Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2025-12-25 @ 8:23 PM
Study NCT ID:
NCT07260669
Status:
RECRUITING
Last Update Posted:
2025-12-03
First Post:
2025-09-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Phase 2 Trial to Investigate Efficacy and Safety of Vipoglanstat in Women With Endometriosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004715', 'term': 'Endometriosis'}, {'id': 'D004412', 'term': 'Dysmenorrhea'}, {'id': 'D017699', 'term': 'Pelvic Pain'}], 'ancestors': [{'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D008599', 'term': 'Menstruation Disturbances'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 190}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-28', 'studyFirstSubmitDate': '2025-09-29', 'studyFirstSubmitQcDate': '2025-11-28', 'lastUpdatePostDateStruct': {'date': '2025-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants who meet the Predefined NMPP Responder Criteria from Baseline to Fourth Month of Treatment', 'timeFrame': 'Baseline to 4 months'}], 'secondaryOutcomes': [{'measure': 'Change in Mean Worst NMPP numeric Rating Scale (NRS) Score from Baseline to Fourth Month of Treatment', 'timeFrame': 'Baseline to 4 months'}, {'measure': 'Percentage of Participants who Meet the Predefined Dysmenorrhea Responder Criteria from Baseline to Fourth Month of Treatment', 'timeFrame': 'Baseline to 4 months'}, {'measure': 'Change in Mean Worst Dysmenorrhea NRS Score from Baseline to Fourth Month of Treatment', 'timeFrame': 'Baseline to 4 months'}, {'measure': 'Change in Endometriosis Health Profile 30 Item Patient Reported Outcome (EHP-30) Score from Baseline to End of Treatment', 'timeFrame': 'Baseline to 4 months'}, {'measure': 'Change in EHP-30 Sexual Intercourse Subscale Score from Baseline to End of Treatment', 'timeFrame': 'Baseline to 4 months'}, {'measure': 'Change in Mean Daily Opioid Rescue Medication Use for NMPP from Baseline to Fourth Month of Treatment', 'timeFrame': 'Baseline to 4 months'}, {'measure': 'Change in Mean Daily Opioid Rescue Medication Use for Dysmenorrhea from Baseline to Fourth Month of Treatment', 'timeFrame': 'Baseline to 4 months'}, {'measure': 'Number of Participants with Adverse Events', 'timeFrame': 'Up to 10 months', 'description': 'Any clinically significant changes in laboratory variables, including clinical chemistry, hematology, and urinalysis will be reported as adverse events.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Non-menstrual pelvic pain', 'Dysmenorrhea', 'Pelvic pain'], 'conditions': ['Endometriosis']}, 'descriptionModule': {'briefSummary': 'The main objective of the trial is to evaluate the efficacy of vipoglanstat on endometriosis-related non-menstrual pelvic pain (NMPP).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '44 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Premenopausal females 18 to \\< 45 years of age at the time of Visit 1.\n* Endometriosis diagnosis confirmed and documented within the last 10 years prior to Visit 1 or during Visit based on:\n\n * Surgical (via direct visualization or biopsy verified) or\n * Imaging (ie, endometriotic lesion(s) detected by transvaginal sonography or magnetic resonance imaging \\[MRI\\].\n* History of NMPP significantly affecting daily life confirmed at Visit 1.\n* The participant reports moderate, severe, or very severe pain during non-menstrual days in the month prior to Visit 2, based on patient global assessment NMPP.\n\nExclusion Criteria:\n\n* Chronic pelvic pain that is not judged to be primarily related to endometriosis (eg, chronic pelvic infection, interstitial cystitis, nerve entrapments or neuropathies, non-endometriosis-related pelvic adhesive disease, persistent symptomatic ovarian cyst \\[eg, dermoid\\], posttubal ligation, symptomatic hydrosalpinx, and vaginismus).\n* Has had more than 2 surgical procedures for endometriosis.'}, 'identificationModule': {'nctId': 'NCT07260669', 'acronym': 'NOVA', 'briefTitle': 'A Phase 2 Trial to Investigate Efficacy and Safety of Vipoglanstat in Women With Endometriosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gesynta Pharma AB'}, 'officialTitle': 'A Phase 2, Randomized, Double-blind, Placebo-controlled Trial to Investigate the Efficacy and Safety of 2 Doses of Vipoglanstat in Patients With Moderate to Severe Endometriosis-related Pain - the NOVA Trial', 'orgStudyIdInfo': {'id': 'GS-248-203'}, 'secondaryIdInfos': [{'id': '2025-522452-16-00', 'type': 'CTIS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dose A Vipoglanstat', 'interventionNames': ['Drug: Vipoglanstat']}, {'type': 'EXPERIMENTAL', 'label': 'Dose B Vipoglanstat', 'interventionNames': ['Drug: Vipoglanstat']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Vipoglanstat', 'type': 'DRUG', 'description': 'Participants will receive vipoglanstat capsules orally for approximately 4 menstrual cycles during the treatment period.', 'armGroupLabels': ['Dose A Vipoglanstat', 'Dose B Vipoglanstat']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Participants will receive matching placebo capsules orally for approximately 4 menstrual cycles during the treatment period.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'BD18 3SA', 'city': 'Bradford', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'Accellacare Yorkshire', 'geoPoint': {'lat': 53.79391, 'lon': -1.75206}}, {'zip': 'NN18 9EZ', 'city': 'Corby', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'Accellacare Northamptonshire', 'geoPoint': {'lat': 52.49637, 'lon': -0.68939}}, {'zip': 'CV3 4FJ', 'city': 'Coventry', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'Accellacare Warwickshire', 'geoPoint': {'lat': 52.40656, 'lon': -1.51217}}, {'zip': 'HA6 2RN', 'city': 'Northwood', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'Accellacare North London', 'geoPoint': {'lat': 51.61162, 'lon': -0.42454}}, {'zip': 'BR5 3QG', 'city': 'Orpington', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'Accellacare South London', 'geoPoint': {'lat': 51.37457, 'lon': 0.09785}}], 'centralContacts': [{'name': 'CMO VP Clinical Development', 'role': 'CONTACT', 'email': 'ctg@gesynta.se', 'phone': '+46 762 788 389'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gesynta Pharma AB', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}