[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Sun Pharmaceutical Industries Limited\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":121},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,50,73,97],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":30,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100471748","phase-2-abiraterone-enzalutamide-or-apalutamide-in-castrate-sensitive-prostate-cancer-100471748",false,"NCT05422911","Abiraterone, Enzalutamide, or Apalutamide in Castrate-sensitive Prostate Cancer.","A Phase 2 Randomized Study of Abiraterone Acetate, Enzalutamide or Apalutamide as First Line Therapy in Veterans With Castrate-sensitive Prostate Cancer","Inclusion Criteria:\n\n* Veterans must meet the following to be eligible to participate:\n* Be willing and able to provide written informed consent for the trial.\n* Age ≥18 years of age on day of signing informed consent.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less (on a scale from 0 to 5, with higher scores indicating greater disability and a score of 5 indicating death).\n* Histologically or cytologically confirmed adenocarcinoma of the prostate without morphologic evidence of small-cell features in either a recently obtained sample or in the archival sample at the time of diagnosis.\n* Have previously begun within 120 days of randomization or will receive androgen-deprivation therapy with a gonadotropin releasing hormone agonist or antagonist or have undergone bilateral orchiectomy (i.e., medical, or surgical castration).\n* Laboratory tests meet minimum safety requirements:\n\n  * Hepatic: AST ≤2.5 X institutional ULN, ALT ≤2.5 X institutional ULN, Total bilirubin ≤1.5X upper limit of normal (ULN) \\[except for subjects with documented Gilbert's disease in which case total bilirubin not to exceed 10X ULN\\].\n  * Renal: Creatinine clearance ≥30 ml\u002Fmin or serum creatinine ≤1.8 mg\u002Fdl\n  * Hematological: Platelet count ≥100,000\u002Fmm\\^3; Hemoglobin \\>9 g\u002FdL; ANC \\>1 X10\\^9\u002FL\n  * Serum potassium \\>3 mEq\u002FL\n\nExclusion Criteria:\n\nSubjects with any of the following will not be enrolled:\n\n* Prior cytotoxic chemotherapy, aminoglutethimide, ketoconazole, abiraterone acetate, apalutamide or enzalutamide or darolutamide for the treatment of prostate cancer or participation in a clinical trial of an investigational agent that inhibits the androgen receptor or androgen synthesis (unless treatment was placebo).\n* Treatment with hormonal therapy (e.g., androgen receptor inhibitors other than bicalutamide, estrogens, 5-alpha reductase inhibitors) or biologic therapy for prostate cancer (other than approved bone-targeting agents and GnRH agonist\u002Fantagonist therapy) within 4 weeks of randomization.\n* History of seizure or any condition that may predispose to seizure (e.g., prior cortical stroke or significant brain trauma).\n* Patients who are receiving any other investigational agents concurrently.\n* Clinically significant heart disease as evidenced by New York Heart Association (NYHA) Class III-IV heart disease.\n* Child-Pugh Class B and C","MALE","18 Years",{"count":19,"type":20},192,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","The investigators have used national VHA data to demonstrate real-world efficacy of abiraterone and enzalutamide in Veterans with mCRPC. In the real-world that is the VHA, the investigators have successfully estimated g values that accurately predict OS and the use of this metric in other settings should now be explored. In the egalitarian system that is the VHA the treatment of prostate cancer is excellent and uniform across the US. The choices made are clearly personalized, given not all men received all therapies and that younger Veterans were treated more aggressively.\n\nBut with survivals that rival those in registration trials that enroll optimally fit individuals usually not encumbered by the co-morbidities that afflict many Veterans, the outcomes are testimony to the fact that for this common malady of older Veterans with whom VA physicians have broad experience the care administered is unsurpassed. Importantly this care at least as regards Veterans with mCRPC demonstrates that given equal access to health care, all men with prostate cancer fare comparably well. As our sophistication in categorizing cancers molecularly has increased this study will look to better examine any emerging differences across study participants.",[26,27,28,29],"Metastatic Cancer","Neoplasm, Prostate","Castrate-sensitive","Castrate-sensitive Prostate Cancer",[31,32,33,34,35,36],"YONSA","zytiga","enzalutamide","apalutamide","growth rate","doubling