[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"SFA Therapeutics\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":73},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":4},"100582452","phase-2-comparison-of-otezla-to-sfa-002-to-placebo-in-plaque-psoriasis-patients-100582452",false,"NCT06863493","Comparison of Otezla to SFA-002 to Placebo in Plaque Psoriasis Patients","Study of the Safety and Effectiveness of Oral SFA-002 Compared to Oral Apremilast (Otezla) Tablets and Placebo in Mild to Severe Plaque Psoriasis","Inclusion Criteria:-\n\n1. Candidates for systemic therapy with mild to moderate chronic plaque psoriasis (PsO) (with or without psoriatic arthritis) at Screening and Baseline for at least 6 months prior to Baseline defined as:\n2. Body Surface Area (BSA) \\>= 10% and \\\u003C= 15%; and Psoriasis Area and Severity Index (PASI) \\>= 12; and Static Physician Global Assessment (sPGA) = 3 (moderate) based on a 5-point scale (0 to 4) -\n\nExclusion Criteria:\n\n1. Participant has any form of PsO other than chronic plaque PsO (e.g., pustular PsO, palmoplantar pustulosis, acrodermatitis of Hallopeau, erythrodermic, or guttate PsO).\n2. History of current drug-induced PsO or a drug-induced exacerbation of pre-existing psoriasis.\n3. History of active ongoing inflammatory skin diseases other than PsO and psoriatic arthritis that could interfere with the assessment of PsO (e.g., hyperkeratotic eczema).\n4. Prior exposure to SFA002 or apremilast. -","ALL","18 Years","85 Years",{"count":20,"type":21},125,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE2","PHASE3","The goal of this clinical trial\\] is to learn if SFA002 can treat mild, moderate and severe plaque psoriasis as good or better than Otezla, compared to placebo in adult and pediatric patients.\n\nThe main questions it aims to answer are:\n\nHow much does oral SFA002 treatment improve plaque psoriasis measured at different timepoints, 12 weeks, 24 weeks and 52 weeks of treatment.\n\nHow much does Oral Otezla (Apremilast) improve plaque psoriasis measured at different timepoints, 12 weeks, 24 weeks and 52 weeks of treatment.\n\nThese treatments will be compared to placebo, a look-alike substance that contains no drug.\n\nParticipants will be randomly placed into 3 groups to receive either SFA002, or oral apremilast or placebo for the duration of the trial. Patients that do not respond to apremilast or placebo treatment in 12 weeks will be offered the opportunity to take SFA002 for the remainder of the study.\n\nThere may be a higher burden for participants in this study compared to usual standard of care. Participants will attend regular visits per routine clinical practice. The effect of the treatment will be checked by medical assessments, checking for side effects, and questionnaires.",[28],"Psoriasis (PsO)",[30,31,32],"Otezla","apremilast","Mild psoriasis","NOT_YET_RECRUITING","2025-03-06",{"date":36,"type":37},"2025-03-11","ACTUAL",{"date":39,"type":21},"2025-06-01",{"date":41,"type":21},"2026-09-01",{"name":43,"class":44},"SFA Therapeutics","INDUSTRY",{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":72},"100488597","phase-1-study-of-sfa002-in-patients-with-mild-to-moderate-psoriasis-plaques-100488597","NCT05642182","Study of SFA002 in Patients with Mild to Moderate Psoriasis Plaques","A Study of Improvement in Psoriasis Symptoms Associated with Combinations of Biologically Active Natural Substances (SFA-002) with Known Safety Profile","Inclusion Criteria:\n\n* Subjects of both sexes ≥18 years of age with at least one skin plaque that is \\>5 cm2 due to known psoriasis considered clinically to be MILD to MODERATE or MODERATE to SEVERE during evaluation and diagnosis at least 1 year prior. Mild is defined as \"Just detectable to mild thickening; pink to light red coloration; predominantly fine scaling\", whereas moderate is defined as \"Clearly distinguishable to moderate thickening; dull to bright red, clearly distinguishable to moderate thickening; moderate scaling\".\n* Have or have not been treated with phototherapy, systemic therapy, or other therapies for their psoriasis\n* Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must use effective contraceptive methods (such as abstinence, intrauterine device (IUD), or double barrier device) during the study and for at least 3 months following completion of the study.