Prurigo NodularisPhase 3NCT06293053
A Study to Investigate the Pharmacokinetics and Safety of Dupilumab in Participants ≥6 Months to <18 Years of Age With Prurigo Nodularis
A Phase 3 study testing Dupilumab in people with Prurigo Nodularis, run by Sanofi at 15 sites in United States.
Trial summary
This is a Phase 3, multicenter, open-label, pharmacokinetics (PK)/safety study. The study consists of 3 periods: Screening period: 2 to 4 weeks. Treatment period: 24 weeks. Post-intervention follow-up period: 16 weeks. Read more about this study
- Who is it for?
- Ages 6 months to 17 years
- Conditions the study is for
- Prurigo Nodularis
- What is being tested?
- Dupilumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 15 sitesUnited States
- Study dates
- 15 May 2024to 3 Nov 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Participants must be ≥6 months to <18 years of age, at the time of signing the informed consent.
- A clinical diagnosis of prurigo nodularis (PN) at least 3 months prior to screening, an Investigator's global assessment for prurigo nodularis stage (IGA PN-S) score of ≥2 with presence of ≥6 pruriginous lesions at Baseline. The lesions should be present on ≥2 different body surface areas at Baseline.
- On the worst itch numerical rating scale (WI-NRS) (for participants aged ≥6 years to <18 years old at the screening visit) or worst-scratch/itch NRS (for participants aged ≥6 months to <6 years at the screening visit) ranging from 0 to 10, participants must have an average worst itch score of ≥7 in the 7 days prior to Day 1.
- NOTE: Baseline pruritus NRS average score for maximum itch intensity will be determined based on the average of daily NRS scores for maximum intensity (the daily score ranges from 0 to 10) during the 7 days immediately preceding the Day 1/Baseline visit. A minimum of 4 daily scores out of the 7 days is required to calculate the baseline average score.
- Participants/Caregivers must be willing and able to complete a daily symptom e-Diary for the duration of the study.
- Contraceptive use by male and female participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Who cannot join
- Participants are excluded from the study if any of the following criteria apply:
- Presence of active moderate to severe lesions of atopic dermatitis (AD), and/or other skin conditions that may interfere with the PN diagnosis including but not limited to the following: scabies, psoriasis, lymphomatoid papulosis, habitual picking, dermatitis herpetiformis, sporotrichosis, and bullous disease.
- Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, or antifungals within 2 weeks before the screening visit or during the screening period.
- NOTE: Participants may be rescreened after infection resolves.
- Known or suspected immunodeficiency, including history of invasive opportunistic infections (eg, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, and aspergillosis) despite infection resolution, or otherwise recurrent infections of abnormal frequency or prolonged duration suggesting an immune compromised status, as judged by the Investigator.
- Severe concomitant illness(es) that, in the Investigator's judgment, would adversely affect the participant's participation in the study.
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- Planned or anticipated major surgical procedure during the participant's participation in this clinical trial.
- Participants who has taken biologic therapy/systemic immunosuppressant/ immunomodulator within 4 weeks before the screening visit or 5 half-lives, whichever is longer.
- Current participation to any clinical trial of an investigational drug or device or participation within 3 months before the screening visit or 5 half-lives of the investigational compound, whichever is longer.
- Participation in prior dupilumab clinical study or have been treated with commercially available dupilumab.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
15 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Trial Transparency email recommended (Toll free for US & Canada) contact
15 sites in 1 country
United States15 sites, 15 recruiting
- Recruiting
Dell Children's Medical Center- Site Number : 8400007
Austin, Texas, 78723
- Recruiting
Pediatric Center of Excellence (PCE) - Miami Pediatric Endocrinology- Site Number : 8400005
Coral Gables, Florida, 33146
- Recruiting
Life Clinical Trials - Coral Springs- Site Number : 8400018
Coral Springs, Florida, 33071
- Recruiting
Driscoll Children's Hospital- Site Number : 8400017
Corpus Christi, Texas, 78411
- Recruiting
Tareen Dermatology - Eagan- Site Number : 8400022
Eagan, Minnesota, 55123
- Recruiting
AXIS Clinicals - Fargo- Site Number : 8400013
Fargo, North Dakota, 58103
- Recruiting
Direct Helpers Research Center- Site Number : 8400015
Hialeah, Florida, 33012
- Recruiting
SunCoast Skin Solutions - Lutz- Site Number : 8400008
Lutz, Florida, 33558
- Recruiting
Stanford University Medical Center (CTRU)- Site Number : 8400021
Palo Alto, California, 94304
- Recruiting
Mission Dermatology Center- Site Number : 8400011
Rancho Santa Margarita, California, 92688
- Recruiting
MediSearch Clinical Trials- Site Number : 8400004
Saint Joseph, Missouri, 64506
- Recruiting
Oakwell Clinical Research- Site Number : 8400020
San Antonio, Texas, 78218
- Recruiting
USF Health- Site Number : 8400003
Tampa, Florida, 33606
- Recruiting
Vital Prospects Clinical Research Institute - Tulsa- Site Number : 8400002
Tulsa, Oklahoma, 74136
- Recruiting
Golden State Dermatology - Walnut Creek - Ygnacio Valley Road- Site Number : 8400023
Walnut Creek, California, 94598
About this study
Official title: A Multicenter Open-label Study to Investigate the Pharmacokinetics and Safety of Dupilumab in Participants ≥6 Months to <18 Years of Age With Prurigo Nodularis
This is a Phase 3, multicenter, open-label, pharmacokinetics (PK)/safety study.