time","RECRUITING","2026-06-10",{"date":40,"type":41},"2026-06-15","ACTUAL",{"date":43,"type":41},"2022-08-31",{"date":45,"type":20},"2027-12-31",{"name":47,"class":48},"Sun Pharmaceutical Industries Limited","INDUSTRY",12,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":57,"minAge":17,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":21,"phases":60,"briefSummary":61,"conditions":62,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":72},"100614680","phase-2-efficacy-and-safety-of-gl0034-in-overweight-or-obese-adults-with-type-ii-diabetes-mellitus-100614680","NCT07282743","Efficacy and Safety of GL0034 in Overweight or Obese Adults With Type II Diabetes Mellitus","A Phase II, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Tolerability of GL0034 Among Type II Diabetes Mellitus Subjects Who Are Obese or Overweight With Weight-related Comorbidities","Inclusion Criteria:\n\n1. Participant is willing and able to sign a written ICF or e-ICF.\n2. Men or women ≥18 years of age at the time of signing ICF or e-ICF.\n3. Participant was diagnosed with type II diabetes mellitus at least 180 days prior to the day of screening.\n4. Participant has a HbA1c level of 7.0 - 10.5%, both inclusive, at the time of screening.\n5. Participant has a stable BMI ≥27 kg\u002Fm2 for at least 90 days prior to screening.\n6. Participant is able and willing to undergo fasting blood draw (i.e. at least 8 hours after last eating or drinking) as well as 7-point SMBG check for 3 consecutive days prior to designated scheduled visits by using a home glucometer that is provided by the study site.\n7. Participant on stable daily doses of metformin for at least 90 days prior to screening.\n8. Participant who are on metformin and not the following agents for at least 3 months prior to screening: DPP-4 inhibitors, alpha-glucosidase enzyme inhibitors, sulfonylureas, sodium-glucose transport 2 inhibitors, amylin analogues, thiazolidinediones, any insulin product, herbals, or ayurvedic agents. Participants are encouraged to follow the standard of care in their study regions, including appropriate diet and lifestyle modifications, rather than make abrupt change in the diabetic management prior to screening without consulting their physicians.\n9. If participant is a woman of childbearing potential (WOCP)\\*, she must agree to use a highly effective method of contraception during the study in conjunction with a barrier method of contraception, and continue the same contraception method at least one months after the last dose of study drug. Highly effective methods of contraception include one of the following: intrauterine device, injectable hormonal contraceptive, contraceptive patch or implant, partner's vasectomy, bilateral tubal occlusion, and sexual abstinence.\n\n   \\*WOCP includes women who are not surgically sterilized \\[using hysterectomy\u002Fbilateral salpingectomy\u002Fbilateral oophorectomy\\] or post-menopausal \\[defined as 12 consecutive months of amenorrhea without an alternative medical cause\\].\n10. Male participants with female partners of child-bearing potential must use a barrier method of contraception (e.g., condom) if not surgically sterile (i.e., vasectomy) during the study. In addition, male participants agree to use the same method of contraception for an additional 30 days after the last IP dose and refrain from donating sperm during this period. In the event that the female partner of the male participant becomes pregnant during the study period + 30 days after the last IP dose, an ICF will be provided to the female partner in order to monitor the female partner, pregnancy, and the newborn.\n11. If participant is a WOCP, she must have a negative serum pregnancy test (SPT) at Screening and a negative urine pregnancy at baseline, with results available before IP administration.\n12. Participant is willing and able to comply with the study protocol, visit schedule, and other study-related instructions and procedures.\n13. Participant is willing and able to independently record the response on various scales and make entries using the e-Patient reported outcomes (ePRO) device.\n\nExclusion Criteria:\n\n1. Participants who have a history of type I diabetes mellitus.\n2. A self-reported change in \\>5% of body weight within 90 days before screening irrespective of medical records.\n3. History of pancreatitis (acute or chronic) or \\>3 hypoglycemic episodes (blood glucose level \\\u003C70 mg\u002FdL or 3.9 mmol\u002FL) within 90 days prior to screening.\n4. Diagnosis of chronic kidney disease with estimated glomerular filtration rate \\\u003C60.