\n* Mentally competent, able to understand and willingness to sign the Informed Consent Form (ICF).\n* Able to undergo the investigations and to follow the visit schedule stated in the study protocol.\n\nExclusion Criteria:\n\n* The forms of psoriasis other than chronic plaque psoriasis (such as drug-induced psoriasis or guttate, erythrodermic, or pustular psoriasis) or if the psoriasis does not meet the criterion of chronicity (defined as a clinically significant flare of psoriasis within 12 weeks before baseline).\n* Presence of other form of inflammatory skin diseases (such as atopic dermatitis) or infectious diseases (such as cellulitis, warts, fungal cutaneous diseases, etc.)\n* A clinically significant flare of psoriasis within 12 weeks before baseline. (Note: The determination of whether prospective study participants had a \"significant flare\" prior to study baseline is left to the investigators. The intent of this criterion was to ensure the condition is sufficiently stable and aligned with the chronic nature of plaque psoriasis, so that an adequate assessment of the efficacy could be made.)\n* Prior or current use of psoriasis medications that might confound assessment of efficacy of the investigational supplements used in this study, unless there were used before their washout period prior to study initiation (see Table 2 for specific medications and their washout periods).\n* Known serious medical illness, such as significant cardiac disease (e.g., symptomatic congestive heart failure, unstable angina pectoris, symptomatic coronary artery disease, myocardial infarction within the past 6 months, uncontrolled or symptomatic cardiac arrhythmia, or New York Heart Association Class III or IV), or severe debilitating pulmonary disease, that would potentially increase subjects' risk for toxicity.\n* Known to have a history of risk factors for torsade de pointes (e.g., clinically significant heart failure, hypokalemia, family history of Long QT Syndrome).\n* Known to have arterial thrombotic event, stroke, or transient ischemia attack within the past 12 months.\n* Known to have uncontrolled hypertension (systolic blood pressure \\>160 mm Hg or diastolic blood pressure \\>90 mm Hg), or peripheral vascular disease ≥grade 2.\n* Known to have active central nervous system (CNS), epidural tumor or metastasis, or brain metastasis.\n* Any active uncontrolled bleeding, a bleeding diathesis (e.g., active peptic ulcer disease), or a history of bleeding (e.g., hemoptysis, upper or lower gastrointestinal \\[GI\\] bleeding) within the past 6 months.\n* Dyspnea with minimal to moderate exertion; large and recurrent pleural or peritoneal effusions requiring frequent drainage (e.g. weekly); or any amount of clinically significant pericardial effusion.\n* Diabetes of any type, except Non-Insulin Dependent Diabetes Mellitus (NIDDM) that is controlled and with hemoglobin A1c 8%.\n* Evidence of active infection during screening, or serious infection within the past month.\n* Patients with known Human Immunodeficiency Virus (HIV), hepatitis B or C virus (HBV) or (HCV), respectively), or active or latent Tuberculosis (TB).\n* Serious or non-healing wound, skin ulcer, or bone fracture.\n* Abdominal fistula, GI perforation, or intra-abdominal abscess within the past 6 months.\n* Neuropathy of grade ≥2.\n* Pregnant or lactating females.\n* Patients like to purposely undergoing sunlight exposure, including the skin area where the plaques being investigated are located, during the study",{"count":53,"type":21},90,[55],"PHASE1","The purpose of this study is to determine the safety, metabolism and potential effect of drug product SFA-002 on mild moderate and severe chronic plaque psoriasis. Psoriasis is a common chronic skin disorder that affects over 4 million people. There is no cure for psoriasis and treatment is directed at controlling patients' symptoms.",[58],"Psoriasis",[60,61,62],"Mild Plaques psoriais","moderate Plaque Psoriasis","Severe plaque psoriasis","RECRUITING","2025-01-07",{"date":66,"type":37},"2025-01-09",{"date":68,"type":37},"2022-03-31",{"date":70,"type":21},"2025-07-31",{"name":43,"class":44},3,""]