Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2025-12-31 @ 3:33 AM
Study NCT ID:
NCT06993233
Status:
RECRUITING
Last Update Posted:
2025-11-20
First Post:
2025-05-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study With CIT-013 in HS Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017497', 'term': 'Hidradenitis Suppurativa'}], 'ancestors': [{'id': 'D017192', 'term': 'Skin Diseases, Bacterial'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012874', 'term': 'Skin Diseases, Infectious'}, {'id': 'D013492', 'term': 'Suppuration'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D016575', 'term': 'Hidradenitis'}, {'id': 'D013543', 'term': 'Sweat Gland 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': 96}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2025-05-19', 'studyFirstSubmitQcDate': '2025-05-19', 'lastUpdatePostDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-05-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of participants with HiSCR75 on CIT 013 versus placebo', 'timeFrame': 'week 12'}], 'secondaryOutcomes': [{'measure': 'Incidence of TEAEs as assessed by CTCAE', 'timeFrame': 'week 12'}, {'measure': 'Maximum Plasma Concentration of CIT-013 before doses', 'timeFrame': '4, 6, 10 and 12 weeks'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hidradenitis Suppurativa (HS)']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn if CIT-013 works to treat Hidradenitis Suppurativa in adults. It will also learn about the safety of CIT-013. The main questions it aims to answer are:\n\nDoes CIT-013 lower the disease activity of HS patients? What medical problems do participants have when receiving CIT-013? Researchers will compare CIT-013 to a placebo (a look-alike substance that contains no drug) to see if CIT-013 works to treat the symptoms of HS.\n\nParticipants will:\n\nTake receive 50 or 100 mg CIT-013 or placebo every other week for 12 weeks Visit the clinic once every 2 weeks for checkups and tests Keep monitor their symptoms during this period'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female participants with HS of more than 6 months duration,\n* 18 years of age at screening visit,\n* Hidradenitis suppurativa lesions present in ≥ 2 distinct anatomic areas, one of which is Hurley Stage II or III (according to Hurley classification system),\n* A total abscess and inflammatory nodule (AN) count of ≥ 5 at screening and Day 1 prior to enrollment/randomization,\n* Participant must have had an inadequate response to oral antibiotics OR exhibited recurrence after discontinuation to, OR demonstrated intolerance to, OR have a contraindication to oral antibiotics for treatment of their HS,\n* Total draining tunnel count less than 20\n\nExclusion Criteria:\n\n* Any current and/or recurrent clinically significant skin condition in the treatment area other than HS,\n* Prior treatment with a recombinant therapeutic protein during the 6 weeks before baseline\n* Prior treatment with any of the following medications before baseline:\n\n 1. Any other systemic therapy for HS (28 days before baseline)\n 2. Any IV anti-infective therapy (14 days before baseline)\n* History of malignancy with exception of non-melanoma skin cancer that has been excised and cured,'}, 'identificationModule': {'nctId': 'NCT06993233', 'acronym': 'Citylights', 'briefTitle': 'A Study With CIT-013 in HS Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Citryll BV'}, 'officialTitle': 'A Phase 2a Double Blind, Randomized, Parallel Arm, Placebo-controlled Trial to Investigate the Effects of Two Dose Levels of CIT-013 on Disease Activity in Patients With Hidradenitis Suppurativa', 'orgStudyIdInfo': {'id': 'CITRYLL003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CIT-013 high dose', 'description': '6 SC injections with CIT-013 high dose', 'interventionNames': ['Drug: CIT-013 high dose']}, {'type': 'EXPERIMENTAL', 'label': 'CIT-013 medium dose', 'description': '6 SC injections with CIT-013 medium dose', 'interventionNames': ['Drug: CIT-013 medium dose']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '6 SC injections with placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'CIT-013 high dose', 'type': 'DRUG', 'description': 'subcutaneous injection', 'armGroupLabels': ['CIT-013 high dose']}, {'name': 'CIT-013 medium dose', 'type': 'DRUG', 'description': 'subcutaneous injection', 'armGroupLabels': ['CIT-013 medium dose']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'subcutaneous injection', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Rotterdam', 'status': 'NOT_YET_RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'PI NL-01', 'role': 'CONTACT'}], 'facility': 'Erasmus UMC', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'city': 'Chester', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'PI UK-05', 'role': 'CONTACT', 'email': 'lmiddelink@citryll.com', 'phone': '+44 0203 865 1142'}], 'facility': 'GB-05', 'geoPoint': {'lat': 53.1905, 'lon': -2.89189}}], 'centralContacts': [{'name': 'Leonie M Middelink', 'role': 'CONTACT', 'email': 'lmiddelink@citryll.com', 'phone': '+31613328444'}], 'overallOfficials': [{'name': 'Maarten Kraan', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Citryll BV'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Citryll BV', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}