Coorparoo

Researchers are evaluating the safety and effectiveness of different doses of ZL-1102 topical gel, a human VH IL-17A antibody fragment, in adults with chronic plaque psoriasis. This phase 2, randomized, double-blind, vehicle-controlled, dose-ranging study involves about 250 patients with plaque psoriasis affecting 3% to 15% of their body surface area, excluding the head. The study aims to compare various doses of ZL-1102 gel to a placebo gel over a 16-week treatment period. Participants are randomly assigned to one of five groups receiving different doses and frequencies of ZL-1102 gel or placebo gel. The treatment arms include ZL-1102 1% gel applied twice daily, ZL-1102 3% gel applied either once or twice daily, and placebo gel applied once or twice daily. Each participant undergoes 16 weeks of topical treatment with their assigned gel. During the study, participants will be regularly assessed for treatment effectiveness and safety. Researchers will monitor the response to treatment at Week 16, focusing on the comparison of different ZL-1102 doses against placebo. Patient evaluations include clinical examinations, laboratory tests, and safety monitoring. Participants are asked to avoid prolonged sun exposure and tanning devices during the study period. The total study duration for each participant is 16 weeks.

Researchers are evaluating the effects of macupatide and eloralintide, alone or combined, on weight loss in adults who are overweight or have obesity along with type 2 diabetes. This Phase 2 study aims to understand how these treatments might help reduce body weight in this population. The study is designed as a parallel-group, double-blind, placebo-controlled trial to ensure unbiased results. Participants will receive either macupatide, eloralintide, both drugs together, or matching placebos. All treatments are administered by subcutaneous injection. The study treatment period lasts approximately 48 weeks, during which the effects of the drugs on weight and diabetes control will be assessed. During the study, participants will be monitored for changes in body weight from the start of the study to week 32 as the primary outcome. Researchers will also evaluate safety and other health measures throughout the nearly year-long participation. The study includes regular assessments to track the effects of treatment and to ensure participant health and safety.

Researchers are evaluating how tirzepatide affects body weight and cardiovascular risk factors in adolescents with obesity who also have multiple weight-related health issues. This Phase 3 study aims to assess the safety and effectiveness of tirzepatide combined with healthy nutrition and physical activity. The study includes adolescents aged 12 to 17 years with obesity defined by a high body mass index (BMI) and at least two weight-related comorbidities such as hypertension, prediabetes, or high triglycerides. Participants will receive either tirzepatide or a placebo, both administered by subcutaneous injection once weekly during the primary 72-week study period. Alongside medication, all participants will follow lifestyle interventions focusing on nutrition and physical activity. After completing the initial 72 weeks and a 4-week safety follow-up, eligible participants who have not been off treatment for more than 12 weeks can continue tirzepatide treatment for an additional 156 weeks with ongoing lifestyle support. Throughout the study, up to 23 visits will monitor participants' BMI changes and improvements in weight-related health conditions. Researchers will measure the percentage change in BMI and assess whether participants show significant improvement or normalization in at least two comorbidities without new or worsening conditions over 72 weeks. Safety and efficacy will be closely tracked during the treatment periods and follow-up visits to understand tirzepatide's impact on adolescent obesity and related health risks.

Researchers are evaluating the safety, effectiveness, and tolerability of upadacitinib in adolescents and adults with severe alopecia areata (AA), a condition where the immune system attacks hair follicles causing hair loss on the head, face, or other body parts. This phase 3 study involves about 1500 participants worldwide and compares upadacitinib to a placebo to assess treatment impact on severe AA. Participants are randomly assigned to one of three groups receiving either upadacitinib or placebo oral tablets once daily for up to 160 weeks. There is a chance for re-randomization at weeks 24 and 52 based on Severity of Alopecia Tool (SALT) scores. Those completing initial studies may join an extension study to receive upadacitinib for up to an additional 108 weeks. Follow-up occurs for 30 days after the last dose. Throughout the study, participants attend regular visits at hospitals or clinics for medical assessments, blood tests, side effect monitoring, and questionnaires. Researchers measure the percentage of participants achieving a SALT score of 20 or less at week 24 and track adverse events up to 164 weeks. The study may involve a higher treatment burden compared to usual care due to frequent visits and evaluations.

Researchers are evaluating the safety and effectiveness of FB102 in adults aged 18 to 75 years who have non-segmental vitiligo, a skin condition causing loss of pigmentation. This phase 1, randomized, double-blind, placebo-controlled study will include approximately 64 participants who meet the screening criteria. The goal is to compare FB102 to a placebo in managing vitiligo and to monitor any treatment-related side effects. Participants will be randomly assigned to receive either FB102 or a placebo, both administered intravenously. The study treatments will be given under controlled conditions at multiple centers. The trial is designed to carefully observe participants up to 16 weeks after the first dose to assess treatment impact and safety. During the study, participants will undergo various assessments including monitoring for any adverse events and measuring changes in facial vitiligo area using a standardized scoring system. The number of participants experiencing side effects and the percent change in vitiligo area will be tracked throughout the treatment period and up to 16 weeks from the first dose. This close monitoring helps ensure participant safety and provides detailed information on the treatment's effects.

