Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 11:42 AM
Study NCT ID:
NCT07465120
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-11
First Post:
2026-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase Ⅱ Clinical Study to Evaluate the Efficacy and Safety of CMS-D001 in Adult Patients With Moderate to Severe Atopic Dermatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, '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': 160}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-08', 'studyFirstSubmitDate': '2026-03-08', 'studyFirstSubmitQcDate': '2026-03-08', 'lastUpdatePostDateStruct': {'date': '2026-03-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants achieving at least 75% improvement in Eczema Area and Severity Index (EASI 75)', 'timeFrame': 'At week 12'}], 'secondaryOutcomes': [{'measure': 'Number of participants achieving at least 75% improvement in EASI (EASI 75)', 'timeFrame': 'At weeks 2, 4, 8'}, {'measure': 'Number of participants achieving at least 50% or 90% improvement in EASI (EASI 50/90)', 'timeFrame': 'At weeks 2, 4, 8, 12'}, {'measure': "Number of participants achieving an Investigator's Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) with at least a 2-point reduction from baseline", 'timeFrame': 'At weeks 2, 4, 8, 12'}, {'measure': "Number of participants achieving an Investigator's Global Assessment (IGA) score of 0 or 1", 'timeFrame': 'At weeks 2, 4, 8, 12'}, {'measure': 'Number of participants achieving at least a 4-point reduction in Itch Numeric Rating Scale (Itch NRS) score from baseline', 'timeFrame': 'At weeks 2, 4, 8, 12'}, {'measure': 'Percentage change in EASI score from baseline', 'timeFrame': 'At weeks 2, 4, 8, 12'}, {'measure': 'Percentage change in SCORing Atopic Dermatitis (SCORAD) score from baseline', 'timeFrame': 'At weeks 2, 4, 8, 12'}, {'measure': 'Change in Itch Numeric Rating Scale (Itch NRS) score from baseline', 'timeFrame': 'At weeks 2, 4, 8, 12'}, {'measure': 'Percentage change in affected Body Surface Area (BSA) from baseline', 'timeFrame': 'At weeks 2, 4, 8, 12'}, {'measure': 'Change in Dermatology Life Quality Index (DLQI) score from baseline', 'timeFrame': 'At weeks 2, 4, 8, 12'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Moderate to Severe Atopic Dermatitis']}, 'descriptionModule': {'briefSummary': 'This study is a multicenter, randomized, double-blind, placebo-controlled Phase II clinical trial, aiming to evaluate the efficacy, safety, and tolerability of CMS-D001 in participants with moderate to severe atopic dermatitis, as well as to assess the pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of CMS-D001 and its major metabolites (as applicable) in participants with moderate to severe atopic dermatitis, so as to provide a basis for the dosage of the Phase III confirmatory clinical trial.', 'detailedDescription': "Approximately 160 participants with moderate to severe atopic dermatitis are planned to be enrolled and randomly assigned to four groups in a 1:1:1:1 ratio. Stratification will be performed based on participants' baseline IGA scores (3 or 4) at the time of randomization.\n\nEach participant will receive study treatment once daily (QD) for 12 consecutive weeks. The dosage and frequency for each group are as follows:\n\nTrial Group 1: CMS-D001 50 mg, QD; Trial Group 2: CMS-D001 100 mg, QD; Trial Group 3: CMS-D001 200 mg, QD; Control Group: Placebo, QD. The study is divided into three phases: a Screening Period (up to 4 weeks), a Treatment Period (12 weeks), and a Safety Follow-up Period (4 weeks after the last dose).\n\nDuring the study, all participants must adhere to the study visit schedule to undergo efficacy and safety assessments. They will also be required to complete blood sample collections for Pharmacokinetic (PK) and Pharmacodynamic (PD) evaluations, and information regarding Adverse Events (AEs) and concomitant medications will be collected."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18-75 years, willing to sign the ICF\n* Clinical diagnosis of AD (Hanifin \\& Rajka criteria) for ≥1 year\n* At screening and baseline, EASI score ≥ 16 points, IGA ≥ 3, BSA ≥ 10%, Itch NRS ≥ 4\n* Documented history of inadequate response to topical corticosteroids (TCS) or -topical calcineurin inhibitors (TCI).