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A Non-interventional Study to Describe the Dupilumab Long-term Treatment, Safety and Patient Reported Outcomes in Chronic Nodular Prurigo (Prurigo Nodularis) in Clinical Routine — CLEAR PN  

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

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06087627
Study type Observational [Patient Registry]
Source Sanofi
Contact Trial Transparency email recommended (Toll free for US & Canada)
Phone 800-633-1610
Email Contact-US@sanofi.com
Status Recruiting
Phase
Start date December 27, 2023
Completion date December 28, 2026
View Details
See also
  Status Clinical Trial Phase
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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
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Active, not recruiting 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
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
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
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
Not yet 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
Recruiting NCT06213831 - A Study to Evaluate the Safety and Tolerability of Maximal Use Ruxolitinib Cream Phase 1
Not yet recruiting NCT04681300 - Transcriptomic Landscape of T Lymphocytes of Atopic Dermatitis, Atopic Prurigo Nodularis (of Besnier) and Non-atopic Prurigo Nodularis (of Hyde) Using Single Cell RNA-sequencing