Sanmenxia

Researchers are evaluating the safety and effectiveness of MC2-01 cream in treating Chinese adults aged 18 years and older with plaque psoriasis affecting the body (trunk and/or limbs). This phase 3, multi-center, randomized, investigator-blinded study compares MC2-01 cream to both calcipotriol and betamethasone dipropionate gel and a vehicle cream. The study includes screening, treatment, and safety follow-up periods to thoroughly assess the treatment's impact. Participants receive one of three treatments: MC2-01 cream (containing calcipotriene and betamethasone dipropionate), CAL/BDP gel (calcipotriol and betamethasone dipropionate gel), or a vehicle cream without active ingredients. Treatments are applied during the treatment period following the study protocol. The design allows comparison of MC2-01 cream’s efficacy and safety against the gel and vehicle. During the study, participants undergo evaluations including physician assessments using the Physician's Global Assessment (PGA) to measure treatment success on the body after 8 weeks. Researchers monitor safety and treatment response through scheduled visits covering screening, treatment, and follow-up phases. Participation involves completing visits as required by the protocol to ensure comprehensive data collection over the study duration.

Researchers are evaluating the effectiveness of JNJ-95597528 compared to a placebo in adults with moderate to severe atopic dermatitis, a chronic skin condition. This Phase 2b study aims to assess how well JNJ-95597528 works in improving symptoms in participants who have had the condition for at least one year and meet specific disease severity criteria. JNJ-95597528 and placebo will both be given by subcutaneous injection. The study is randomized, double-blind, and placebo-controlled to ensure reliable results. Participants will receive their assigned treatment and be monitored throughout the study to evaluate the drug's impact on their skin condition. Participants will be involved in scheduled visits where their eczema severity will be assessed using the Eczema Area and Severity Index (EASI) among other measures. The primary outcome is the proportion of participants achieving a 75% improvement in EASI at Week 12. Safety and adherence to the treatment plan will also be monitored during the study period.

Researchers are evaluating the efficacy and safety of Antiwei granules for treating the common cold, specifically the wind-cold syndrome type. This is a multicenter, randomized, double-blind, placebo-controlled Phase 3 clinical trial designed to assess how well Antiwei granules work and how safe they are for adults aged 18 to 65 who have had a recent onset of the common cold. Participants will be randomly assigned to receive either Antiwei granules or a placebo. Both groups will take oral doses of 1 sack (6g) three times daily for a total of 9 sacks over a 3-day treatment period. The study compares the effects of the active granules versus placebo on cold symptoms. During the trial, participants will be monitored closely with assessments focusing on the cure rate after 3 days of treatment. Researchers will track symptoms and safety throughout the short treatment period. The total study duration for each participant is about 3 days, during which the effectiveness and any side effects of the treatment will be recorded and analyzed.

Researchers are evaluating the use of tenecteplase compared to standard medical care for adults who have had an acute ischemic stroke caused by blockages in medium-sized brain arteries. This Phase 3 trial focuses on patients whose stroke symptoms began between 4.5 and 24 hours prior to treatment and who meet specific imaging and clinical criteria. The study aims to better understand the safety and effectiveness of tenecteplase in this particular group, as previous trials have shown limited benefit from thrombectomy for such cases. Participants will be randomly assigned to receive either tenecteplase at a dose of 0.25 mg per kilogram of body weight (up to 25 mg) as a single intravenous bolus or standard medical treatment, which may include aspirin and/or clopidogrel. Eligibility is determined using brain imaging techniques such as CT angiography or MRI to confirm the location and extent of the vessel blockage and to assess tissue at risk. The treatment is administered within 4.5 to 24 hours after the patient was last seen well, including wake-up and unwitnessed strokes. During the 90-day study period, researchers will assess participants' recovery using the modified Rankin Scale (mRS), focusing on the proportion achieving a score of 1 or less, indicating minimal or no disability. Participants will undergo neurological assessments, imaging studies, and clinical evaluations. Safety and adherence to the treatment protocol will be closely monitored. The trial also includes follow-up to observe long-term outcomes and any adverse effects related to the treatments.

Researchers are evaluating the long-term safety and effectiveness of drug-coated balloon (DCB) strategies compared to drug-eluting stent (DES) only treatment in patients with chronic total occlusion (CTO) of the coronary arteries after successful reopening of the artery. This study aims to provide high-quality evidence by directly comparing DCB alone or combined with DES (hybrid strategy) against DES-only treatment. The goal is to improve treatment strategies, reduce the use of stents, lower complication risks, and enhance patient outcomes for these complex heart artery blockages. The trial involves two groups: one receiving DCB angioplasty with possible provisional DES implantation if necessary, and the other receiving standard DES implantation. Both treatments use devices sized to the vessel diameter and cover the blocked segment plus surrounding healthy areas. DCB balloons are inflated to deliver medication, while stents are deployed with appropriate pressure to ensure vessel support. All patients receive standard medical therapy including at least 12 months of dual antiplatelet therapy and are followed for 36 months after the procedure. Participants will undergo assessments including angiographic imaging to measure late lumen loss at 9 months by a blinded core lab, as well as monitoring for clinical outcomes such as cardiac events, repeat procedures, and quality of life. An independent committee adjudicates clinical events. The study uses intention-to-treat analysis to compare safety and efficacy between groups. This comprehensive follow-up and evaluation plan aims to provide valuable insights into optimizing CTO treatment.