\n5. Poorly controlled hypertension with systolic blood pressure \\>160 mmHg and\u002For diastolic blood pressure \\>100 mmHg.\n6. Poorly controlled hypothyroidism defined as thyroid-stimulating hormone \\>6 mIU\u002FL or \\\u003C0.4 mIU\u002FL.\n7. Diabetes mellitus and\u002For obesity that is induced by endocrine disorders (e.g. Cushing Syndrome) or medication use (e.g. corticosteroids) as judged by the Investigator.\n8. Previous surgical treatment for obesity (liposuction and\u002For abdominoplasty performed \\>1 year before screening is allowed). Previous or planned (during the trial period) obesity treatment with surgery or a weight loss device. However, previous interventions that, due to reversal or removal, does not have any influence on the participant's weight, in the opinion of the Investigator, are allowed.\n9. History of major depressive disorder within 2 years before randomization.\n10. History of other severe psychiatric illnesses (i.e. schizophrenia, bipolar disorder).\n11. Any lifetime history of a suicidal attempt.\n12. Participants with any medical condition \\[i.e. gastroparesis, uncontrolled gastroesophageal reflux disease, or diarrhea with or without a diagnosis of a diagnosis of irritable bowel syndrome\\] that, in the opinion of the Investigator, can confound study efficacy assessments or safety concerns.\n13. Participant had a myocardial infarction, unstable angina pectoris, or ischemic stroke within the past 6 months prior to IP administration.\n14. Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2, sudden cardiac death, unexplained death, long QT syndrome, or death from a primary dysrhythmia potentially associated with QT prolongation in any family member.\n15. Surgery scheduled for the trial duration period, except for very minor surgical procedures in the opinion of the Investigator.\n16. Participants with active malignancy.\n\n    Note: participants with past history of malignancy may be included if:\n    * Participant has history of basal cell or in-situ squamous cell carcinoma of skin that has been adequately treated and resolved, per Investigator's judgement.\n    * Participant has history of other malignancy that have been adequately treated with no evidence of recurrence\u002Frelapse within the last 5 years, per Investigator's judgement.\n17. Presence of diabetic retinopathy \\[both nonproliferative diabetic retinopathy and proliferative diabetic retinopathy\\]) or maculopathy in either eye that was verified by a fundoscopic examination within 90 days prior to screening or during the study.\n18. Known moderate to severe coronary, carotid, or peripheral vascular disease that has planned or will likely need revascularization during the study.\n19. Participants with any other condition, which in the opinion of the Investigator, precludes participation in the study (either poses an unacceptable risk to the participant or interferes with assessment\u002Finterpretation of study outcomes).\n20. Known hypersensitivity to the study IP or its excipients.\n21. History of alcohol or drug abuse in the previous two years (Alcohol abuse in this study is defined as \\>14 standard drinks per week in men or \\>7 standard drinks per week in women ± a history of alcohol withdrawal symptoms ± institutionalized\u002Fhospitalized due to alcohol use ± binge drinking with \\>5 standard drinks on a single occasion in men or \\>4 standard drinks on a single occasion in women).\n22. Participants are taking, or will start, medications with narrow therapeutic index such as digoxin, warfarin, etc, or those that will prolong QTc interval.\n23. Participants received any medications for the treatment of type II diabetes mellitus other than those stated in the inclusion criteria within 90 days before screening. Short-term insulin treatment for a maximum of 7 days prior to screening is allowed. Prior insulin treatment for gestational diabetes is also allowed.\n24. Participants who have used medications in the family of GLP-1 agonists in the past.\n25. Treatment with any herbal diet supplements, over-the-counter diet medications as an attempt to lose weight within 90 days before screening.\n26. Treatment with orlistat, lorcaserin, zonisamide, topiramate, phentermine, buproprion, or naltrexone that could promote weight loss within 90 days before screening.\n27. Participation in any organized or online weight-reduction program (i.e. Weight Watchers) within 90 days before screening.\n28. Screening calcitonin ≥50 ng\u002FL (pg\u002FmL).\n29. Participants having clinically significant abnormal values on Screening laboratory tests or other evidence of uncontrolled disease involving any system-organ (e.g., cardiovascular, pulmonary, renal, hepatic, neurological, endocrine, gastrointestinal, psychiatric etc.) that, in the opinion of the Investigator, would put the participant at risk by participating in the study.