- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06012812
A Study to Extend Efficacy and Safety of SHR-1819 Injection in Adult Patients With Moderate to Severe Atopic Dermatitis
November 12, 2023 updated by: Shanghai Hengrui Pharmaceutical Co., Ltd.
A Multicenter, Open-label, Extended Study Evaluating the Safety and Efficacy of SHR-1819 Injection in Adult Subjects With Moderate to Severe Atopic Dermatitis Who Have Previously Participated in SHR-1819 Studies for the Treatment of Atopic Dermatitis
This study is a multicenter, open-label, extended study to evaluate the safety, efficacy, pharmacokinetics, and immunogenicity of SHR-1819 injection in adult subjects with moderate to severe atopic dermatitis who have previously participated in the SHR-1819 injection study for atopic dermatitis (defined as the main study, referred to as the main study hereinafter).
Study Overview
Status
Enrolling by invitation
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
240
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Guangchao Dong
- Phone Number: 0518-82342973
- Email: guangchao.dong@hengrui.com
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200040
- Huashan Hospital,Fudan University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- The age of 18~75 years old at the time of signing the informed consent form (including the values at both ends), gender is not limited;
- Previous atopic dermatitis, (1) participation in a complete main study; or (2) subjects who prematurely terminate primary study therapy for reasons other than SHR-1819 injection are required to complete a last safety follow-up or withdrawal from the visit, and the investigator assesses that the influencing factor has been eliminated/no longer affects the participant's participation in the extended study. Participants were required to meet the main study inclusion criteria for the main study;
- Be able to apply a topical emollient (moisturizer) continuously for at least 7 consecutive days before the first dose and continue to use it for the duration of the study;
- Be able to sign informed consent forms, understand and agree to follow the requirements of the study and the trial process.
Exclusion Criteria:
- Pregnant or lactating women;
- Female subjects of childbearing potential and male subjects whose partners are women of childbearing age have a plan to donate sperm/eggs from the signing of the informed consent form until 3 months after the last dose of the trial drug, or refuse to comply with the relevant contraceptive requirements;
- A history of alcohol abuse or illicit drug abuse within 6 months prior to screening;
- Hypersensitivity to the study drug or any ingredient in the study drug;
- Diagnosed within 6 months prior to screening or judged by the investigator to have a suspected immunosuppressive disease;
- Oral or parenteral systemic antimicrobials are used within 2 weeks before the first dose;
- Suspected or confirmed active tuberculosis (TB);
- Have malignancy or history of malignancy prior to screening;
- Major surgery was performed within 3 months prior to screening, or major surgery was planned during the study;
- There are currently significant abnormal laboratory test results, severe concomitant diseases, and other circumstances that the investigator considers inappropriate to participate in this trial;
- There were treatment-related adverse events leading to discontinuation of treatment and study drug-related SAEs in the main study, and the investigator or sponsor medical department considered that continuing to participate in extended therapy would pose an unacceptable safety risk to participants.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SHR-1819 injection
|
SHR-1819 injection 300 mg Q2W
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Treatment Emergent Adverse Events (TEAEs) (per person-year)
Time Frame: Up to 60 weeks
|
