Atopic DermatitisPhase 3NCT06477835
A Study to Evaluate the Efficacy and Safety of SIM0718 in Adult and Adolescent Patients With Moderate to Severe Atopic Dermatitis
A Phase 3 study testing SIM0718 Injection in people with Atopic Dermatitis, run by Simcere Pharmaceutical Co., Ltd at 1 site in China.
Trial summary
This study will evaluate the efficacy and safety of SIM0718 in adolescents (12- < 18 years) and adults (18-75 years) with moderate to severe AD. Read more about this study
- Who is it for?
- Ages 12 to 75 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- SIM0718 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 259 participants
- Where
- 1 siteChina
- Study dates
- 4 Jul 2024to 23 Dec 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 12 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age ≥ 12 and ≤ 75 years, male or female, and body weight ≥ 40 kg at the screening visit.
- Diagnosis of atopic dermatitis at screening (according to the American Academy of Dermatology Concordance Criteria, 2014), and: 1) Adult diagnosed AD for ≥ 12 months and adolescent diagnosed AD for ≥ 6 months prior to screening; 2) Inadequate response or intolerance to topical medications, or is medically inappropriate for topical treatment judged by the investigator within 6 months prior to Screening; 3) At Screening and Baseline,IGA score ≥3; 4)At Screening and Baseline, EASI score ≥ 16; 5) At Screening and Baseline,total AD involvement ≥ 10% BSA; 6) Baseline peak pruritus NRS score ≥ 4.
Who cannot join
- Not enough washing-out period for previous therapy.
- History of any of the following:
- 1) History of significant immune reactions (eg, serum sickness, anaphylaxis, or delayed hypersensitivity) to any other biologic agent or any excipient of SIM0718; 2) Presence of other active skin comorbidities other than AD that may interfere with study assessments, such as scabies, skin lymphoma, or psoriasis; 3) Active keratoconjunctivitis and atopic keratoconjunctivitis at screening; or previous history of recurrent keratoconjunctivitis and atopic keratoconjunctivitis; 4) Patients with active tuberculosis (TB), latent TB, or a history of nontuberculous mycobacterial infection at screening; 5) HBsAg positive at screening; or HBcAb positive with HBV-DNA positive; or hepatitis C antibody positive with HCV RNA polymerase chain reaction positive; or HIV serology positive; 6) Systemic treatment with antibiotics, antivirals, antiparasitic agents, antiprotozoal agents, or antifungal agents for infections within 4 weeks prior to baseline, or superficial skin infections within 1 week prior to baseline that could interfere with study assessments (subjects could be re-screened after resolution of infection); 7) History of parasitic infection within 6 months prior to baseline; 8) According to the investigator 's judgment, known or suspected history of immunosuppression within 6 months prior to baseline, including but not limited to history of invasive opportunistic infections, such as aspergillosis, coccidioidomycosis, histoplasmosis, HIV, listeriosis, pneumocystis disease or tuberculosis; or the presence of abnormal frequent recurrent or persistent infections; 9) History of malignancy within 5 years prior to screening.
- 3. Planned major surgical procedures during the study.
- 4. History of alcohol or drug abuse within 2 years before screening.
- 5. Any other condition that, in the judgment of the investigator, would make participation in this study inappropriate.
Show all 9Show fewer
- 6. Female subjects of childbearing potential, who experience any of the following
- Positive serum pregnancy test or positive urine pregnancy test before baseline
- Pregnant or breastfeeding women, or women planning to become pregnant or breastfeeding during the study who are unwilling to use at least one highly effective form of birth control throughout the study and for 90 days after the last dose of study drug.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of SIM0718 in Adult and Adolescent Patients With Moderate to Severe Atopic Dermatitis
This study will evaluate the efficacy and safety of SIM0718 in adolescents (12- < 18 years) and adults (18-75 years) with moderate to severe AD.
Read the detailed description
This is a randomized, double-blind, placebo-controlled multicenter clinical study to evaluate the efficacy and safety of SIM0718 in adolescents (12- < 18 years) and adults (18-75 years) with moderate to severe AD. Subjects who meet entry criteria will be randomized to receive either SIM0718 or matching placebo.The study includes a screening period, a treatment period and a follow-up period.
