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Can a biologic drug quiet the relentless itch of prurigo nodularis?

NCT ID NCT06087627

Disease control Sponsor: Sanofi Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 31, 2026 · Last updated Jul 31, 2026

Summary

This study follows adults with moderate-to-severe prurigo nodularis—a skin condition marked by intensely itchy nodules—who are starting treatment with dupilumab (Dupixent) as part of their normal care. Researchers will track how well the drug reduces itching and clears skin lesions over six months, along with its safety and impact on quality of life. Because it is an observational study, participants receive the drug as prescribed by their doctor, and no experimental treatment is provided.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
dupilumab (Dupixent), a biologic drug given by injection
What this could lead to
If successful, this study could provide real-world evidence on how well dupilumab controls itching and skin lesions in prurigo nodularis over time, potentially supporting its broader use.
What could go wrong
As an observational study, it cannot prove cause and effect, and results may be influenced by patient selection or missing data. Long-term safety and effectiveness in routine practice may differ from clinical trials.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

110 people

The number who actually took part.

Started

Dec 2023

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Participants ≥ 18 years suffering from moderate-to-severe PN who receive long-term dupilumab treatment for PN in a real-world setting in Germany.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

prurigo nodularis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Prurigo nodularis

Contacts and locations

Locations

  • Investigational Site Number: 002

    Berlin, 13507, Germany

  • Investigational Site Number: 004

    Düsseldorf, 40219, Germany

  • Investigational Site Number: 005

    Düren, 52349, Germany

  • Investigational Site Number: 007

    Hamburg, 22391, Germany

  • Investigational Site Number: 013

    Adernach, 56626, Germany

  • Investigational Site Number: 016

    Leipzig, 04371, Germany

  • Investigational Site Number: 022

    Potsdam, 14467, Germany

  • Investigational Site Number: 023

    Chemnitz, 09117, Germany

  • Investigational Site Number: 024

    Potsdam, 14469, Germany

  • Investigational Site Number: 031

    Mainz, 55128, Germany

  • Investigational site number: 001

    Berlin, 12203, Germany

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