Auburn Hills

Researchers are evaluating litifilimab (BIIB059), a monoclonal antibody, in adults with active cutaneous lupus erythematosus (CLE). This includes those with subacute or chronic CLE, with or without systemic lupus erythematosus (SLE), who have not responded well or tolerated antimalarial treatments. The study aims to assess how litifilimab affects skin disease activity using scoring tools such as CLA-IGA-R and CLASI, as well as its safety and impact on quality of life. The study has two parts: Part A and Part B. After screening, participants are randomly assigned to receive either litifilimab or a placebo injection under the skin every four weeks for 24 weeks in a double-blind setup. After this, all participants receive litifilimab for another 28 weeks. Those who finish may join a long-term extension study or enter a safety follow-up lasting up to 24 weeks. Treatment involves regular injections and monitoring during these periods. Participants will undergo assessments of skin symptoms, immune responses, and quality of life using questionnaires. Researchers will measure outcomes like the percentage of participants achieving low skin redness scores and significant reductions in skin disease activity. Safety monitoring continues through the study and follow-up, with total participation lasting up to 80 weeks.

Researchers are evaluating BFB759, a biological drug that inhibits multiple pro-inflammatory cytokines, in adults with moderate to severe atopic dermatitis. This phase 2, double-blind, placebo-controlled study aims to compare how well BFB759 works and its safety against a placebo over about 36 to 40 weeks. The study is sponsored by Bluefin Biomedicine, Inc. and includes participants aged 18 to 75 years with atopic dermatitis lasting at least one year. Participants are randomly assigned to one of three groups: a high dose of BFB759, a low dose of BFB759, or placebo given every two weeks. The treatment period lasts through Week 14, followed by a placebo period for the active groups from Weeks 16 to 30. Those initially receiving placebo are re-randomized at Week 16 to receive BFB759 through Week 30. This design allows comparison of different doses and assessment of treatment effects over time. During the study, participants attend regular visits for up to 40 weeks to monitor how well the treatment works, assessed at Weeks 16 and 32, as well as to track safety and tolerability over about 21 months with around 22 visits. Researchers will collect data on disease improvement and any side effects. Participants are expected to follow study instructions, attend all visits, and avoid certain medications during the trial to help ensure accurate results.

Researchers are evaluating the safety and effectiveness of BFB759, a human monoclonal antibody that targets multiple inflammatory cytokines, in adults with moderate to severe hidradenitis suppurativa (HS) that is not well controlled by systemic antibiotics. This double-blind, placebo-controlled study involves participants aged 18 to 75 years and aims to understand how well BFB759 works compared to a placebo over approximately 36 to 40 weeks. Participants will be randomly assigned to one of several groups. Some will receive a loading dose of BFB759 followed by either a high or mid maintenance dose every two weeks through Week 14. Others will receive a placebo every two weeks for 14 weeks, then, if still enrolled, be re-randomized to receive either a low or mid dose of BFB759 every two weeks from Week 16 through Week 30. This design allows comparison of different dosing regimens and the placebo effect. During the study, participants will attend about 22 visits over 21 months to monitor safety and effectiveness. Researchers will measure clinical activity using scales such as HiSCR50, the International Hidradenitis Suppurativa Severity Score System (IHS4), Skin Pain Numerical Rating Scale, and the Hidradenitis Suppurativa-Investigator Global Assessment (HS-IGA). Participants are expected to follow study instructions carefully, attend regular visits, and avoid certain medications. The primary outcomes focus on efficacy at Weeks 16 and 32, with ongoing safety assessments throughout the study.

Researchers are evaluating the safety and effectiveness of ruxolitinib cream in children and adolescents aged 6 to under 18 years with moderate atopic dermatitis. This condition involves skin inflammation and itching, and the study aims to provide new treatment options by comparing ruxolitinib cream to a matching vehicle cream. The trial is a Phase 3b, randomized, double-blind study sponsored by Incyte Corporation. Participants will be assigned randomly to receive either ruxolitinib cream or a vehicle cream. The creams will be applied twice daily or twice weekly depending on the study period. The study includes a vehicle-controlled phase and a disease control phase, with an open-label extension period where all participants may receive ruxolitinib cream. The treatment regimen also allows twice-daily application during disease flare-ups. During the study, participants will regularly visit the clinic for assessments including skin evaluations using the Eczema Area and Severity Index (EASI), Investigator's Global Assessment, itch severity ratings, and quality of life questionnaires. Blood samples will be taken to measure drug levels and safety labs. The study will monitor adverse events and disease flare-ups for up to 70 weeks. Participants and their guardians will keep diaries to track symptoms and cream usage throughout the trial.

Researchers are evaluating the safety and effectiveness of tapinarof cream, 1%, in young children aged 3 months to less than 24 months who have atopic dermatitis, a skin condition. This global Phase 3 clinical study aims to better understand how well the cream works and how safe it is for this very young age group. Participants will be randomly assigned to apply either tapinarof cream or a vehicle cream (a placebo) once daily to affected skin areas for up to 8 weeks during a double-blind period. After this phase, all participants may use tapinarof cream once daily as needed during an open-label period lasting up to 56 weeks. The study compares the effects of tapinarof cream against the vehicle cream and monitors participants over time. Throughout the study, caregivers and researchers will assess skin improvement using the Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) and the Eczema Area and Severity Index (EASI). Safety will be closely monitored by recording any treatment-related side effects and local skin reactions. The trial includes regular visits and evaluations over the initial 8-week double-blind phase and continued monitoring during the longer open-label phase, which can last up to 56 weeks in total.