\n30. Participants with positive urine drug screen \\[amphetamine, barbiturate, benzodiazepine, cocaine, opiates\\] with substances that are not part of participant's routine medical care. Tetrahydrocannabinols is acceptable for as long as its use is legally allowed by participant 's home state or country.\n31. Participants have clinically significant ECG abnormality , including QTcF \\>450 msec for males and \\>470 msec for females, or at high risk for arrhythmia such as judged by the Investigator conditions listed in Criteria #13 above, brady-arrhythmias, tachy-arrhythmias, ventricular arrhythmias, torsade de pointes, high-degree atrioventricular block, or New York Heart Association Class III and IV congestive heart failure.\n32. Pregnant or lactating females.","ALL",{"count":59,"type":20},285,[23],"This is a phase II, randomized, double-blind, placebo-controlled study to evaluate the efficacy and tolerability of GL0034 among type II diabetes mellitus subjects who are obese or overweight with weight-related comorbidities. Subjects will be put on either one of the four treatment arms (GL0034, once a week, subcutaneous injection) or placebo arm (once a week, subcutaneous injection) following initial dose-up titration that takes up to approximately 20 weeks. The primary end point is change in HbA1c levels from baseline (Week 0) to Week 36 following treatments in all participants.",[63],"Type II Diabetes Mellitus","2026-03-17",{"date":66,"type":41},"2026-03-18",{"date":68,"type":41},"2026-01-20",{"date":70,"type":20},"2027-08",{"name":47,"class":48},21,{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":80,"sex":57,"minAge":17,"maxAge":81,"enrollmentInfo":82,"targetDuration":4,"studyType":21,"phases":84,"briefSummary":86,"conditions":87,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},"100622586","phase-1-study-to-evaluate-if-exposure-to-drug-is-impacted-in-participants-with-renal-insufficiency-100622586","NCT07385547","Study to Evaluate if Exposure to Drug is Impacted in Participants With Renal Insufficiency","A Phase 1 Study to Assess the Effect of Renal Impairment on the Pharmacokinetics of GL0034","Inclusion Criteria:\n\n1. Participant is willing and able to sign a written or electronic informed consent.\n2. Participant is an adult male or female, aged between 18 and 80 years of age, inclusive, at the time of screening.\n3. Participant has eGFR as defined by CKD-EPI equation and converted to the unit of mL\u002Fmin according to the following ranges:\n\n   * eGFR ≥ 90 mL\u002Fmin;\n   * eGFR ≥ 30-59 mL\u002Fmin;\n   * eGFR \\\u003C 30 mL\u002Fmin, not on dialysis;\n   * eGFR \\\u003C 30 mL\u002Fmin, on intermittent hemodialysis.\n4. Participant has a body mass index ≥ 18 kg\u002Fm2 and ≤ 42 kg\u002Fm2 at the Screening visit.\n5. Contraception requirements:\n\n   Female participants must:\n\n   If of reproductive age and sexually active, be willing and able to use a medically highly effective form of birth control 4 weeks prior to and for 30 days following the dose of trial medication. Examples of medically highly effective forms of birth control are:\n   1. Confirmed infertility due to surgical procedure or post-menopausal (cessation of menses for at least 12 months prior to Screening).\n   2. Confirmed infertility of sexual partner or partner of the same sex.\n   3. Hormonal contraceptive (oral, combined, patch, vaginal ring, injectable, implant) in females.\n   4. Double-barrier method (any combination of physical and chemical methods).\n   5. Intrauterine device with a failure rate less than 1% per year.\n\n      Male participants must:\n   6. Agree to use, with their partners, one of the highly effective contraceptive methods, from Baseline until at least 30 days following last dose of trial drug.\n   7. Refrain from donating sperm during the trial and for at least 30 days after the end of the trial.\n6. Participant is willing and able to comply with the study protocol, visit schedule, and other study-related instructions and procedures.\n\n   Participants with Renal Impairment\n7. The participant must have no clinically significant change in disease status within the last 30 days before screening, as documented by the participant's recent medical history.\n8. The participant must have a condition consistent with renal impairment, for at least 3 months, and associated symptoms, but otherwise be determined to be in good health in the opinion of the Investigator.