Stroke is the second leading cause of death worldwide, with ischemic stroke being the most common type. The current best treatment for acute ischemic stroke is intravenous thrombolysis using recombinant tissue plasminogen activator (rt-PA) given within 4.5 hours of symptom onset. However, some patients experience stroke progression or early blood vessel reocclusion after thrombolysis, which worsens neurological function and outcomes. This is believed to be caused by increased platelet activation after thrombolysis, which peaks within the first 2 hours. This clinical trial is testing whether starting oral aspirin early after intravenous thrombolysis can improve functional outcomes without causing more bleeding problems. Patients are randomly assigned to receive either 300 mg aspirin tablets or matching placebo tablets as soon as possible after enrollment. If swallowing is difficult, tablets can be crushed and given through a nasogastric tube. Both groups receive best medical management according to guidelines. The study is a Phase 3, multicenter, randomized, placebo-controlled trial. Participants will be followed for 90 days after stroke to measure their functional recovery using the modified Rankin scale (mRS). Researchers will check if patients have a good outcome defined as an mRS score of 0 or 1 at 90 days. During the study, patients undergo assessments including neurological exams and imaging to confirm eligibility and monitor safety. The trial aims to determine if early aspirin treatment after thrombolysis is safe and can help prevent neurological decline and improve recovery.

Researchers are investigating the effectiveness and safety of oral minocycline compared to placebo in patients who have experienced an acute spontaneous intracerebral hemorrhage within 48 hours of symptom onset. This phase III clinical trial is designed as a prospective, multicenter, randomized, double-blind, placebo-controlled study aiming to improve recovery outcomes in this patient population. An additional goal is to assess the impact of minocycline on markers of venous neuroinflammation at various times after the hemorrhage. A total of 1192 participants will be randomly assigned in equal numbers to receive either minocycline capsules containing 50 mg of minocycline hydrochloride or matching placebo capsules for five days. All participants will also receive standard medical care based on current guidelines. The study includes three phases: screening and baseline, treatment, and follow-up. Participants will be evaluated at several time points including screening/baseline, 72 ±12 hours, 7 ±1 days, 90 ±7 days, and 180 ±7 days after randomization, as well as during any relevant events. Researchers will measure the primary outcome of disability and functional status using the modified Rankin Scale score (mRS) at 90 days post-randomization, aiming for scores between 0 and 3. Throughout the study, assessments and interviews will monitor safety, efficacy, and treatment adherence.

Researchers are evaluating the effectiveness, safety, and pharmacokinetics of roflumilast cream 0.3% for treating plaque psoriasis in Chinese individuals aged 6 years and older. This is a phase III, multicenter, randomized, double-blind study comparing roflumilast cream to a vehicle cream. Participants must have a clinical diagnosis of plaque psoriasis with a certain severity and stable disease for a defined period. Participants will be randomly assigned to receive either roflumilast cream 0.3% or vehicle cream. The treatment duration is 8 weeks, during which participants will apply the assigned cream as directed. The study excludes those who have recently used certain systemic or topical psoriasis treatments or biologics, and those with other skin conditions that could interfere with the assessment. During the study, participants will undergo assessments including clinical evaluations of psoriasis severity using Investigator Global Assessment (IGA) scores and Psoriasis Area and Severity Index (PASI) scores. Safety will be monitored through medical history, physical exams, laboratory tests, and pregnancy tests for females of childbearing potential. The primary outcome is the proportion of participants achieving treatment success based on IGA scores after 8 weeks. Participants will be followed throughout the study to monitor treatment effects and safety.

This research aims to evaluate the effectiveness, safety, and pharmacokinetic properties of ICP-488 in Chinese adults with moderate to severe plaque psoriasis. The study is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical trial designed to compare oral ICP-488 to a placebo in this patient population. Participants will be randomly assigned to receive either ICP-488 tablets or a placebo, both taken orally according to the study protocol. The treatment period lasts for 16 weeks, during which the effects of the drug on plaque psoriasis symptoms will be closely monitored. During the study, participants will undergo assessments to measure improvements using the static Physician's Global Assessment (sPGA) and Psoriasis Area and Severity Index (PASI) scores at week 16. Researchers will track the proportion of subjects achieving clear or almost clear skin with significant improvement, as well as those reaching a 75% reduction in PASI score. Safety and pharmacokinetics will also be evaluated throughout the study duration.

Researchers are conducting a randomized, double-blind, placebo-controlled Phase III study to evaluate the effectiveness and safety of oral ICP-332 in adults with moderate to severe atopic dermatitis, also known as atopic eczema. The study focuses on people aged 18 to 75 who have had this condition for at least one year and have shown inadequate response to topical treatments. Participants will receive either ICP-332 tablets or placebo tablets. The treatment aims to reduce symptoms of atopic dermatitis, including skin inflammation and itching. The study measures the proportion of participants who achieve at least a 75% reduction in the Eczema Area and Severity Index (EASI 75) and those who reach a low score on the Investigator Global Assessment for Atopic Dermatitis after 16 weeks of treatment. During the study, participants will attend scheduled visits for assessments including skin evaluations and symptom scoring. Researchers will monitor treatment adherence, safety, and response through laboratory tests and clinical examinations. The total participation duration includes the 16-week treatment period where outcomes are closely observed to assess the impact of ICP-332 compared to placebo.