Ignite Creation Date:
2025-12-24 @ 7:47 PM
Ignite Modification Date:
2026-01-04 @ 9:01 PM
Study NCT ID:
NCT05187403
Status:
COMPLETED
Last Update Posted:
2023-01-31
First Post:
2021-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Laquinimod Eye-drops in Healthy Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C476223', 'term': 'laquinimod'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-12-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2023-01-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-30', 'studyFirstSubmitDate': '2021-12-06', 'studyFirstSubmitQcDate': '2022-01-10', 'lastUpdatePostDateStruct': {'date': '2023-01-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse events', 'timeFrame': 'For 7 days post-dose', 'description': 'Type, frequency, seriousness, severity and relationship to treatment'}], 'secondaryOutcomes': [{'measure': 'Participant-reported eye-toxicities', 'timeFrame': 'Pre-dose (baseline) and immediately after the intervention', 'description': 'Assessed from change from baseline in ocular symptoms score determined using a Visual Analogue Scale with 0-100 range, where 0= no symptom and 100= worst possible discomfort.'}, {'measure': 'Investigator-reported eye-toxicities - BCVA', 'timeFrame': 'Pre-dose (baseline) and immediately after the intervention', 'description': 'Assessed from change from baseline in Best Corrected Visual Acuity (BCVA) using the Early Treatment Diabetic Retinopathy Study research group (ETDRS) visual acuity chart with objective and subjective refraction.'}, {'measure': 'Investigator-reported eye-toxicities - Slit lamp examination', 'timeFrame': 'Pre-dose (baseline) and immediately after the intervention', 'description': 'Assessed from change from baseline in slit lamp examination parameters (eyelid swelling, eyelid redness, conjunctival redness, conjunctival chemosis, scleral redness, corneal opacity, iris alterations and anterior chamber flare) graded on a 4-point scale where 0= none, 1= mild, 2= moderate, and 3= severe.'}, {'measure': 'Investigator-reported eye-toxicities - Corneal fluorescein staining', 'timeFrame': 'At screening visit (baseline) and immediately after the intervention', 'description': 'Assessed from change from baseline in corneal fluorescein staining determined using the NEI/Industry Workshop guidelines. The cornea is divided into five sectors (central, superior, inferior, nasal and temporal) and each sector scored on a 4-point scale, where 0= no staining and 3= maximum staining.'}, {'measure': 'Investigator-reported eye-toxicities - Intraocular pressure', 'timeFrame': 'At screening visit (baseline) and immediately after the intervention', 'description': 'Assessed from change from baseline in intraocular pressure (mmHg) determined using a Goldmann applanation tonometer.'}, {'measure': 'Investigator-reported eye-toxicities - Funduscopy in mydriasis', 'timeFrame': 'At screening visit (baseline) and immediately after the intervention', 'description': 'Assessed from change from baseline in clinical signs detected by indirect funduscopic inspection of the optic disc, macula, retinal vessels and retinal periphery.'}, {'measure': 'Peak plasma concentration of laquinimod', 'timeFrame': 'Over up to 21 days after (last) dose', 'description': 'Maximal plasma concentration (Cmax) of laquinimod as assessed from samples collected pre-dose and at frequent intervals over 7 days after (last) dose'}, {'measure': 'Time to peak plasma concentration of laquinimod', 'timeFrame': 'Over up to 21 days) after (last) dose', 'description': 'Time to maximal plasma concentration (tmax) of laquinimod as assessed from samples collected pre-dose and at frequent intervals over 7 days after (last) dose'}, {'measure': 'Trough plasma concentration of laquinimod at steady-state', 'timeFrame': 'On the last three days of multiple dosing', 'description': 'Minimal plasma concentration (Cmin,ss) of laquinimod as assessed from samples collected pre-dose on Days 12, 13 and 14 within the multiple-dose arm'}, {'measure': 'Systemic exposure of laquinimod', 'timeFrame': 'Over up to 21 days after (last) dose', 'description': 'Area under the plasma concentration time curve (AUC) of laquinimod'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Eye Diseases']}, 'descriptionModule': {'briefSummary': 'This is a Phase 1 randomized, double-masked, placebo-controlled study performed with healthy participants to assess the safety and tolerability of laquinimod eye-drops.', 'detailedDescription': 'Laquinimod administered as an oral capsule formulation has previously been studied in neurodegenerative and autoimmune diseases. The clinical side effect profile of orally administered laquinimod is well-characterized based on this previous experience.\n\nThis trial will establish a safe and tolerated dose of laquinimod when administered as an eye-drop formulation following single ascending dose (SAD) and multiple ascending dose (MAD) administrations. There are four planned groups in the SAD-part of the study which will enroll 28 participants, if all dose levels are explored. The subsequent MAD-part of the study will enroll another 28 participants.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Main inclusion criteria:\n\n* In good health according to medical history, physical examination, vital signs, ECG and clinical chemistry, urinary and hematological laboratory tests\n\nMain exclusion criteria:\n\n* Unable or unwilling to use eye-drops\n* Current usage of contact lenses\n* History of eye surgery\n* Sign or symptom of active eye disease\n* History of an eye disease or other condition that could interfere with eye examinations in the study, or with ocular absorption of the investigational product\n* History of inflammatory ocular disease\n* History of cardiovascular or pulmonary disorder\n* Family history of known or suspected hereditary cardiovascular disease\n* Autoimmune disease or known family history of autoimmune disease\n* Any other condition that would contraindicate subject's participation in the clinical study due to safety concerns or compliance with clinical study procedures"}, 'identificationModule': {'nctId': 'NCT05187403', 'briefTitle': 'A Study of Laquinimod Eye-drops in Healthy Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Active Biotech AB'}, 'officialTitle': 'A Placebo-Controlled, Double-masked Phase-1 Study in Healthy Subjects Investigating the Safety and Tolerability of Laquinimod Eye Drops', 'orgStudyIdInfo': {'id': '21LAQ01'}, 'secondaryIdInfos': [{'id': '2021-004029-60', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Laquinimod - Single Ascending Doses', 'description': 'One single dose of laquinimod eye-drops. There are up to four planned dose levels.', 'interventionNames': ['Drug: Laquinimod']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo - Single Ascending Doses', 'description': 'One single dose of placebo eye-drops.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Laquinimod - Multiple Ascending Doses', 'description': 'Eye-drops administered once daily for 14-21 days. There are up to two planned dose levels. The first dose level will be defined in the SAD-part of the study.', 'interventionNames': ['Drug: Laquinimod']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo - Multiple Ascending Doses', 'description': 'Eye-drops administered once daily for 14-21 days.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Laquinimod', 'type': 'DRUG', 'otherNames': ['TV-5600', 'ABR-215062'], 'description': 'Eye-drops', 'armGroupLabels': ['Laquinimod - Multiple Ascending Doses', 'Laquinimod - Single Ascending Doses']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Eye-drops', 'armGroupLabels': ['Placebo - Multiple Ascending Doses', 'Placebo - Single Ascending Doses']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Vienna', 'country': 'Austria', 'facility': 'Clinical trial center at Medical University Vienna', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'overallOfficials': [{'name': 'Gerhard Garhöfer, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinical trial center at Medical University Vienna'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Active Biotech AB', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}