\n9. The participant must have blood pressure (after the participant is supine for at least 5 minutes) between 90 and 160 mmHg systolic, inclusive, and not higher than 110 mmHg diastolic. If blood pressure is out of range, up to 2 repeated assessments are permitted at Screening and check-in. Pulse should not be higher than 110 beats per minute (bpm).\n10. Concomitant medications to treat underlying disease states or medical conditions related to renal impairment are allowed, however must be on a stable dose of medication and\u002For treatment regimen for at least 4 weeks before dosing as well as during the study.\n\nExclusion Criteria:\n\n1. Participant has a screening calcitonin ≥ 50 ng\u002FL (pg\u002FmL).\n2. Participant is on continuous renal replacement therapy or peritoneal dialysis.\n3. Participant has a personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome (MENS) type 2.\n4. Participant has a history of pancreatitis (acute or chronic).\n5. Participant is taking medications with a narrow therapeutic index such as digoxin, warfarin, etc.\n6. Participant has a history of major depressive disorder within 2 years before randomization.\n7. Participant has any lifetime history of a suicidal attempt.\n8. Participant has any medical condition that, in the opinion of the Investigator, can confound study assessments or safety concerns.\n9. Participant has a known hypersensitivity to the study medications or excipients.\n10. Participant has clinically significant abnormal values on Screening laboratory tests or other evidence of uncontrolled disease involving any system-organ (e.g., cardiovascular, pulmonary, hepatic, neurological, endocrine, GI, psychiatric, etc.) that, in the opinion of the Investigator, would put the participant at risk by participating in the study.\n11. Participant has a positive urine drug screen (amphetamine, barbiturate, benzodiazepine, cocaine, opiates, tetrahydrocannabinols). A positive test is allowed in case the participant receives a prescription drug responsible for the positive test. Waived for ESRD participants with no urine output.\n12. Participant had a myocardial infarction, unstable angina pectoris, or ischemic stroke within the past 6 months prior to investigational product administration.\n13. Participant has a clinically significant ECG abnormality as judged by the Investigator.\n14. Participant has an active malignancy.\n\n    Note: participants with past history of malignancy may be included if:\n    * Participant has a history of basal cell or in-situ squamous cell carcinoma of skin that has been adequately treated and resolved, per Investigator's judgement.\n    * Participant has a history of other malignancy that have been adequately treated with no evidence of recurrence\u002Frelapse within the last 5 years, per Investigator's judgement.\n15. Participant has a history of alcohol or drug abuse in the previous two years.\n16. Participant has any of the following laboratory abnormalities at Screening:\n\n    * Aspartate aminotransferase or alanine aminotransferase ≥ 3 times the upper limit of normal.\n    * Serum total bilirubin ≥ 1.5 mg\u002FdL (Note: participants with elevated total bilirubin which, as per Investigator's clinical judgement, is thought to be due to Gilbert's syndrome may be included).\n    * White blood cell count \\\u003C 3.0 x 103\u002FμL.\n    * International normalized ratio (INR) ≥ 1.3.\n    * Hemoglobin \\\u003C 11.0 g\u002FdL in participants with normal renal function or hemoglobin \\\u003C 9.0 g\u002FdL in participants with moderate or severe renal impairment.\n17. Participant has a known history of coagulopathy such that SC injection will result in excessive bleeding at the injection sites.\n18. Participant has a positive serology for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C. A participant who is hepatitis C virus (HCV) antibody negative can be included in the study. A participant with positive HCV antibodies shall be tested for HCV-ribonucleic acid (RNA). If tested negative, the participant can be included in the study.\n19. Participant participated in another interventional study or received another investigational drug\u002Fdevice\u002Fbiologic within 30 days or 5 half-lives (whichever is longer) of study intervention.\n20. Participant has been placed in an institution on official or judicial orders.\n21. Participant is related to or dependent on the Investigator, Sponsor, or study site such that a conflict of interest may arise.