Almada

Researchers are evaluating an investigational drug called OHB-607 to prevent Bronchopulmonary Dysplasia BPD, a common chronic lung disease in extremely premature infants. The study compares infants receiving OHB-607 to those receiving standard neonatal care to see if the drug can reduce the incidence of severe BPD or death by 36 weeks postmenstrual age. This is a Phase 2b, randomized, open-label study involving infants born between 23 weeks 0 days and 27 weeks 6 days gestational age. Participants in the trial will be randomly assigned to one of two groups. One group will receive a continuous intravenous infusion of OHB-607 from birth until 29 weeks and 6 days postmenstrual age. The other group will receive standard neonatal care without the investigational drug. This approach allows researchers to compare the effects of OHB-607 against routine care practices for preventing lung disease in these infants. During the study, infants will be closely monitored through 36 weeks postmenstrual age and up to 24 months corrected age. Researchers will assess lung health, including the incidence and severity of BPD, time to weaning off respiratory support, and other complications such as intraventricular hemorrhage and retinopathy of prematurity. Developmental outcomes will also be measured using standardized scales at 24 months corrected age. Safety assessments and long-term follow-up are included to understand the drugs effects over time.

Researchers are investigating new treatments for Pulmonary Arterial Hypertension PAH, a condition where the blood vessels in the lungs thicken and narrow, causing high blood pressure in the lungs and making it difficult for the heart to work properly. PAH can lead to breathing difficulties and reduced activity levels. While current treatments help manage symptoms, they do not stop the disease from progressing. Sotatercept is a study medicine designed to target specific proteins involved in PAH, and this long-term follow-up study aims to assess its safety and tolerability when used alongside standard PAH treatments over an extended period. Participants who have completed previous sotatercept PAH studies may join this open-label follow-up study. Those from blinded studies will start sotatercept at 0.3 mgkg by subcutaneous injection every three weeks and may increase to 0.7 mgkg. Participants from unblinded studies will continue their current dose and may also increase to 0.7 mgkg. The study focuses on monitoring sotatercept use combined with background PAH therapy to observe long-term effects. Throughout the study, participants will undergo regular assessments including tracking adverse events, laboratory tests for blood and chemistry markers, body weight, blood pressure, and electrocardiograms up to approximately 7 years. Additional measurements include walking distance tests, heart function markers, and risk scores related to PAH. Safety monitoring and tolerance to the medication will be closely observed over time to better understand sotatercepts long-term impact in managing PAH.

Researchers are evaluating how the study medicine CagriSema helps people living with obesity, with or without type 2 diabetes T2D, lose weight. The purpose of this clinical study is to find out how safe and effective CagriSema is for body weight loss compared to semaglutide, a medicine already prescribed by doctors. This is a Phase 3 randomized trial lasting about 83 weeks. Participants will be randomly assigned to receive either one of two doses of CagriSema or semaglutide, all given once weekly by injection under the skin during a 72-week treatment period. CagriSema is a new medicine being tested, while semaglutide serves as an active comparator. The study compares these treatments for their effects on weight loss and related health measures. During the study, participants will have regular assessments including body weight, body mass index BMI, waist circumference, cholesterol levels, and blood sugar control measured by HbA1c. Researchers will also monitor physical function and quality of life through questionnaires. Safety is tracked by recording any adverse events up to 80 weeks. The main outcome is the change in body weight from the start of treatment to the end of the 72-week period.

Researchers are evaluating the short-term and long-term effects and safety of belimumab in adults with early systemic lupus erythematosus SLE who have positive autoantibodies and ongoing disease activity despite stable first-line treatment. This is a prospective, open-label, single-arm Phase 4 clinical study sponsored by GlaxoSmithKline. The study focuses on adults diagnosed within two years with active SLE, aiming to better understand how belimumab works in this group. Participants will receive belimumab GSK1550188 administered subcutaneously throughout the study. The treatment and observation period lasts for three years, with key evaluations at one year and longer-term follow-ups up to three years. There is no placebo or comparison group, as all participants receive the study drug. During the study, participants will have regular visits to assess disease activity, including the Lupus Low Disease Activity State LLDAS at week 52 and other measures such as the SLE Responder Index 4 SRI4, flare frequency, and improvements in skin symptoms. Researchers will monitor safety by tracking adverse events and serious adverse events. Blood tests, questionnaires, and physical assessments will be done to evaluate fatigue, damage, and disease remission. Participants will be followed for up to 156 weeks to assess long-term outcomes and safety.

Researchers are evaluating Risvutatug rezetecan Ris-Rez, a new medicine targeting specific proteins B7-H3 on cancer cells to reduce the growth and spread of relapsed small cell lung cancer SCLC. This Phase 3 study compares Ris-Rez to the standard treatment, topotecan, to see how well Ris-Rez shrinks or eliminates tumors and whether it helps participants live longer. The study also monitors safety and side effects of both treatments to understand their tolerability. Participants will be randomly assigned to receive either Ris-Rez or topotecan. Ris-Rez is a biological treatment given to target the cancer cells, while topotecan is a drug used as the active comparator. The study involves multiple assessments over time, including treatment response and disease progression, lasting up to approximately 139 weeks for some measures. During the study, participants will undergo regular evaluations including imaging scans to assess tumor response, laboratory tests to monitor organ function and side effects, ECGs to check heart function, and assessments of physical activity levels using ECOG performance status. Researchers will also measure overall survival, progression-free survival, adverse events, and participant experiences with the treatments. The total participation duration lasts up to about 113 weeks for overall survival and up to 139 weeks for other secondary outcomes.

