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Researchers are evaluating the efficacy and safety of trontinemab in people with early symptomatic Alzheimers disease, ranging from mild cognitive impairment to mild dementia due to Alzheimers. This Phase III trial aims to understand how trontinemab affects cognitive decline and disease progression in this population. Participants are randomly assigned to receive either intravenous trontinemab or a placebo in a parallel-group design. Treatment is administered by IV infusion, and the effects are compared over a period of 72 weeks. The study includes comprehensive safety and efficacy assessments throughout this period. During the 72 weeks of the study, participants will undergo various evaluations including cognitive tests such as the Clinical Dementia Rating-Sum of Boxes CDR-SB, Alzheimers Disease Assessment Scales, brain imaging with PET and MRI scans, and biomarker measurements in cerebrospinal fluid and blood. Safety monitoring includes tracking adverse events, infusion reactions, and antibody development. The study requires participants to have a study partner and to complete all study procedures over this time.

Researchers are evaluating the effectiveness and safety of combining inavolisib with a cyclin-dependent kinase 4 and 6 inhibitor CDK46i and letrozole compared to placebo plus CDK46i and letrozole in adults with endocrine-sensitive PIK3CA-mutated hormone receptor-positive HR, HER2-negative advanced breast cancer. This phase III, randomized, double-blind study focuses on participants who have measurable disease and meet specific hormone receptor and HER2 status criteria. Participants are randomly assigned to receive either oral inavolisib once daily along with letrozole and CDK46i or placebo once daily with letrozole and CDK46i. The CDK46i is given on a schedule of either Days 1-21 or Days 1-28 of each 28-day cycle. The study includes parallel groups to compare these treatment combinations over time. During the study, participants will be monitored for progression-free survival, overall survival, response rates, duration of response, clinical benefit, and changes in pain, physical function, and global health status. Safety will be assessed by tracking adverse events and patient-reported treatment side effects using questionnaires. The study will follow participants for up to seven years, with regular evaluations to track disease status and quality of life.

Researchers are evaluating the safety, effectiveness, and behavior in the body of various treatment combinations used alone or together in adults with multiple myeloma, a type of blood cancer. This flexible platform study allows new treatment groups to open as new therapies become available. Two substudies focus on different treatment combinations one with cevostamab and lenalidomide as maintenance after transplant in high-risk patients, and another with cevostamab and iberdomide in patients with relapsed or refractory disease who have had multiple prior treatments. In the first substudy, participants receive cevostamab intravenously with step-up doses followed by regular doses on a 28-day cycle combined with oral lenalidomide on days 1 to 21 of each cycle. The second substudy administers cevostamab intravenously every 3 weeks with oral iberdomide on days 1 to 14 of a 21-day cycle. Additional drugs like dexamethasone and tocilizumab may be used as needed. Each substudy has a dose escalation phase followed by a dose expansion phase, with specific dosing schedules maintained throughout. Participants will be regularly assessed through various tests and procedures to monitor side effects, treatment response, and disease progression over a period of up to about five years. Researchers will measure outcomes like adverse events, response rates, survival times, and drug levels in the body. Participants agree to follow scheduled assessments, and safety monitoring includes managing potential complications such as cytokine release syndrome. The study aims to gather long-term data on these treatment combinations impact on multiple myeloma.

Researchers are evaluating Afimkibart RO7790121 for people with moderately to severely active Crohns disease. This Phase III clinical trial aims to assess the effectiveness and safety of both induction and maintenance therapy using this drug compared to a placebo. The study is designed as a double-blind, placebo-controlled trial across multiple centers. Participants will be randomly assigned to one of three groups receiving either Afimkibart via intravenous infusion followed by subcutaneous injection or matching placebo treatments. The study involves continuous treatment through induction and maintenance phases to compare outcomes at weeks 12 and 52. The trial includes a placebo group to provide a comparison for evaluating Afimkibarts effects. During the study, participants will have regular visits for assessments including clinical remission rates, endoscopic response, symptomatic remission, stool frequency, abdominal pain, and quality of life questionnaires. Researchers will monitor various outcomes over 52 weeks and track adverse events for up to 70 weeks after baseline. This long-term follow-up helps evaluate both the treatments impact and safety throughout the trial period.

Researchers are evaluating the safety and effectiveness of induction therapy using Afimkibart also called RO7790121 in people with moderately to severely active ulcerative colitis UC. This Phase III study is designed as a multicenter, double-blind, placebo-controlled trial to compare Afimkibart with a placebo. The study aims to understand how well Afimkibart works to induce remission in UC and its safety profile. Participants will be randomly assigned to one of two groups. One group will receive Afimkibart through an intravenous IV infusion followed by a subcutaneous SC injection, while the other group will receive matching placebo infusions and injections. The treatment period lasts 12 weeks, during which researchers will assess the effects of the therapies. Throughout the study, participants will undergo various assessments including evaluations of clinical remission, endoscopic improvement, histologic changes, and symptom severity at specified time points such as baseline, Week 2, and Week 12. Safety will be monitored by tracking adverse events for up to 30 weeks after starting treatment. The total participation duration spans the treatment and follow-up periods to gather comprehensive data on outcomes and safety.

