PruritisPhase 2NCT06226610
Dupixent in Adults With Refractory Post-Burn Pruritus in an Ambulatory Clinic
A Phase 2 study testing Dupilumab in people with Pruritis, run by Akron Children's Hospital at 1 site in United States.
Trial summary
The goal of this study is to test the efficacy of Dupixent in improving post-burn itching symptoms versus the current standard of care. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Pruritis
- What is being tested?
- Dupilumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Nov 2024to 31 Dec 2027
- Phase
- Phase 2
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Persons 18-60 year old with post-burn hypertrophic scars of any size which required grafting or epidermal autografting for an acute burn injury, with continued complaint of pruritus due to inadequate relief from standard of care (medical management by antihistamine and neuroleptic medications) after at least four weeks and are a minimum of four weeks after their last grafting surgery, and who speak English sufficient to participate in the study.
Who cannot join
- Currently taking Dupixent for any other diagnosis
- known allergy to Dupixent
- pregnant and or lactating mothers
- anyone treated for pruritus using laser therapy
- currently receiving adequate relief for pruritis under standard of care medical management by antihistamine or neuroleptic medications
- Currently taking steroids
Show all 12Show fewer
- persons with developmental delays or otherwise unable to complete measures
- prisoners or anyone otherwise unable to give their own consent or who is not their own guardian
- one or more of the following existing disorders: conjunctivitis; any co-existing dermatological condition except burns; any type of cancer; requiring dialysis; chronic Stage 3 or higher kidney disease; biliary disorder; gall bladder disorder; or another renal or hepatic disorder which, in the opinion of study physician, deems this study inappropriate for an eligible individual.
- Persons unable to provide their own consent, including prisoners when their incarcerated status is not itself the focus of study, are routinely excluded from clinical trials at this site
- We further exclude persons with other dermatological conditions (other than burn) , which may have pruritis or pain associated with them and who may be treated with medications other than Dupixent, and whose perceived benefit could confound our results.
- We similarly exclude anyone treated for pruritis by laser therapy as their perceived benefit could confound our results.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Akron Children's Hospital
Akron, Ohio, 44308
Anjay Khandelwal, MD, 330-543-4649, akhandelwal@akronchildrens.org
Jessica Kracker, BSN, 330-543-0846, jkracker@akronchildrens.org
About this study
Official title: A Phase 2 Double-Blind, Randomized, Placebo-Controlled Study to Assess the Efficacy of Dupixent in Adults With Refractory Post-Burn Pruritus in an Ambulatory Clinic
The goal of this study is to test the efficacy of Dupixent in improving post-burn itching symptoms versus the current standard of care.
Read the detailed description
Participants will receive six injections of Dupixent or placebo (two 300 mg loading doses and one 300 mg dose every two weeks after that).
In addition, participants will be asked to complete questionnaires to determine daily itch severity, quality of life, treatment benefit, physical functioning, and pain interference.
Individual participants will require 13 weeks to complete all study visits.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DupilumabDrug
injection every two weeks while on study
PlaceboOther
injection every two weeks while on study
| Study group | Role | What they receive |
|---|---|---|
| ARM 1 - Dupixent | Active comparator | Two subcutaneous injection of 300mg Dupixent at visit 1 and every two weeks (+/- 2 days) for a total of 6 administrations. Injections may be administered in the thigh, lower abdomen or upper arm. The initial dose (two 300 mg doses) will be given in two different injection sites. There are not restriction or guidance regarding dose administration related to meals. No dose modifications will occur during study participation. Receives: Drug: Dupilumab |
| ARM 2 - Placebo | Placebo comparator | Two subcutaneous injection of the placebo at visit 1 and every two weeks (+/- 2 days) for a total of 6 administrations. Injections may be administered in the thigh, lower abdomen or upper arm. The initial dose (two doses) will be given in two different injection sites. There are not restriction or guidance regarding dose administration related to meals. No dose modifications will occur during study participation. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Itch Severity Scale (ISS) Scores
Participants' Itch Severity Scale (ISS) scores will decrease more than 2.0 points after 12 weeks following initiating use of Dupixent
Measured: 12 WEEKS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2024
- Study start21 Nov 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PruritisStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a dual-arm, two-site, randomized, placebo-controlled interventional Phase 2 randomized controlled clinical trial to estimate the potential effect size of Dupixent on improving post-burn pruritus symptoms. N=46 participants will be enrolled at a 1:1 intervention:control ratio.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Akron Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Regeneron Pharmaceuticals, Ohio State University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06226610
- Sponsor's protocol ID
- 2024-002
- Status last verified
- Oct 2026
- First submitted
- 18 Jan 2024
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Double-Blind, Randomized, Placebo-Controlled Study to Assess the Efficacy of Dupixent in Adults With Refractory Post-Burn Pruritus in an Ambulatory Clinic
- ClinicalTrials.gov ID
- NCT06226610
- Acronym / sponsor ID
- 2024-002
- Conditions
- Pruritis
- Keywords
- Itching, itch
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Akron Children's HospitalUniversity, hospital or other
- Collaborators
- Regeneron Pharmaceuticals, Ohio State University
- Study start
- 21 Nov 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 26 Jan 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.