The study consists of 3 periods:
- Screening period: 2 to 4 weeks.
- Treatment period: 24 weeks.
- Post-intervention follow-up period: 16 weeks. The study duration will be approximately 42 to 44 weeks for each participant (including screening, treatment, and follow-up periods).
The total number of planned study visits for each participant will be 6.
- Conditions
- Prurigo Nodularis
- Being tested
- Dupilumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DupilumabDrug
Also called SAR231893, Dupixent
Pharmaceutical form: Injection solution
Route of administration: Subcutaneous
| Study group | Role | What they receive |
|---|---|---|
| Dupilumab | Experimental | Administered subcutaneously (SC) based on weight and age Receives: Drug: Dupilumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of dupilumab in serum
Concentration of dupilumab in serum over time
Measured: Day 1 to Week 40
Secondary outcomes (2)
Incidence of treatment-emergent adverse events (TEAEs) or serious adverse events (SAEs)
Measured: Date of signed ICF (2-4 weeks before Day 1) to Week 40
Incidence of anti-drug antibodies (ADA) to dupilumab over time
Measured: Day 1 to Week 40
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2024
- Study start15 May 2024
- Primary completion28 Oct 2027 (estimated)
- Study completion3 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prurigo NodularisStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06293053
- Sponsor's protocol ID
- PKM17836
- Other IDs
- U1111-1287-7255
- Status last verified
- Oct 2026
- First submitted
- 27 Feb 2024
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Open-label Study to Investigate the Pharmacokinetics and Safety of Dupilumab in Participants ≥6 Months to <18 Years of Age With Prurigo Nodularis
- ClinicalTrials.gov ID
- NCT06293053
- Acronym / sponsor ID
- PKM17836
- Conditions
- Prurigo Nodularis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- 15 May 2024 (actual)
- Primary completion
- 28 Oct 2027 (estimated)
- Study completion
- 3 Nov 2027 (estimated)
- First posted
- 5 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 3, multicenter, open-label, pharmacokinetics (PK)/safety study.
The study consists of 3 periods:
- Screening period: 2 to 4 weeks.
- Treatment period: 24 weeks.
- Post-intervention follow-up period: 16 weeks. The study duration will be approximately 42 to 44 weeks for each participant (including screening, treatment, and follow-up periods).
The total number of planned study visits for each participant will be 6.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dupilumab | Experimental | Drug: DupilumabAdministered subcutaneously (SC) based on weight and age |
Who may qualify
- Ages
- 6 months to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Participants must be ≥6 months to <18 years of age, at the time of signing the informed consent.
- A clinical diagnosis of prurigo nodularis (PN) at least 3 months prior to screening, an Investigator's global assessment for prurigo nodularis stage (IGA PN-S) score of ≥2 with presence of ≥6 pruriginous lesions at Baseline. The lesions should be present on ≥2 different body surface areas at Baseline.
- On the worst itch numerical rating scale (WI-NRS) (for participants aged ≥6 years to <18 years old at the screening visit) or worst-scratch/itch NRS (for participants aged ≥6 months to <6 years at the screening visit) ranging from 0 to 10, participants must have an average worst itch score of ≥7 in the 7 days prior to Day 1.
- NOTE: Baseline pruritus NRS average score for maximum itch intensity will be determined based on the average of daily NRS scores for maximum intensity (the daily score ranges from 0 to 10) during the 7 days immediately preceding the Day 1/Baseline visit. A minimum of 4 daily scores out of the 7 days is required to calculate the baseline average score.
- Participants/Caregivers must be willing and able to complete a daily symptom e-Diary for the duration of the study.
Key exclusion criteria (11 listed)
- Presence of active moderate to severe lesions of atopic dermatitis (AD), and/or other skin conditions that may interfere with the PN diagnosis including but not limited to the following: scabies, psoriasis, lymphomatoid papulosis, habitual picking, dermatitis herpetiformis, sporotrichosis, and bullous disease.
- Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, or antifungals within 2 weeks before the screening visit or during the screening period.
- NOTE: Participants may be rescreened after infection resolves.
- Known or suspected immunodeficiency, including history of invasive opportunistic infections (eg, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, and aspergillosis) despite infection resolution, or otherwise recurrent infections of abnormal frequency or prolonged duration suggesting an immune compromised status, as judged by the Investigator.
- Severe concomitant illness(es) that, in the Investigator's judgment, would adversely affect the participant's participation in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DupilumabAlso: SAR231893, DupixentPharmaceutical form: Injection solution Route of administration: Subcutaneous | Drug | Dupilumab |
Primary outcome
Concentration of dupilumab in serum
Time frame: Day 1 to Week 40
Concentration of dupilumab in serum over time
2 secondary outcomes
Incidence of treatment-emergent adverse events (TEAEs) or serious adverse events (SAEs)
Time frame: Date of signed ICF (2-4 weeks before Day 1) to Week 40
Incidence of anti-drug antibodies (ADA) to dupilumab over time
Time frame: Day 1 to Week 40
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- PKM17836 Plain Language Results SummaryLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Trial Transparency email recommended (Toll free for US & Canada) contact
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dupilumab in people with Prurigo Nodularis, run by Sanofi at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Trial Transparency email recommended (Toll free for US & Canada) (800-633-1610 ext. option 6, contact-us@sanofi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of dupilumab in serum (time frame: Day 1 to Week 40). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.