Prurigo Nodularis Clinical Trial
Official title:
Prospective, Non-interventional Observational Study to Characterize Dupilumab Long-term Treatment, Safety and Patient Reported Outcomes in Chronic Nodular Prurigo (Prurigo Nodularis) in Clinical Routine
Prurigo nodularis (PN) is a skin disease characterized by the presence of single to multiple symmetrically distributed, intensively itching nodules. The main symptom is uncontrollable itching leading to prolonged, repetitive, and uncontrollable rubbing, scratching which in turn causes injuries to the skin. In recent years, number of studies evaluating PN, the affected population and the disease burden has increased but PN remains still understudied. This non-interventional study is intended to describe the long-term effectiveness of dupilumab (Dupixent®) in participants aged 18 years or older and suffering from moderate-to-severe PN who receive dupilumab for PN treatment in a real-world setting in Germany according to the prescribing information (Summary of Product Characteristics [SmPC]). The decision to initiate dupilumab treatment is made by the treating physician and participant according to the participant's medical need and to the standard of best medical practice. This decision is made independently and before data inclusion in this non-interventional study.
The individual observational period is planned to be up to 2 years, with assessments at baseline, one month after baseline and afterwards, every 3 months in the 1st and every 6 months in the 2nd year after dupilumab initiation, respectively. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05038982 -
Efficacy of Abrocitinib for Reducing Pruritus in Adults With Prurigo Nodularis and Chronic Pruritus of Unknown Origin
|
Phase 2 | |
Completed |
NCT00869089 -
Safety and Efficacy of CC-10004 for Prurigo Nodularis
|
Phase 2 | |
Completed |
NCT04501666 -
An Efficacy and Safety Study of Nemolizumab (CD14152) in Participants With Prurigo Nodularis
|
Phase 3 | |
Completed |
NCT03181503 -
Safety and Efficacy of Nemolizumab in PN
|
Phase 2 | |
Completed |
NCT03630198 -
Pain Outcomes Following Intralesional Corticosteroid Injections
|
Phase 4 | |
Completed |
NCT04944862 -
A Study of CDX-0159 in Patients With Prurigo Nodularis
|
Phase 1 | |
Completed |
NCT05061693 -
A Study to Evaluate the Efficacy and Safety of INCB054707 in Participants With Prurigo Nodularis
|
Phase 2 | |
Completed |
NCT03546816 -
Study of the Efficacy, Safety and Tolerability of Serlopitant for the Treatment of Pruritus (Itch) With Prurigo Nodularis
|
Phase 3 | |
Recruiting |
NCT06293053 -
A Study to Investigate the Pharmacokinetics and Safety of Dupilumab in Participants ≥6 Months to <18 Years of Age With Prurigo Nodularis
|
Phase 3 | |
Not yet recruiting |
NCT06201715 -
Efficacy and Safety of Tofacitinib in Patients With Prurigo Nodularis
|
N/A | |
Completed |
NCT02174419 -
Study of Nalbuphine HCl ER Tablets in Patients With Prurigo Nodularis
|
Phase 2/Phase 3 | |
Terminated |
NCT03540160 -
Study of the Long Term Safety of Serlopitant for the Treatment of Pruritus (Itch)
|
Phase 3 | |
Recruiting |
NCT06427122 -
Effect of EMD Protocol for Urge on Dermatology-specific Quality of Life
|
N/A | |
Completed |
NCT03816891 -
Study to Assess the Efficacy, Safety, and Tolerability of Vixarelimab in Reducing Pruritus in Prurigo Nodularis
|
Phase 2 | |
Recruiting |
NCT05764161 -
A Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Prurigo Nodularis (PN)
|
Phase 3 | |
Completed |
NCT02196324 -
A Randomized Placebo-Controlled Study of the Neurokinin-1 (NK1) Receptor Antagonist Serlopitant Prurigo Nodularis (PN)
|
Phase 2 | |
Not yet recruiting |
NCT06424470 -
Study on the Treatment of Prurigo Nodularis With Stapokibart Injection
|
Phase 3 | |
Recruiting |
NCT03576287 -
Apremilast as Anti-pruritic Treatment in Patients With Prurigo Nodularis
|
Phase 1/Phase 2 | |
Completed |
NCT05052983 -
A Study to Evaluate the Durability of Response and Safety of Nemolizumab for 24 Weeks in Participants With Prurigo Nodularis
|
Phase 3 | |
Active, not recruiting |
NCT04204616 -
A Long-term Study of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN)
|
Phase 3 |