The goal of this study is to test the efficacy of Dupixent in improving post-burn itching symptoms versus the current standard of care.
Detailed description
Participants will receive six injections of Dupixent or placebo (two 300 mg loading doses and one 300 mg dose every two weeks after that).
In addition, participants will be asked to complete questionnaires to determine daily itch severity, quality of life, treatment benefit, physical functioning, and pain interference.
Individual participants will require 13 weeks to complete all study visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- This is a dual-arm, two-site, randomized, placebo-controlled interventional Phase 2 randomized controlled clinical trial to estimate the potential effect size of Dupixent on improving post-burn pruritus symptoms. N=46 participants will be enrolled at a 1:1 intervention:control ratio.
| Arm | Type | Receives |
|---|---|---|
| ARM 1 - Dupixent | Active comparator | Drug: DupilumabTwo subcutaneous injection of 300mg Dupixent at visit 1 and every two weeks (+/- 2 days) for a total of 6 administrations. Injections may be administered in the thigh, lower abdomen or upper arm. The initial dose (two 300 mg doses) will be given in two different injection sites. There are not restriction or guidance regarding dose administration related to meals. No dose modifications will occur during study participation. |
| ARM 2 - Placebo | Placebo comparator | Other: PlaceboTwo subcutaneous injection of the placebo at visit 1 and every two weeks (+/- 2 days) for a total of 6 administrations. Injections may be administered in the thigh, lower abdomen or upper arm. The initial dose (two doses) will be given in two different injection sites. There are not restriction or guidance regarding dose administration related to meals. No dose modifications will occur during study participation. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Persons 18-60 year old with post-burn hypertrophic scars of any size which required grafting or epidermal autografting for an acute burn injury, with continued complaint of pruritus due to inadequate relief from standard of care (medical management by antihistamine and neuroleptic medications) after at least four weeks and are a minimum of four weeks after their last grafting surgery, and who speak English sufficient to participate in the study.
Key exclusion criteria (12 listed)
- Currently taking Dupixent for any other diagnosis
- known allergy to Dupixent
- pregnant and or lactating mothers
- anyone treated for pruritus using laser therapy
- currently receiving adequate relief for pruritis under standard of care medical management by antihistamine or neuroleptic medications
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 |
|---|---|---|
| Dupilumabinjection every two weeks while on study | Drug | ARM 1 - Dupixent |
| Placeboinjection every two weeks while on study | Other | ARM 2 - Placebo |
Primary outcome
Itch Severity Scale (ISS) Scores
Time frame: 12 WEEKS
Participants' Itch Severity Scale (ISS) scores will decrease more than 2.0 points after 12 weeks following initiating use of Dupixent
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 28 Oct 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dupilumab in people with Pruritis, run by Akron Children's Hospital at 1 site 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 1 inclusion and 12 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 28 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 1 site 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 ANJAY KHANDELWAL, MD (330-543-4649, akhandelwal@akronchildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Itch Severity Scale (ISS) Scores (time frame: 12 WEEKS). 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 28 Oct 2026.