety assessments."}, 'identificationModule': {'nctId': 'NCT07441395', 'acronym': 'SIERRA1', 'briefTitle': 'Study to Evaluate Soquelitinib in Participants With Moderate to Severe AD', 'organization': {'class': 'INDUSTRY', 'fullName': 'Corvus Pharmaceuticals, Inc.'}, 'officialTitle': 'A Phase 2 Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Soquelitinib in Moderate to Severe Atopic Dermatitis (SIERRA1)', 'orgStudyIdInfo': {'id': 'CPI-818-006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1 - Soquelitinib 200 mg once daily', 'description': 'Participants will take the appropriate combination of soquelitinib and placebo tablets orally in the morning and evening daily for 12 weeks to ensure the proper dose and maintain blinding.', 'interventionNames': ['Drug: Soquelitinib', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2 - Soquelitinib 200 mg twice daily', 'description': 'Participants will take the appropriate combination of soquelitinib and placebo tablets orally in the morning and evening daily for 12 weeks to ensure the proper dose and maintain blinding.', 'interventionNames': ['Drug: Soquelitinib', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 3 - Soquelitinib 400 mg once daily', 'description': 'Participants will take the appropriate combination of soquelitinib and placebo tablets orally in the morning and evening daily for 12 weeks to ensure the proper dose and maintain blinding.', 'interventionNames': ['Drug: Soquelitinib', 'Drug: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo tablets will be taken orally twice daily for 12 weeks.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Soquelitinib', 'type': 'DRUG', 'otherNames': ['CPI-818'], 'description': 'Soquelitinib tablets', 'armGroupLabels': ['Cohort 1 - Soquelitinib 200 mg once daily', 'Cohort 2 - Soquelitinib 200 mg twice daily', 'Cohort 3 - Soquelitinib 400 mg once daily']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Soquelitinib matching placebo tablets', 'armGroupLabels': ['Cohort 1 - Soquelitinib 200 mg once daily', 'Cohort 2 - Soquelitinib 200 mg twice daily', 'Cohort 3 - Soquelitinib 400 mg once daily', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94080', 'city': 'South San Francisco', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Corvus Clinical Operations', 'role': 'CONTACT', 'email': 'CPI-818-006_Inquires@Corvuspharma.com', 'phone': '650-889-4390'}], 'facility': 'Corvus Clinical Trials', 'geoPoint': {'lat': 37.65466, 'lon': -122.40775}}], 'centralContacts': [{'name': 'Corvus Clinical Trials', 'role': 'CONTACT', 'email': 'CPI-818-006_Inquires@Corvuspharma.com', 'phone': '650-889-4390'}], 'overallOfficials': [{'name': 'Isin Sinem Bagci, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Corvus Pharmaceuticals, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Corvus Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}