Prurigo NodularisPhase 2/3NCT06554509
Clinical Study of the Efficacy and Safety of SHR-1819 Injection in Adult Patients With Prurigo Nodularis
A Phase 2/3 study testing SHR-1819 Injection in people with Prurigo Nodularis, run by Guangdong Hengrui Pharmaceutical Co., Ltd at 1 site in China.
Trial summary
This trial was designed to evaluate the efficacy and safety of SHR-1819 injection in patients with Prurigo Nodularis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prurigo Nodularis
- What is being tested?
- SHR-1819 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 423 participants
- Where
- 1 siteChina
- Study dates
- 19 Sep 2024to Oct 2028
- Phase
- Phase 2/3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects voluntarily sign informed consent forms prior to the commencement of any proceedings related to the study, are able to communicate smoothly with the investigator, understand and are willing to complete the study in strict compliance with the requirements of this clinical research protocol.
- The age was ≥18 at the time of signing the informed consent and gender is unlimited.
- Has prurigo nodularis at screening.
Who cannot join
- Pregnant or lactating women.
- Screening for people with a history of heavy alcohol consumption or substance abuse in the 6 months prior to screening.
- Has an active skin disease or skin complications due to other diseases that may affect the evaluation of PN.
- PN secondary to medical conditions such as neurological or psychiatric disorders.
- Diagnosis of moderate to severe AD during the screening/lead-in period or prior to randomization.
- History of clinically significant diseases (e.g., circulatory system abnormalities, endocrine system abnormalities, neurological disorders, hematologic disorders, immune system disorders, psychiatric disorders, and metabolic instability) that the researcher believes that participation in the study poses a risk to the safety of the subject or that the disease/illness worsens during the study period will affect the effectiveness or safety analysis.
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- Phase II: Treated with biologics targeting IL-4Rα, or participated in previous clinical studies of biologics targeting IL-4Rα, including SHR-1819 injection. Phase III: Subjects who have previously received anti-IL-4Rα biologics for any indication including atopic dermatitis (AD), asthma, sinusitis, etc., and were judged by the investigator to have an inadequate response or intolerance (e.g., experienced drug-related adverse reactions requiring treatment discontinuation) must be excluded even if the washout requirement is met.
- Subjects with malignancy prior to screening (except for squamous cell carcinoma of the skin, basal cell carcinoma, or carcinoma in situ of the cervix that are completely resected and have no evidence of recurrence).
- Major surgeries are planned for the duration of the study.
- Other conditions that, in the opinion of the investigator, are not suitable for participation in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality, 100032
Jianzhong Zhang, +86-18001315877, Rmzjz@126.com
Jianzhong Zhang
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II/III Clinical Study of the Efficacy and Safety of SHR-1819 Injection in Adult Patients With Prurigo Nodularis
This trial was designed to evaluate the efficacy and safety of SHR-1819 injection in patients with Prurigo Nodularis.
- Conditions
- Prurigo Nodularis
- Being tested
- SHR-1819 Injection, SHR-1819 Injection Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-1819 InjectionDrug
SHR-1819 injection.
SHR-1819 Injection PlaceboDrug
SHR-1819 injection placebo.
| Study group | Role | What they receive |
|---|---|---|
| SHR-1819 Injection Group | Experimental | SHR-1819 injection with different doses. Receives: Drug: SHR-1819 Injection |
| SHR-1819 Injection Placebo Group | Placebo comparator | SHR-1819 injection placebo. Receives: Drug: SHR-1819 Injection Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase II: Proportion of subjects with a ≥ 4-point reduction from baseline in the weekly mean of the Most Intense Pruritus Numeric Rating Scale (WI-NRS) at Week 16
Participants were asked daily to rate the intensity of their worst pruritus (itch) over the past 24 hours, using a 11-point scale ranging from 0 (no itch) to 10 (worst imaginable itch). Higher scores indicated more severity.
Measured: Up to 16 weeks.