Researchers are conducting a randomized, double-blind, placebo-controlled study to assess the safety and effectiveness of FB102 in adults with severe to very severe alopecia areata (AA). This condition involves significant hair loss, and the study focuses on patients with at least 50% scalp hair loss, including those with total scalp or complete body hair loss. The trial aims to better understand how FB102 may impact hair loss severity compared to placebo in this patient population. Up to about 32 participants will be randomly assigned in a 3:1 ratio to receive either FB102 or a placebo, both given through intravenous (IV) administration. Participants will receive the assigned treatment according to the study plan, with careful monitoring throughout the trial period. The study is designed to maintain blinding so neither participants nor researchers know who receives FB102 or placebo. Participants will be monitored for safety by tracking any treatment-related or serious adverse events up to 36 weeks after the first dose. The main effectiveness measure is the change from baseline in the Severity of Alopecia Tool (SALT) score at week 16, which assesses the extent of hair loss. The study includes screening, treatment, and follow-up assessments to evaluate these outcomes and ensure participant safety over the course of the trial.

Researchers are conducting a global, multicenter Phase 3b long-term extension study to evaluate barzolvolimab's effects in adults with Chronic Spontaneous Urticaria (CSU) who have completed previous Phase 3 trials. The study aims to determine the time until disease worsening or treatment failure over one year and fulfill a commitment to provide continued access to treatment for eligible participants. The study includes two groups: Group 1 observes participants with a low symptom score (UAS7 less than 16) who do not receive barzolvolimab unless rescue treatment is needed, and Group 2 treats participants with higher symptom scores (UAS7 16 or greater) with barzolvolimab given by subcutaneous injection. Group 1 participants without rescue treatment participate for about 52 weeks, while those requiring rescue and all Group 2 participants may participate for up to 68 weeks. Participants will complete daily symptom diaries and undergo regular assessments to monitor disease activity and treatment effects. The main outcomes include measuring the time until disease worsening, treatment failure, or need for prohibited medications over the study period. Safety and efficacy data will be collected throughout the study duration to understand long-term outcomes with barzolvolimab in CSU.

Researchers are evaluating the safety, pharmacokinetics, and pharmacodynamics of TRB-061, a drug given by subcutaneous injection, in healthy adults and patients with moderate-to-severe atopic dermatitis (AD). This Phase 1a/1b randomized, double-blind, placebo-controlled study includes multiple parts to assess single and multiple doses. The study may adjust the number of dosing groups in the first two parts based on ongoing results. In Part 1, healthy adults receive a single dose of TRB-061 or placebo, followed by 12 weeks of monitoring. In Part 2, healthy adults receive three doses every four weeks over eight weeks, with a 10-week follow-up. Part 3 involves participants with moderate-to-severe AD receiving four doses of TRB-061 or placebo over 12 weeks, followed by a follow-up period. After the main study, those on placebo may have the option to receive the active treatment. Participants will undergo regular safety assessments including medical history, physical exams, laboratory tests, and monitoring for adverse events from screening through follow-up. Researchers will measure the incidence of adverse events and serious adverse events across all parts of the study. The total participation duration varies by part but includes follow-up lasting up to 12 weeks after dosing to ensure safety and collect pharmacological data.

Researchers are evaluating the impact of scaling up finger-stick point-of-care testing for hepatitis C virus (HCV) to improve diagnosis and treatment rates. This observational cohort study focuses on people at risk of HCV infection, including those attending services like drug treatment clinics, needle and syringe programs, prisons, mental health services, and homelessness support. The study aims to address declining treatment uptake and challenges caused by COVID-19, contributing to national efforts to eliminate HCV by 2030. Participants will be offered finger-stick point-of-care testing for HCV antibodies, with results available within 1 to 20 minutes. If the antibody test is positive, a point-of-care HCV RNA test will be done to detect active infection. Those previously infected or treated will directly receive the HCV RNA test. No treatment is provided within the study, but participants with active infection will be connected to standard care services for clinical assessment and treatment initiation. Participants attend a single visit for testing and to complete a self-administered survey. The study will monitor the proportion of participants who start HCV treatment within 12 weeks after testing positive for HCV RNA. Researchers will also link survey data to health records to assess long-term impacts of expanded HCV testing and treatment. This approach aims to improve diagnosis rates and support efforts to reduce HCV-related health burdens.

Researchers are studying whether increasing the use of finger-stick point-of-care testing for hepatitis C virus (HCV) can improve diagnosis and treatment rates among people at risk for HCV infection. This observational cohort study focuses on settings such as drug treatment clinics, needle and syringe programs, homelessness services, mental health services, prisons, and mobile outreach. The study aims to address the decline in HCV treatment uptake in Australia and support national goals to eliminate HCV by 2030 through improved testing and treatment access. Participants will receive finger-stick point-of-care HCV testing at various high-risk service sites. The program includes developing procedures, training operators, and quality assurance to support widespread testing. While participants undergo testing as part of the study, they will not receive treatment through the study itself. Those who test positive for active HCV infection (HCV RNA positive) will be referred to standard care for further clinical assessment and treatment initiation. During the study, data will be collected on all participants receiving point-of-care testing to evaluate how many begin HCV treatment within 12 weeks of enrollment. The research team will monitor testing outcomes, treatment linkage, and adherence to care protocols. This approach aims to understand if scaling up point-of-care testing can increase timely treatment and contribute to reducing the burden of hepatitis C in Australia.