\n* Subject has applied a topical emollient (moisturizer) daily for at least 7 days prior to the Baseline Visit.\n\nExclusion Criteria:\n\n* Other active skin conditions that may interfere with AD assessment.\n* History of a serious bacterial, fungal, or viral infection requiring hospitalization or intravenous antimicrobial therapy within 3 months prior to the first dose.\n* History of a bacterial, fungal, or viral infection requiring oral antimicrobial therapy within 4 weeks prior to the first dose.\n* Active infection or acute illness within 7 days prior to the first dose.\n* Chronic or recurrent infectious diseases at screening or baseline that may increase safety risks.\n* Evidence of active TB. Patients with evidence of latent tuberculosis may enter the trial after sufficient treatment had initiated and maintained according to protocol.\n* History of a major or unstable clinical condition within 6 months prior to the first dose, which would compromise participation.\n* History of malignant tumour within 5 years before screening.\n* Previous or current autoimmune diseases.\n* Positive results of confirmatory test for hepatitis B, hepatitis C, human\n* immunodeficiency virus (HIV) or syphilis.\n* Allergic to any component of the investigational drug.'}, 'identificationModule': {'nctId': 'NCT07465120', 'briefTitle': 'A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase Ⅱ Clinical Study to Evaluate the Efficacy and Safety of CMS-D001 in Adult Patients With Moderate to Severe Atopic Dermatitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Dermavon Holdings Limited'}, 'officialTitle': 'A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase Ⅱ Clinical Study to Evaluate the Efficacy and Safety of CMS-D001 in Adult Patients With Moderate to Severe Atopic Dermatitis', 'orgStudyIdInfo': {'id': 'D001-02-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CMS-D001 50mg', 'interventionNames': ['Drug: CMS-D001 50mg']}, {'type': 'EXPERIMENTAL', 'label': 'CMS-D001 100mg', 'interventionNames': ['Drug: CMS-D001 100mg']}, {'type': 'EXPERIMENTAL', 'label': 'CMS-D001 200mg', 'interventionNames': ['Drug: CMS-D001 200mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'CMS-D001 50mg', 'type': 'DRUG', 'description': 'CMS-D001 50mg QD', 'armGroupLabels': ['CMS-D001 50mg']}, {'name': 'CMS-D001 100mg', 'type': 'DRUG', 'description': 'CMS-D001 100mg QD', 'armGroupLabels': ['CMS-D001 100mg']}, {'name': 'CMS-D001 200mg', 'type': 'DRUG', 'description': 'CMS-D001 200mg QD', 'armGroupLabels': ['CMS-D001 200mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo QD', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'contacts': [{'name': 'Zhang Haihong Beijing Huairou Hospital', 'role': 'CONTACT', 'email': 'm13811261579@163.com', 'phone': '13811261579'}], 'facility': 'Beijing Huairou Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'contacts': [{'name': 'Wei Aihua Beijing Tongren Hospital, Capital Medical University', 'role': 'CONTACT', 'email': 'weiaihua3000@163.com', 'phone': '15810585889'}], 'facility': 'Beijing Tongren Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'contacts': [{'name': 'Cui Yong China-Japan Friendship Hospital', 'role': 'CONTACT', 'email': 'wuhucuiyong@vip.163.com', 'phone': '15701625913'}], 'facility': 'China-Japan Friendship Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Fuzhou', 'state': 'Fujian', 'country': 'China', 'contacts': [{'name': 'Xiang Niu First Affiliated Hospital of Fujian Medical University', 'role': 'CONTACT', 'email': 'drnewnew@sina.com', 'phone': '13696834928'}], 'facility': 'First Affiliated Hospital of Fujian Medical University', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}, {'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'contacts': [{'name': 'Zhu Guannan Southern Medical University Dermatology Hospital', 'role': 'CONTACT', 'email': '18957118053@163.com', 'phone': '13750837205'}], 'facility': 'Southern Medical University Dermatology Hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Shenzhen', 'state': 'Guangdong', 