Researchers are evaluating the efficacy and safety of Afimkibart also known as RO7790121 as an induction therapy in people aged 16 to 80 with moderately to severely active Crohns disease. This Phase III, multicenter, double-blind, placebo-controlled study aims to compare Afimkibart with placebo to understand its potential benefits and risks for this condition. Participants will be randomly assigned to receive either Afimkibart through an intravenous infusion followed by a subcutaneous injection, or a placebo infusion followed by Afimkibart subcutaneous injection. The study treatment is given to assess the impact on Crohns disease activity over a 12-week period. During the study, participants will have their symptoms and disease activity monitored using assessments like the Crohns Disease Activity Index CDAI, endoscopic evaluations, stool and abdominal pain tracking, and quality of life questionnaires. Safety will be closely observed up to 30 weeks after starting treatment. This study helps to measure remission rates and responses to treatment over time.

Researchers are evaluating the effectiveness and safety of inavolisib combined with Phesgo compared to a placebo combined with Phesgo as maintenance treatment for participants with previously untreated HER2-positive advanced breast cancer that has a PIK3CA mutation. This Phase 3 study focuses on participants with locally advanced or metastatic breast cancer who have completed induction therapy. Participants first receive induction therapy with Phesgo plus taxane-based chemotherapy. Following this, they enter the maintenance phase where they are randomly assigned to receive either inavolisib tablets taken orally once daily for 21 days of each 21-day cycle along with Phesgo administered subcutaneously every 3 weeks, or a matching placebo tablet with Phesgo on the same schedule. Optional endocrine therapy may be given based on the investigators choice according to standard care. Throughout the study, participants undergo regular monitoring including tumor assessments, quality of life questionnaires, and safety evaluations lasting up to approximately 111 months. Key outcomes measured include progression-free survival assessed by investigators, overall survival, response rates, duration of response, and adverse event rates. Plasma concentrations of inavolisib are also measured at specific timepoints. Participants will be followed closely during and after treatment to assess these outcomes over an extended period.

Researchers are studying obefazimod to evaluate its effectiveness and safety as a treatment for adults with moderately to severely active Crohns disease who have not responded well or cannot tolerate conventional or advanced therapies. This Phase 2b trial compares obefazimod with a placebo to see if it can help control symptoms and improve disease activity. The study also aims to assess the long-term safety and tolerability of obefazimod during an extension period. The study includes three treatment phases a 12-week induction phase, a 40-week maintenance phase, and a 48-week extension phase. Participants receive one of four daily treatments obefazimod at doses of 50mg, 25mg, or 12.5mg, or a placebo. All treatments are taken once daily, ideally in the morning with food. The extension phase focuses on monitoring safety and tolerability compared to placebo. Participants will attend regular study visits for assessments including the Crohns Disease Activity Index and endoscopic scores to measure disease activity and response. Safety is monitored through adverse event reports and laboratory tests, including blood work for hematology, coagulation, and biochemistry at various weeks up to the end of the study. The total study duration spans several phases, allowing close observation of treatment effects and safety over time.

Researchers are evaluating the effectiveness and safety of the drug RO7771950 combined with trastuzumab and capecitabine compared to tucatinib combined with trastuzumab and capecitabine in people with locally advanced or metastatic HER2-positive breast cancer. This study includes patients with or without central nervous system metastases and focuses on those who have previously received anti-HER2 therapies. The trial is a randomized, open-label study sponsored by Hoffmann-La Roche, designed to assess treatment outcomes in this patient population. Participants will be assigned to one of three groups two experimental arms receiving different doses of RO7771950 orally twice daily, or a comparator arm receiving tucatinib orally twice daily. All participants will also receive trastuzumab, administered either intravenously or subcutaneously according to local guidelines, and capecitabine taken orally twice daily. The study evaluates these treatments over an extended period to monitor their effects on disease progression and safety. During the trial, participants will undergo regular assessments including imaging scans to measure disease progression, evaluations of heart function, and monitoring of symptoms and quality of life. Researchers will track progression-free survival as the primary outcome, along with secondary measures such as overall survival, response rates, treatment-related side effects, and patient-reported outcomes. The total study duration may extend up to several years to capture long-term results and safety data.

This research aims to identify individuals who may be eligible for interventional studies related to Alzheimers Disease by assessing specific biomarkers and cognitive performance. It is a Phase 3 screening study sponsored by Hoffmann-La Roche designed to evaluate potential participants using blood tests and cognitive assessments. The study focuses on adults aged 50 to 90 years to find candidates for further Alzheimers disease research. Participants will not receive any treatment but will undergo blood draws to measure the concentration of the biomarker pTau217. They will also complete the International Shopping List Test ISLT to assess cognitive function. This screening process helps determine eligibility for linked interventional Alzheimers disease studies by combining biomarker and cognitive data. During the study, participants will provide blood samples and perform cognitive tests at the initial visit. Researchers will measure the pTau217 levels in blood and record cognitive scores from the ISLT. The study involves no experimental treatment, focusing solely on assessment. Participation lasts until the primary completion date, with data collected on Day 1 to evaluate potential eligibility for further trials.