Phase III: Proportion of subjects with a ≥ 4-point reduction from baseline in the weekly mean of the Most Intense Pruritus Numeric Rating Scale (WI-NRS) at Week 24
Participants were asked daily to rate the intensity of their worst pruritus (itch) over the past 24 hours, using a 11-point scale ranging from 0 (no itch) to 10 (worst imaginable itch). Higher scores indicated more severity.
Measured: Up to 24 weeks.
Secondary outcomes (9)
Phase II: Weekly mean change from baseline and percentage change in weeks 2, 4, 8, 12, and 16 of WI-NRS
Participants were asked daily to rate the intensity of their worst pruritus (itch) over the past 24 hours, using a 11-point scale ranging from 0 (no itch) to 10 (worst imaginable itch). Higher scores indicated more severity.
Measured: Up to 16 weeks.
Phase II: Proportion of subjects with IGA CNPG-S score of 0/1 at weeks 4, 8, 12 and 16
It consists of a 5-point scale ranging from 0 to 4 where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe. Higher scores indicate severe PN.
Measured: Up to 16 weeks.
Phase II: Change from baseline in Dermatology Life Quality Index (DLQI) score at weeks 4, 8, 12, 16
It comprises of set of 10 questions. Responses to each question were assessed on a 4-point Likert scale ranged from 0 (not at all) to 3 (very much). Scores from all 10 questions added up to give total DLQI scores ranged from 0 (not at all) to 30 (very much), higher scores indicated more impact on quality of life.
Measured: Up to 16 weeks.
Phase III: Proportion of subjects with an IGA CNPG-S score of 0/1 at Week 24
It consists of a 5-point scale ranging from 0 to 4 where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe. Higher scores indicate severe PN.
Measured: Up to 24 weeks.
Phase III: Proportion of subjects with IGA CNPG-S score of 0/1 at every study visit
It consists of a 5-point scale ranging from 0 to 4 where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe. Higher scores indicate severe PN.
Measured: Up to 52 weeks.
Phase III: Change from baseline in Dermatology Life Quality Index (DLQI) score at every study visit
It comprises of set of 10 questions. Responses to each question were assessed on a 4-point Likert scale ranged from 0 (not at all) to 3 (very much). Scores from all 10 questions added up to give total DLQI scores ranged from 0 (not at all) to 30 (very much), higher scores indicated more impact on quality of life.
Measured: Up to 52 weeks.
Phase II/III: The concentration of SHR-1819 in serum (AUC)
The concentration of SHR-1819 in plasma will be determined.
Measured: From the beginning of administration to the 24/60th week.
Phase II/III: Changes in the level of IgE in the serum
Changes in the level of biomarkers in serum.
Measured: From the beginning of administration to the 24/60th week.
Phase II/III: Immunogenic endpoint - evaluate the incidence of ADA positivity for SHR-1819
Incidence of immunogenicity in the body.
Measured: From the beginning of administration to the 24/60th week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2024
- Study start19 Sep 2024
- Primary completionOct 2028 (estimated)
- Study completionOct 2028 (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 Guangdong Hengrui Pharmaceutical Co., LtdThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- SHR-1819 compared with placebo
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 423 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Hengrui Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06554509
- Sponsor's protocol ID
- SHR-1819-302
- Status last verified
- Apr 2026
- First submitted
- 5 Aug 2024
- Last updated
- 29 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II/III Clinical Study of the Efficacy and Safety of SHR-1819 Injection in Adult Patients With Prurigo Nodularis
- ClinicalTrials.gov ID
- NCT06554509
- Acronym / sponsor ID
- SHR-1819-302
- Conditions
- Prurigo Nodularis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 423 participants (estimated)
- Lead sponsor
- Guangdong Hengrui Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 19 Sep 2024 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 15 Aug 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 trial was designed to evaluate the efficacy and safety of SHR-1819 injection in patients with Prurigo Nodularis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- SHR-1819 compared with placebo
| Arm | Type | Receives |
|---|---|---|
| SHR-1819 Injection Group | Experimental | Drug: SHR-1819 InjectionSHR-1819 injection with different doses. |
| SHR-1819 Injection Placebo Group | Placebo comparator | Drug: SHR-1819 Injection PlaceboSHR-1819 injection placebo. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects voluntarily sign informed consent forms prior to the commencement of any proceedings related to the study, are able to communicate smoothly with the investigator, understand and are willing to complete the study in strict compliance with the requirements of this clinical research protocol.
