Fredericton

Researchers are evaluating the effectiveness of delgocitinib cream 20 mgg applied twice daily compared to a cream vehicle in treating adults with mild to severe palmoplantar pustulosis PPP. This trial is a phase 2a, double-blind study focusing on this skin condition characterized by pustules on the palms and soles. The main goal is to see how well delgocitinib cream improves symptoms over a 16-week treatment period. Participants will be randomly assigned to one of two groups one group will apply delgocitinib cream twice a day for 16 weeks, while the other group will use a matching vehicle cream twice daily for the same duration. The study includes a total of approximately 18 weeks for each participant, involving around 9 visits. The trial compares the active cream to the placebo cream to assess efficacy and safety. During the study, participants will attend scheduled visits to monitor their condition and collect data on skin symptoms, pustule counts, and quality of life measures. Researchers will assess the improvement in PPP severity using specific scales such as the PPP Area and Severity Index PPPASI. Safety is monitored through reports of any treatment-emergent side effects. Overall participation lasts about 18 weeks, including screening and treatment phases.

Researchers are evaluating the effects of the drug NB-4746 compared with a placebo in adults with amyotrophic lateral sclerosis ALS. This trial aims to understand the safety of NB-4746, how the drug moves through the body, and changes in a blood marker called neurofilament light NfL that reflects nerve cell damage. The study is conducted in two parts and includes an option for participants to join an open-label extension phase. In Part A, participants are randomly assigned to one of three groups low-dose NB-4746 capsules taken twice daily, high-dose NB-4746 capsules taken twice daily, or placebo capsules taken twice daily, all for about one month. In Part B, participants are randomly assigned to either NB-4746 at a dose determined from Part A or placebo, both taken twice daily for approximately 12 weeks. After completing Part A or B, participants may choose to enter an open-label extension to continue treatment for up to one year. During the trial, participants will have their ALS symptoms and overall health monitored regularly. The study team will assess safety by recording treatment-emergent adverse events and serious adverse events. Blood samples will be collected to measure NfL levels and evaluate drug movement in the body. Participants will be followed throughout the study and during the extension phase to track health status and treatment effects up to one year.

Researchers are evaluating the long-term safety and effectiveness of APG777 in adults with moderate-to-severe atopic dermatitis who have completed treatment in a previous APG777 study. This phase 2 extension study involves participants who, according to their doctors, would benefit from continued treatment with APG777. The study is designed as a multicenter, double-blind trial to assess ongoing treatment outcomes and safety over several years. Participants in this study will continue receiving APG777 through three main periods a screening visit coinciding with the last visit of the prior studys maintenance period, an extended treatment period, and a post-treatment follow-up period. Participants who met certain skin improvement criteria and did not use topical rescue medication during the prior study will maintain their previous dose and injection frequency. Those who did not meet these criteria or used rescue medication will receive APG777 according to a specific dosing plan in an open-label escape arm. During the study, participants will be closely monitored for treatment-emergent adverse events up to 3 years. The research team will also measure skin improvements using tools such as the Eczema Area and Severity Index EASI and the Investigator Global Assessment for Atopic Dermatitis vIGA-AD, as well as tracking itch severity, use of rescue therapy, and serum drug concentrations. The overall participation time includes up to 3 years of follow-up to evaluate long-term safety and efficacy outcomes.

Researchers are evaluating various treatment strategies for Gram-negative bloodstream infections GN BSIs in a large, ongoing platform trial called BALANCE. This trial aims to improve treatment methods, patient outcomes, and reduce antimicrobial resistance. It builds on previous research and uses an adaptive design to answer critical questions about managing these serious infections in hospitalized patients. The trial studies different treatment approaches including antibiotic de-escalation, oral beta-lactam versus non-beta-lactam antibiotics, whether to replace or retain central vascular catheters, selecting cephalosporins or carbapenems for specific bacteria, and the use of routine follow-up blood cultures. Participants are randomly assigned to one of these treatment strategies within each domain, with ongoing adjustments based on interim analyses. The initial pilot study has completed, and all patients from that phase are included in the main trial. Participants will be monitored over 90 days for outcomes including death, reinfection, hospital readmission, and development of new antimicrobial resistance. Evaluations include laboratory tests, clinical assessments, and tracking of antibiotic use and patient health status. The trial uses a ranking scale combining these outcomes to determine the desirability of each treatment strategy. This adaptive platform design allows continuous learning and refinement of treatments to improve care for people with GN BSIs.

Researchers are studying the impact and burden of three skin conditions moderate or severe alopecia areata, non-segmental vitiligo, and moderate to severe hidradenitis suppurativa. The study includes adolescents and adults and aims to understand how these conditions affect quality of life and daily functioning in a large global population. This is an observational study where participants with each condition will have a single visit for data collection following routine clinical practice. No experimental treatments are given instead, the study gathers information during this one visit to assess disease characteristics and impact. During the visit, participants will complete questionnaires and clinical assessments specific to their condition. These include tools measuring symptom impact, hair loss severity, skin depigmentation, and quality of life related to each disease. This helps researchers better understand the real-world burden of these conditions. Participation involves only this one visit, with no long-term follow-up or additional procedures.

