Long-term effects of dupilumab on chronic nodular prurigo
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
Sanofi · NCT06087627
This study is testing how well and safely dupilumab works for adults with moderate-to-severe chronic nodular prurigo over two years in a real-world setting.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sanofi (industry) |
| Drugs / interventions | dupilumab |
| Locations | 11 sites (Adernach and 10 other locations) |
| Trial ID | NCT06087627 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the long-term effectiveness and safety of dupilumab in patients aged 18 and older suffering from moderate-to-severe chronic nodular prurigo (PN) in a real-world clinical setting in Germany. Participants will be assessed at baseline, one month after starting treatment, and subsequently every three months in the first year and every six months in the second year. The decision to initiate dupilumab treatment is made by the treating physician based on the patient's medical needs. The study seeks to gather patient-reported outcomes and safety data over a two-year period.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are newly initiating treatment with dupilumab for moderate-to-severe chronic nodular prurigo.
Not a fit: Patients who have been treated with dupilumab for more than 7 days or have contraindications to the medication may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term management and effectiveness of dupilumab for patients with chronic nodular prurigo.
How similar studies have performed: While there have been studies on dupilumab for other conditions, this specific approach to chronic nodular prurigo is relatively novel and underexplored.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participants at least 18 years of age at baseline visit * Signed written informed consent * New initiation with dupilumab or in whom treatment with dupilumab was started within the last 7 days for moderate to severe prurigo nodularis according to the prescribing information/Summary of Product Characteristics (SmPC) * Patients who received the initial diagnosis of PN Exclusion Criteria: * Patients who have a contraindication to dupilumab according to the current prescribing information label/SmPC * Patients who have been treated for more than 7 days with dupilumab * Any acute or chronic condition that, in the treating physician´s opinion, would limit the patient´s ability to complete questionnaires or to participate in this study or impact the interpretation of the results * Participation in an ongoing interventional or observational study that might, in the treating physician´s opinion, influence the assessments for the current study The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
Where this trial is running
Adernach and 10 other locations
- Investigational Site Number: 013 — Adernach, Germany (RECRUITING)
- Investigational site number: 001 — Berlin, Germany (RECRUITING)
- Investigational Site Number: 002 — Berlin, Germany (RECRUITING)
- Investigational Site Number: 023 — Chemnitz, Germany (RECRUITING)
- Investigational Site Number: 005 — Düren, Germany (RECRUITING)
- Investigational Site Number: 004 — Düsseldorf, Germany (RECRUITING)
- Investigational Site Number: 007 — Hamburg, Germany (RECRUITING)
- Investigational Site Number: 016 — Leipzig, Germany (RECRUITING)
- Investigational Site Number: 031 — Mainz, Germany (RECRUITING)
- Investigational Site Number: 022 — Potsdam, Germany (RECRUITING)
- Investigational Site Number: 024 — Potsdam, Germany (RECRUITING)
Study contacts
- Study coordinator: Trial Transparency email recommended (Toll free for US & Canada)
- Email: Contact-US@sanofi.com
- Phone: 800-633-1610
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Prurigo Nodularis