Bois-de-villers, Belgium
Study of DISC-0974 to Assess the Safety, Tolerability, PK and PD of DISC-0974 in Participants with CKD and Anemia
Phase
1Span
165 weeksSponsor
Disc Medicine, IncSaint Clair Shores, Michigan
Recruiting
Prospective Outcomes Study: Vectra® DA Guided Care Compared to Usual Care
To determine whether a strategy of Vectra DA guided care (Arm A), compared with usual care (Arm B), achieves non-inferior clinical outcomes while reducing the cost of treatment in patients with active RA and an inadequate response to MTX monotherapy.
Phase
N/ASpan
326 weeksSponsor
Crescendo BioscienceSt. Clair Shores, Michigan
Recruiting
A Study of Guselkumab Administered Subcutaneously in Bio-naive Participants With Active Psoriatic Arthritis Axial Disease
PsA is a chronic inflammatory musculoskeletal disease that has 6 disease domains, and axial disease represents one of the domains. Guselkumab is a fully human immunoglobulin (Ig) G1 lambda monoclonal antibody (mAb) that by binding to the p19 protein subunit of interleukin (IL)-23, blocks the binding of extracellular IL-23 to the cell surface IL-23 receptor, inhibiting IL-23-mediated intracellular signaling, activation, and cytokine production. This study will consist of a screening phase (up to 6 weeks), a treatment phase (up to 48 weeks, including a placebo-controlled period from Week 0 to Week 24 and an active-controlled treatment phase from Week 24 to Week 48), and a safety follow-up phase (up to Week 60). The efficacy assessments will include assessment such as Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score and the safety assessments will include evaluations of physical examinations, vital signs, electrocardiograms, clinical laboratory tests, and adverse events. The overall duration of the study will be up to 14 months.
Phase
4Span
272 weeksSponsor
Janssen Research & Development, LLCSaint Clair Shores, Michigan
Recruiting
A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Study Participants With Active Psoriatic Arthritis
Phase
3Span
90 weeksSponsor
UCB Biopharma SRLSaint Clair Shores, Michigan
Recruiting
Combined Dose-Finding and CV Outcomes Study With CSL300 (Clazakizumab) in Adult Subjects With ESKD Undergoing Dialysis
Phase
2/3Span
358 weeksSponsor
CSL BehringSaint Clair Shores, Michigan
Recruiting
Saint Clair Shores, Michigan
Recruiting
A Study to Evaluate the Efficacy, Safety, and Tolerability of IMVT-1402 in Adult Participants With Active, Difficult to Treat Rheumatoid Arthritis
The study consists of several periods. During the Screening Period (5 weeks) participants will undergo screening procedures to determine eligibility. In Period 1 (Open-Label Treatment), all eligible participants will receive open-label treatment with IMVT-1402 at a dose of 600 mg subcutaneous (SC) once weekly (QW) for 16 weeks. Participants who meet the ACR20 response criteria at Weeks 14 and 16 will be randomized in a 1:1:1 ratio to receive blinded treatment with either IMVT-1402 600 mg SC QW, IMVT-1402 300 mg SC QW, or placebo SC QW for 12 weeks in Period 2 (Randomized Withdrawal). Eligible participants who complete Period 2 at Week 28 will have the option to receive IMVT-1402 for an additional 48 weeks in Period 3 (Long -Term Extension). A follow-up visit will occur 4 weeks after the last dose of study treatment to monitor safety. The primary endpoint of the study is the proportion of participants achieving an ACR20 response at the end of Period 2. Secondary objectives include evaluating the safety and tolerability of IMVT-1402, as well as its effects on other efficacy measures. This study aims to provide valuable data on the use of IMVT-1402 in treating adults with active, difficult-to-treat, ACPR-positive RA.
Phase
2Span
142 weeksSponsor
Immunovant Sciences GmbHSaint Clair Shores, Michigan
Recruiting
Open-label, Long-term Safety Study of Secukinumab in Polymyalgia Rheumatica (PMR)
The study will consist of an up to 4-week screening period, an up to 2-year Treatment Period which includes two Treatment Periods, and a 16-week treatment-free follow-up period (20 weeks post last dose of secukinumab). Treatment period: There will be two Treatment Periods (TPs): TP1 will be from the first dose administration of secukinumab (Baseline) to Week 24, where visits will occur every 4 weeks, and TP2 will be from post Week 24 visit (post-dose) to up to 2 years. Participants will return to the study site every 4 weeks from Baseline until Week 24 (Weeks 16 and 20 visits are optional on-site visits and needed when participants are unwilling/uncomfortable to self-administer study treatment at home/offsite), then every 12 weeks afterwards in TP2 for resupply of study medication but may return earlier if needed (i.e., those participants who are unwilling/uncomfortable to self-administer study treatment can continue to visit site every 4 weeks for drug administration if they wish to do so). Follow-up period: An EoS visit (20 weeks after last administration of secukinumab) will be done for all participants, regardless of whether they complete the entire study as planned, or they discontinue prematurely.
Phase
3Span
189 weeksSponsor
Novartis PharmaceuticalsSaint Clair Shores, Michigan
Recruiting
Phase 2/3 Adaptive Study of VX-147 in Adult and Pediatric Participants With APOL1- Mediated Proteinuric Kidney Disease
Phase
2/3Span
222 weeksSponsor
Vertex Pharmaceuticals IncorporatedSaint Clair Shores, Michigan
Recruiting
A Study of Zasocitinib in Adults With Psoriatic Arthritis Who Have Not Taken Biologic Medicines
Phase
3Span
152 weeksSponsor
TakedaSaint Clair Shores, Michigan
Recruiting