'country': 'China', 'contacts': [{'name': 'Dou Xia Peking University Shenzhen Hospital', 'role': 'CONTACT', 'email': 'douxiaderm@163.com', 'phone': '13600156947'}], 'facility': 'Peking University Shenzhen Hospital', 'geoPoint': {'lat': 22.54554, 'lon': 114.0683}}, {'city': 'Haikou', 'state': 'Hainan', 'country': 'China', 'contacts': [{'name': "Zeng Huiming Hainan Provincial No.5 People's Hospital", 'role': 'CONTACT', 'email': '13976598200@163.com', 'phone': '13976598200'}], 'facility': "Hainan Provincial Fifth People's Hospital", 'geoPoint': {'lat': 20.03421, 'lon': 110.34651}}, {'city': 'Shijiazhuang', 'state': 'Hebei', 'country': 'China', 'contacts': [{'name': 'Li Yanling Hebei Medical University Second Hospital', 'role': 'CONTACT', 'email': 'lyldoctor@sina.com', 'phone': '15803212590'}], 'facility': 'Hebei Medical University Second Hospital', 'geoPoint': {'lat': 38.04139, 'lon': 114.47861}}, {'city': 'Tangshan', 'state': 'Hebei', 'country': 'China', 'contacts': [{'name': 'Sun Lindan Affiliated Hospital of North China University of Science and T', 'role': 'CONTACT', 'email': 'ahmusld@163.com', 'phone': '13856985045'}], 'facility': 'Affiliated Hospital of North China University of Science and Technology', 'geoPoint': {'lat': 39.64381, 'lon': 118.18319}}, {'city': 'Zhengzhou', 'state': 'Henan', 'country': 'China', 'contacts': [{'name': 'Chen Zixue', 'role': 'CONTACT', 'email': 'zxwygcp0371@163.com', 'phone': '13938459676'}], 'facility': 'Zhengzhou Central Hospital', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'city': 'Shiyan', 'state': 'Hubei', 'country': 'China', 'contacts': [{'name': "Meng Xiangdong Shiyan People's Hospital", 'role': 'CONTACT', 'email': '1970547910@qq.com', 'phone': '13997837543'}], 'facility': "Shiyan People's Hospital", 'geoPoint': {'lat': 32.6475, 'lon': 110.77806}}, {'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'contacts': [{'name': 'Shi Yuling Wuhan No.1 Hospital', 'role': 'CONTACT', 'email': 'chlq35@126.com', 'phone': '13971394978'}], 'facility': 'Wuhan No.1 Hospital', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'city': 'Suzhou', 'state': 'Jiangsu', 'country': 'China', 'contacts': 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Binzhou Medical University', 'role': 'CONTACT', 'email': 'doctor_malei@126.com', 'phone': '13905430770'}], 'facility': 'Affiliated Hospital of Binzhou Medical University', 'geoPoint': {'lat': 37.36667, 'lon': 118.01667}}, {'city': 'Jinan', 'state': 'Shandong', 'country': 'China', 'contacts': [{'name': 'Li Ying Qilu Hospital of Shandong University', 'role': 'CONTACT', 'email': '1145241793@qq.com', 'phone': '18560085070'}], 'facility': 'Qilu Hospital of Shandong University', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'contacts': [{'name': 'Shi Yuling Shanghai Dermatology Hospital', 'role': 'CONTACT', 'email': 'shiyuling1973@tongji.edu.cn', 'phone': '13816213884'}], 'facility': 'Shanghai Dermatology Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'contacts': [{'name': 'Li Xin Yueyang Hospital of Integrated Traditional 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'contacts': [{'name': 'Wang Huiping Tianjin Medical University General Hospital', 'role': 'CONTACT', 'email': 'who1109@163.com', 'phone': '13702031042'}], 'facility': 'Tianjin Medical University General Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'contacts': [{'name': "Wu Liming Hangzhou No.1 People's Hospital", 'role': 'CONTACT', 'email': '18957118053@163.com', 'phone': '13750837205'}], 'facility': "Hangzhou No.1 People's Hospital", 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'contacts': [{'name': "Liu Zequan Hangzhou Third People's Hospital", 'role': 'CONTACT', 'email': 'hzzehuliu@163.com', 'phone': '13758207597'}], 'facility': "Hangzhou Third People's Hospital", 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'contacts': [{'name': "Wu Liming Zhejiang Provincial People's Hospital", 'role': 'CONTACT', 'email': '13505811700@163.com', 'phone': '13505811700'}], 'facility': "Zhejiang Provincial People's Hospital", 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dermavon Holdings Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}