Alopecia areata (AA) is a chronic autoimmune condition causing nonscarring hair loss on the scalp and other body areas, affecting people of all ages, genders, and races. The main types include patchy alopecia, alopecia totalis, and alopecia universalis. Researchers aim to study the real-world effectiveness and patient outcomes of ritlecitinib, a drug approved for treating severe AA in patients 12 years and older, building on results from previous clinical trials. Participants in this observational study will receive ritlecitinib as prescribed by their doctors according to the approved label and standard care practices, independent of the study. The study will follow patients over time to observe treatment patterns, disease progression, and responses to ritlecitinib in routine clinical settings. Treatment dosing and schedules will be determined by physicians based on individual patient needs. Throughout the study, participants will attend regular clinic visits to assess disease severity, hair regrowth, and other clinical features using tools like the Severity of Alopecia Tool score. Patient-reported outcomes such as treatment satisfaction and quality of life will also be collected. Researchers will monitor changes over weeks 24, 48, 72, and 96 to evaluate effectiveness and safety. The study aims to capture comprehensive real-world data on ritlecitinib use in AA patients.

Researchers are evaluating the long-term safety of Deucravacitinib compared to Ustekinumab in adults with moderate-to-severe plaque psoriasis who have certain cardiovascular risk factors. This Phase 3b/4 randomized, open-label study aims to assess cardiovascular and other safety outcomes over several years to better understand risks associated with these treatments in this patient group. The study is sponsored by Bristol-Myers Squibb. Participants will be randomly assigned to receive either Deucravacitinib or Ustekinumab at specified doses on designated days. The study is designed to compare these two treatments over a long-term period, including up to five years of follow-up for major cardiovascular events and other health outcomes related to psoriasis treatment. During the study, participants will undergo regular monitoring for cardiovascular events such as heart attacks, strokes, and revascularization procedures, as well as other serious health events including infections and malignancies. Researchers will also track changes in liver function and lipid levels. The total duration of participant involvement can last up to five years, with safety assessments extending up to 60 days after the last dose of study medication.

This research aims to evaluate how well the mymobility app measures knee range of motion compared to a clinician's traditional goniometer assessment. The study focuses on knee range of motion and will observe the agreement between these two measurement methods. It is an observational study sponsored by Zimmer Biomet. Participants will have their knee range of motion measured three times during a single visit. First, the mymobility app will be used to assess the knee's range of motion. Then, two different assessors will each measure the knee range of motion twice using a goniometer, with each assessor unaware of the other's measurements. This process allows comparison between the app and standard clinical tools. During the visit, researchers will record active knee flexion, active knee extension, and passive knee extension with overpressure. These measurements will help determine the agreement between the app and clinical assessments. The study involves only one visit, and participants will undergo these evaluations during that time to contribute to the research findings.

Researchers are evaluating the pharmacokinetics, safety, and effectiveness of povorcitinib in adolescents aged 12 to 17 years with moderate to severe hidradenitis suppurativa. This phase 2, open-label study aims to understand how the drug behaves in the body and its impact on this skin condition over a 54-week period. Participants have moderate to severe disease and have not responded adequately to previous systemic treatments. Participants will be assigned to receive one of two doses of povorcitinib orally as tablets for 54 weeks. The study monitors how the drug is absorbed, distributed, and cleared from the body during the first 24 weeks, while safety and skin condition responses are assessed throughout the full treatment period. The study does not use randomization or blinding. During the study, participants will undergo regular evaluations including monitoring of treatment-emergent adverse events and measurement of drug levels in the blood. Researchers will also assess changes in skin lesions, abscesses, draining tunnels, and skin pain using standardized clinical response criteria and quality of life questionnaires. This comprehensive monitoring helps understand the drug's safety and impact over the 54-week treatment period.

Researchers are studying the real-world effectiveness of nemolizumab in adults with moderate-to-severe Prurigo nodularis (PN), a chronic skin condition. This observational study aims to assess outcomes reported by both investigators and patients over six months, focusing on how the treatment works in routine clinical practice. The study follows adults newly prescribed nemolizumab by their physicians. Participants will be observed for about 12 months while receiving treatment as part of their regular medical care. No extra visits, procedures, or lab tests beyond usual clinical practice are required. A sub-study in Germany and the UK will have some participants record their itch intensity and sleep disturbance daily for the first two weeks through remote data collection. Participants will have routine clinical visits determined by their doctors, with data collected during these visits. Researchers will assess outcomes such as the Investigator Global Assessment of chronic prurigo and patient-reported peak itch intensity at six months and up to 12 months. Sleep disturbance and prurigo activity will also be tracked. This approach allows long-term monitoring of treatment effects in a real-world setting without added study-related procedures.