Up to 60 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Serious Adverse Event (SAE) during treatment (per person-year)
Time Frame: Up to 60 weeks
|
Up to 60 weeks
|
Adverse Events of Special Interest (AESI) during treatment (per person-year)
Time Frame: Up to 60 weeks
|
Up to 60 weeks
|
Proportion of participants with a Global Assessment (IGA) score of 0 or 1 (0-4 scale) per visit
Time Frame: Up to 60 weeks
|
Up to 60 weeks
|
Time to first remission (remission defined as IGA = 1 or 0 after treatment) in this study (for participants visiting 2 baseline IGAs ≥2)
Time Frame: Up to 60 weeks
|
Up to 60 weeks
|
Proportion of participants with at least 1 remission in this study
Time Frame: Up to 60 weeks
|
Up to 60 weeks
|
Time to first relapse in this study (relapse defined as IGA = 3 or 4 points after remission) (for participants with Visit 2 baseline IGA ≥ 2)
Time Frame: Up to 60 weeks
|
Up to 60 weeks
|
The concentration of SHR-1819 in serum :Cmax
Time Frame: From the beginning of administration to the 60h week
|
From the beginning of administration to the 60h week
|
Immunogenic endpoint: evaluate the incidence and timing of ADA positivity for SHR-1819
Time Frame: From the beginning of administration to the 60th week
|
From the beginning of administration to the 60th week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 6, 2023
Primary Completion (Estimated)
May 30, 2025
Study Completion (Estimated)
May 30, 2025
Study Registration Dates
First Submitted
August 22, 2023
First Submitted That Met QC Criteria
August 22, 2023
First Posted (Actual)
August 28, 2023
Study Record Updates
Last Update Posted (Actual)
November 14, 2023
Last Update Submitted That Met QC Criteria
November 12, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SHR-1819-203
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Moderate to Severe Atopic Dermatitis
-
Regeneron PharmaceuticalsSanofiCompletedModerate to Severe Atopic Hand and Foot DermatitisUnited States, Germany, Japan, Poland
-
SanofiRegeneron PharmaceuticalsRecruitingModerate to Severe Atopic DermatitisCanada
-
Beijing InnoCare Pharma Tech Co., Ltd.RecruitingModerate to Severe Atopic DermatitisChina
-
Keymed Biosciences Co.LtdRecruitingModerate-to-severe Atopic DermatitisChina
-
Galderma R&DRecruitingModerate-to-Severe Atopic DermatitisUnited States, Denmark, Hungary, Poland, Spain
-
Shanghai Hengrui Pharmaceutical Co., Ltd.CompletedModerate to Severe Atopic DermatitisChina
-
Galderma R&DActive, not recruitingModerate-to-Severe Atopic DermatitisUnited States, Australia, Austria, Belgium, Bulgaria, Canada, Czechia, Estonia, France, Georgia, Germany, Hungary, Italy, Korea, Republic of, Latvia, Lithuania, Netherlands, New Zealand, Poland, Singapore, Spain, United Kingdom
-
Galderma R&DCompletedModerate-to-Severe Atopic DermatitisUnited States, Belgium, Bulgaria, Estonia, France, Georgia, Germany, Hungary, Italy, Poland, Singapore
-
Galderma R&DCompletedModerate-to-Severe Atopic DermatitisUnited States, Australia, Austria, Canada, Czechia, Germany, Korea, Republic of, Latvia, Lithuania, Netherlands, New Zealand, Poland, Spain, United Kingdom
-
Keymed Biosciences Co.LtdCompletedModerate-to-severe Atopic DermatitisChina
Clinical Trials on SHR-1819 injection
-
Shanghai Hengrui Pharmaceutical Co., Ltd.Not yet recruiting
-
Shanghai Hengrui Pharmaceutical Co., Ltd.Completed
-
Suzhou Suncadia Biopharmaceuticals Co., Ltd.Enrolling by invitationAdvanced Malignant TumorsChina
-
Shengjing HospitalJiangsu HengRui Medicine Co., Ltd.Not yet recruitingER Positive/HER2 Low Breast CancerChina
-
Guangdong Hengrui Pharmaceutical Co., LtdRecruitingChronic Rhinosinusitis With Nasal PolypsChina
-
Guangdong Hengrui Pharmaceutical Co., LtdCompleted
-
Suzhou Suncadia Biopharmaceuticals Co., Ltd.Not yet recruiting
-
Henan Cancer HospitalRecruitingHER2 Low Breast CarcinomaChina
-
Jiangsu HengRui Medicine Co., Ltd.Not yet recruitingNasopharyngeal CarcinomaChina