This research aims to evaluate the effectiveness and safety of lebrikizumab in people with chronic rhinosinusitis and nasal polyps who are also treated with intranasal corticosteroids. The study is a Phase 3 clinical trial lasting about 18 months and includes participants aged 12 years and older. It is designed to understand how lebrikizumab works alongside standard nasal spray treatment for this condition. Participants will receive lebrikizumab through subcutaneous injections every 2, 4, or 8 weeks, depending on the assigned group. All participants continue using their regular intranasal corticosteroid sprays during the study. Adolescents aged 12 to under 18 years will receive open-label lebrikizumab injections every 2 or 4 weeks. There is also a placebo group receiving injections without the active drug but with the same nasal spray background treatment. During the study, participants will be monitored regularly for changes in nasal congestion and nasal polyp size over 24 weeks, using participant reports and endoscopic examinations. Other assessments include sinus imaging, lung function tests, smell loss severity, postnasal drip symptoms, and quality of life questionnaires. Safety and adherence will be closely observed throughout the 18-month study period to ensure participant well-being.

Researchers are evaluating nipocalimab compared to placebo in adults with moderate to severe Systemic Lupus Erythematosus SLE, a chronic condition where the immune system attacks healthy tissues causing inflammation in various organs. This Phase 3 study aims to measure how well nipocalimab works using the SLE Responder Index SRI-4 response at Week 52 as the primary outcome. Participants will be randomly assigned to receive either nipocalimab or placebo along with standard care treatments during a 52-week double-blind period. After Week 52, eligible participants from both groups can join an open-label extension where they will receive nipocalimab until Week 156 or until the treatment is stopped. Throughout the study, participants will have regular assessments including physical exams, medical history reviews, vital signs, ECGs, and disease activity scoring. Researchers will track responses such as disease activity, joint pain, fatigue, and flare status at Week 52. Safety monitoring will continue during the extension period, with total participation lasting up to about three years.

Migraine is a condition that often causes moderate to severe headaches on one side of the head, sometimes accompanied by symptoms like throbbing, nausea, vomiting, and sensitivity to light and sound. This research aims to evaluate the safety and effectiveness of atogepant compared to a placebo in preventing chronic migraine in participants aged 12 to 17 years. Atogepant is already approved for adults and is now being studied for younger patients to understand its impact on this age group. Participants will be randomly assigned to receive either atogepant or a placebo, both given as oral tablets once daily for 12 weeks. The study is designed to be double-blind, so neither the participants nor the doctors will know who receives the active medicine or the placebo. After the 12-week treatment period, participants will be followed for an additional 4 weeks for further observation. During the study, participants will attend regular visits at a hospital or clinic where they will complete daily diaries, undergo medical assessments, blood tests, and questionnaires to monitor side effects and treatment effects. Researchers will measure the number of participants experiencing adverse events and changes in monthly migraine days, among other outcomes. The total participation time, including treatment and follow-up, will be approximately 16 weeks.

Researchers are evaluating trastuzumab deruxtecan T-DXd as a treatment for adult patients with advanced HER2-positive gastric or gastroesophageal junction GEJ adenocarcinoma who have previously received a trastuzumab-based regimen. This study aims to assess the real-world effectiveness of T-DXd, patient characteristics, treatment patterns, and safety in this population. It also includes data collection on patients receiving conventional therapies for exploratory comparison. This is a non-interventional observational study where patients receive T-DXd or conventional therapies as part of routine clinical care according to approved guidelines SmPC. No investigational drugs are given. The study tracks patients starting T-DXd as a second-line or later treatment and collects data on other therapies such as chemotherapy and immunotherapy used in clinical practice. Participants will be followed for up to approximately 2 years from baseline to monitor outcomes including time to next treatment, changes in treatment, physician-reported safety events, use of prophylactic treatments, and quality of life using validated questionnaires. Data on physician visits, treatment discontinuation, and safety events will also be collected to understand treatment tolerability and patient experience in a real-world setting.

Researchers are evaluating whether adding tucatinib to trastuzumab and mFOLFOX6 works better than the current standard treatments for people with HER2 positive metastatic colorectal cancer. This study focuses on participants whose cancer has spread or cannot be removed by surgery. The trial also monitors side effects that might occur from taking these drug combinations. Participants are randomly assigned to one of two groups. One group receives tucatinib taken orally twice daily along with trastuzumab given intravenously every three weeks and mFOLFOX6 chemotherapy every two weeks. The other group receives standard care, which includes mFOLFOX6 alone or combined with bevacizumab or cetuximab given by intravenous infusion. The study treatments continue as per the assigned schedule. During the study, participants undergo regular scans and evaluations to measure progression-free survival and other outcomes up to approximately three years. Researchers also assess overall survival, response rates, duration of response, quality of life, and side effects for up to about six years. Safety monitoring continues for around one year after the last treatment. Participants are closely followed to understand the impact of these treatments on their cancer and well-being.