\n22. Participant has any condition, which, in the opinion of the Investigator, precludes participation in the study (either poses an unacceptable risk to the participant or interferes with assessment\u002Finterpretation of study outcomes).",true,"80 Years",{"count":83,"type":20},40,[85],"PHASE1","This is an open-label, single-dose, Phase 1 clinical study designed to evaluate the effect of renal impairment on the pharmacokinetics (PK) of GL0034, a long-acting GLP-1 receptor agonist. Approximately 40 adult participants will be enrolled across four groups: normal renal function, moderate renal impairment, severe renal impairment without dialysis, and severe renal impairment with dialysis. Each participant will receive a single subcutaneous dose of GL0034. Blood samples will be collected for PK analysis. Secondary objectives include assessing safety and tolerability. The study will help determine whether renal impairment affects GL0034 exposure and inform dosing recommendations for patients with compromised renal function.",[63],"2026-03-11",{"date":90,"type":41},"2026-03-13",{"date":92,"type":41},"2026-02-25",{"date":94,"type":20},"2026-09-27",{"name":47,"class":48},3,{"id":98,"slug":99,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":4,"eligibilityCriteria":103,"healthyVolunteers":11,"sex":104,"minAge":4,"maxAge":4,"enrollmentInfo":105,"targetDuration":107,"studyType":108,"phases":4,"briefSummary":109,"conditions":110,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},"100361943","safety-study-for-prospective-assessment-of-pregnancy-outcomes-in-patients-treated-with-tildrakizumab-100361943","NCT03992729","Safety Study for Prospective Assessment of Pregnancy Outcomes in Patients Treated With Tildrakizumab","Post-authorization Safety Study for Assessment of Pregnancy Outcomes in Patients Treated With Tildrakizumab","Cohort 1: Tildrakizumab-Exposed Cohort\n\n1. Pregnant women\n2. Exposure to tildrakizumab for the treatment of an approved indication, for any number of days, at any dose, and at any time from the first day of the last menstrual period up to and including the end of pregnancy\n3. Agree to the conditions and requirements of the study including the interview schedule, and release of medical records\n\nCohort 2: Disease-Matched Comparison Cohort\n\n1. Pregnant women\n2. Diagnosed with a tildrakizumab-approved indication; frequency matched to the exposed group by disease indication, with the indication validated by medical records when possible\n3. No exposure to tildrakizumab at any time in the current pregnancy; may or may not have taken another medication for their disease in the current pregnancy\n4. Agree to the conditions and requirements of the study including the interview schedule, and release of medical records\n\nExclusion criteria:\n\nCohort 1: Tildrakizumab-Exposed Cohort:\n\n1. Women who have first contact with the project after prenatal diagnosis of any major structural defect\n2. Women who have enrolled in the tildrakizumab cohort study with a previous pregnancy (women may only enroll once in the Tildrakizumab Pregnancy Study)\n3. Women who have used tildrakizumab for an indication other than a currently approved indication\n4. Retrospective enrollment after the outcome of pregnancy is known\n\nCohort 2: Disease-Matched Comparison Cohort\n\n1. Women who have first contact with the project after prenatal diagnosis of any major structural defect\n2. Exposure to tildrakizumab anytime during the current pregnancy\n3. Women who have enrolled in the tildrakizumab cohort study with a previous pregnancy (women may only enroll once in the Tildrakizumab Pregnancy Study)\n4. Retrospective enrollment after the outcome of pregnancy is known","FEMALE",{"count":106,"type":20},200,"20 Months","OBSERVATIONAL","This study will utilize a prospective, observational, exposure cohort design to examine pregnancy and infant outcomes in women and infants who are exposed to tildrakizumab during pregnancy to treat an approved indication.\n\nThe pregnancy registry cohort study will be conducted by the Organization of Teratology Information Specialists (OTIS), which is a network of university and health department based information centers serving pregnant women and healthcare providers throughout North America. These services provide a basis for collaborative research such as this Registry.\n\nThese Services located throughout the United States (US) and Canada will serve as a source of referrals not only for tildrakizumab-exposed pregnancies but also for similarly ascertained disease-matched comparison pregnant women who have not used tildrakizumab in pregnancy.\n\nThe target follow-up period will be until end of pregnancy and 1 year of age for live born infants.",[111],"Pregnancy Related","2026-01-19",{"date":114,"type":41},"2026-01-21",{"date":116,"type":41},"2019-08-29",{"date":118,"type":20},"2028-07-31",{"name":47,"class":48},1,""]