Hidradenitis Suppurativa HS is a skin condition that causes painful bumps, abscesses, scars, and tunnels in areas where the skin rubs together. This condition may start when hair follicles become damaged, triggering the immune system and allowing bacteria to worsen the symptoms. Researchers are evaluating the safety, effectiveness, and tolerance of a drug called zasocitinib in adults with moderate to severe HS compared with a placebo in this Phase 2 clinical trial. Participants will be randomly assigned to receive either zasocitinib or a placebo for the first 16 weeks in a double-blind period. After this, all participants will receive zasocitinib for an additional 36 weeks in an open-label period. The placebo capsules look like zasocitinib but contain no medicine. Treatment dosing involves a specific dose of zasocitinib labeled as Dose A. During the study, participants will visit the clinic 12 times for assessments. Researchers will monitor the percentage of participants achieving a 75% reduction in HS symptoms at week 16 as the primary outcome. They will also track safety through adverse events and other measures throughout the 56 weeks of treatment. Participants will undergo evaluations including clinical exams, questionnaires, and safety tests to understand treatment effects and tolerability.

Vitiligo is a long-term autoimmune condition that causes the skin to lose its color due to the immune system mistakenly attacking pigment-producing skin cells called melanocytes. This leads to patches of skin with less or no pigment, often appearing symmetrically on both sides of the body in the nonsegmental form of vitiligo. The study aims to evaluate the safety, effectiveness, and tolerability of the drug zasocitinib in adults with nonsegmental vitiligo. Participants will receive oral capsules of zasocitinib at low, medium, or high doses for up to 52 weeks. Some participants will initially receive a placebo for 24 weeks, then switch to medium or high doses of zasocitinib for the remainder of the study. The placebo capsules look identical to zasocitinib but do not contain active medicine. The study uses a randomized, double-blind design with several experimental groups receiving different doses or placebo. During the study, participants will visit the clinic 11 times over one year. Researchers will assess the improvement in vitiligo using facial and total Vitiligo Area Scoring Index F-VASI and T-VASI at baseline and week 24. Safety and tolerability will also be monitored throughout. The primary outcome is the percentage of participants achieving at least 75% improvement in F-VASI at week 24. Secondary outcomes include other measures of vitiligo area improvement. Participants health and response to treatment will be closely followed until the studys end.

This clinical trial investigates the efficacy and safety of bimekizumab compared with placebo in adults with palmoplantar pustulosis PPP, a skin condition causing pustules on the palms and soles. The study is a Phase 3, randomized, double-blind, placebo-controlled trial with an open-label extension, aiming to evaluate treatment responses and safety outcomes in participants diagnosed with PPP for at least 24 weeks and who are candidates for systemic therapy or phototherapy. Participants are randomly assigned to one of two groups one group receives bimekizumab for the entire study duration, while the other receives placebo initially before switching to bimekizumab in the maintenance phase. Treatments are given at specified time points throughout the study, which includes an initial treatment period followed by a maintenance period under open-label conditions. During the study, participants undergo assessments including the Palmoplantar pustulosis-Investigator Global Assessment PPP-IGA response at Week 16, Palmoplantar Pustulosis Area Severity Index PPPASI responses at Weeks 8 and 16, and quality of life evaluations via the Dermatology Life Quality Index DLQI. Researchers monitor pain scores, adverse events, and serious side effects from baseline through safety follow-up up to Week 117. Participants will be closely observed through regular visits and evaluations during these periods.

Researchers are evaluating the safety and tolerability of elranatamab combined with iberdomide in patients with relapsed or refractory multiple myeloma, a cancer of plasma cells. This phase 1b study includes two parts the first part assesses safety and tolerability, while the second part determines the appropriate dose of this combination for patients whose disease has returned or not responded to prior treatments. Participants receive elranatamab as a shot under the skin and take iberdomide by mouth once daily for 21 days in each 28-day treatment cycle. The study includes a non-randomized dose escalation phase and a randomized dose assignment phase. Treatment continues until disease progression, unacceptable side effects, or participant choice to stop. Both parts of the study monitor participants closely for treatment effects. During the study, participants will have regular assessments including monitoring for side effects, laboratory tests, and evaluations of disease response and progression. The main outcomes include the number of participants with dose-limiting toxicities and adverse events related to treatment, measured during the first cycle and up to 90 days after the last dose. Long-term measures such as response rates, survival times, and drug concentrations will be followed for up to two years. This information will help understand treatment safety and appropriate dosing.

Researchers are evaluating the combination of elranatamab, daratumumab, and lenalidomide compared with the combination of daratumumab, bortezomib, lenalidomide, and dexamethasone in adults with newly diagnosed multiple myeloma who are not candidates for transplant. This phase 3 study aims to determine whether the new combination offers better clinical benefits by assessing safety, tolerability, minimal residual disease negative complete response rates, and progression-free survival. The study has two parts. Part 1 focuses on characterizing the safety and tolerability of elranatamab combined with daratumumab and lenalidomide or with lenalidomide alone, and determining the best dose. Part 2 compares the effectiveness of elranatamab plus daratumumab and lenalidomide against the standard combination of daratumumab, bortezomib, lenalidomide, and dexamethasone in participants with newly diagnosed multiple myeloma. Participants receive study drugs according to their assigned group, and dosing and combinations vary by part and arm. Participants will undergo regular assessments including monitoring of disease status, progression, and response using criteria such as minimal residual disease and progression-free survival. Safety will be monitored through adverse event reporting and laboratory tests. Quality of life will also be evaluated using questionnaires. The study may last up to several years, with follow-up extending up to 97 months to assess long-term outcomes and survival.