- The age was ≥18 at the time of signing the informed consent and gender is unlimited.
- Has prurigo nodularis at screening.
Key exclusion criteria (10 listed)
- Pregnant or lactating women.
- Screening for people with a history of heavy alcohol consumption or substance abuse in the 6 months prior to screening.
- Has an active skin disease or skin complications due to other diseases that may affect the evaluation of PN.
- PN secondary to medical conditions such as neurological or psychiatric disorders.
- Diagnosis of moderate to severe AD during the screening/lead-in period or prior to randomization.
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 |
|---|---|---|
| SHR-1819 InjectionSHR-1819 injection. | Drug | SHR-1819 Injection Group |
| SHR-1819 Injection PlaceboSHR-1819 injection placebo. | Drug | SHR-1819 Injection Placebo Group |
Primary outcome
Phase II: Proportion of subjects with a ≥ 4-point reduction from baseline in the weekly mean of the Most Intense Pruritus Numeric Rating Scale (WI-NRS) at Week 16
Time frame: Up to 16 weeks.
Participants were asked daily to rate the intensity of their worst pruritus (itch) over the past 24 hours, using a 11-point scale ranging from 0 (no itch) to 10 (worst imaginable itch). Higher scores indicated more severity.
Phase III: Proportion of subjects with a ≥ 4-point reduction from baseline in the weekly mean of the Most Intense Pruritus Numeric Rating Scale (WI-NRS) at Week 24
Time frame: Up to 24 weeks.
Participants were asked daily to rate the intensity of their worst pruritus (itch) over the past 24 hours, using a 11-point scale ranging from 0 (no itch) to 10 (worst imaginable itch). Higher scores indicated more severity.
9 secondary outcomes
Phase II: Weekly mean change from baseline and percentage change in weeks 2, 4, 8, 12, and 16 of WI-NRS
Time frame: Up to 16 weeks.
Phase II: Proportion of subjects with IGA CNPG-S score of 0/1 at weeks 4, 8, 12 and 16
Time frame: Up to 16 weeks.
Phase II: Change from baseline in Dermatology Life Quality Index (DLQI) score at weeks 4, 8, 12, 16
Time frame: Up to 16 weeks.
Phase III: Proportion of subjects with an IGA CNPG-S score of 0/1 at Week 24
Time frame: Up to 24 weeks.
Phase III: Proportion of subjects with IGA CNPG-S score of 0/1 at every study visit
Time frame: Up to 52 weeks.
Phase III: Change from baseline in Dermatology Life Quality Index (DLQI) score at every study visit
Time frame: Up to 52 weeks.
Phase II/III: The concentration of SHR-1819 in serum (AUC)
Time frame: From the beginning of administration to the 24/60th week.
Phase II/III: Changes in the level of IgE in the serum
Time frame: From the beginning of administration to the 24/60th week.
Phase II/III: Immunogenic endpoint - evaluate the incidence of ADA positivity for SHR-1819
Time frame: From the beginning of administration to the 24/60th week.
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 29 Apr 2026.
- Individual participant dataSharing planned: Undecided
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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 2/3 study testing SHR-1819 Injection in people with Prurigo Nodularis, run by Guangdong Hengrui Pharmaceutical Co., Ltd at 1 site in China.
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 3 inclusion and 10 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 29 Apr 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 China. 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 combined 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.
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 Huiliu Wang (+86-0518-82342973, huiliu.wang.hw330@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase II: Proportion of subjects with a ≥ 4-point reduction from baseline in the weekly mean of the Most Intense Pruritus Numeric Rating Scale (WI-NRS) at Week 16 (time frame: Up to 16 weeks.). The study lists 2 primary outcomes in all. 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 29 Apr 2026.