- Conditions
- Atopic Dermatitis
- Being tested
- SIM0718 Injection
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SIM0718 InjectionBiological
Subjects who meet entry criteria will be randomized in a 1:1 ratio to receive either SIM0718 or matching placebo,Q2W, SC until Week 16. At the Week 16 visit, subjects in the placebo group will be transferred to SIM0718 300 mg Q2W after completing safety and efficacy assessments. Subjects who were originally treated with 300 mg Q2W of SIM0718 will continue on their original treatment regimen.
| Study group | Role | What they receive |
|---|---|---|
| Test group | Active comparator | During the placebo-controlled double-blind treatment phase, subjects were randomized 1:1 to the following treatment groups:
• Test group: SIM0718 300 mg SC with loading dose of 600 mg on Day 1.
During the W16-W52 Maintenance Period:
• All subjects were dosed SC at 300 mg SIM0718. Receives: Biological: SIM0718 Injection |
| Control group | Placebo comparator | During the placebo-controlled double-blind treatment phase, subjects were randomized 1:1 to the following treatment groups:
• Volume-matched placebo SC, placebo loading dose on Day 1.
During the W16-W52 Maintenance Period:
• All subjects were dosed SC at 300 mg SIM0718. Receives: Biological: SIM0718 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
EASI-75 at week 16
Proportion of subjects achieving EASI-75 at week 16.
Measured: Day1-Week16
IGA score at week 16
Proportion of subjects with IGA score of 0 or 1 and a reduction of IGA score by ≥2 points from baseline at week 16.
Measured: Day1-Week16
Secondary outcomes (7)
EASI-75 at each visit
Proportion of subjects achieving EASI-75 at each visit
Measured: Day1-Week52
EASI-50 at each visit
Proportion of subjects achieving EASI-50 at each visit
Measured: Day1-Week52
EASI-90 at each visit
Proportion of subjects achieving EASI-90 at each visit
Measured: Day1-Week52
NRS score
Percent change of NRS score from baseline
Measured: Day1-Week52
BSA
Body surface area (BSA) of involvement of atopic dermatitis
Measured: Day1-Week52
DLQI
Changes from baseline in Dermatology Life Quality Index (DLQI)
Measured: Day1-Week52
Incidence of adverse events (AEs)
Incidence of adverse events (AEs), abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing
Measured: Day1-Week60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2024
- Study start4 Jul 2024
- Primary completion4 Nov 2025
- Study completion23 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 259 participants (actual)
Sponsor and investigators
- Lead sponsor
- Simcere Pharmaceutical Co., Ltd
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jianzhong Zhang, Principal investigator, Peking University People's HospitalCheng Zhou, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06477835
- Sponsor's protocol ID
- SIM0718-302
- Status last verified
- Mar 2026
- First submitted
- 14 Jun 2024
- Last updated
- 31 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of SIM0718 in Adult and Adolescent Patients With Moderate to Severe Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT06477835
- Acronym / sponsor ID
- SIM0718-302
- Conditions
- Atopic Dermatitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 259 participants (actual)
- Lead sponsor
- Simcere Pharmaceutical Co., LtdUniversity, hospital or other
- Study start
- 4 Jul 2024 (actual)
- Primary completion
- 4 Nov 2025 (actual)
- Study completion
- 23 Dec 2025 (actual)
- First posted
- 27 Jun 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 study will evaluate the efficacy and safety of SIM0718 in adolescents (12- < 18 years) and adults (18-75 years) with moderate to severe AD.
Detailed description
This is a randomized, double-blind, placebo-controlled multicenter clinical study to evaluate the efficacy and safety of SIM0718 in adolescents (12- < 18 years) and adults (18-75 years) with moderate to severe AD. Subjects who meet entry criteria will be randomized to receive either SIM0718 or matching placebo.The study includes a screening period, a treatment period and a follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test group | Active comparator | Biological: SIM0718 InjectionDuring the placebo-controlled double-blind treatment phase, subjects were randomized 1:1 to the following treatment groups: • Test group: SIM0718 300 mg SC with loading dose of 600 mg on Day 1. During the W16-W52 Maintenance Period: • All subjects were dosed SC at 300 mg SIM0718. |
| Control group | Placebo comparator | Biological: SIM0718 InjectionDuring the placebo-controlled double-blind treatment phase, subjects were randomized 1:1 to the following treatment groups: • Volume-matched placebo SC, placebo loading dose on Day 1. During the W16-W52 Maintenance Period: • All subjects were dosed SC at 300 mg SIM0718. |
Who may qualify
- Ages
- 12 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥ 12 and ≤ 75 years, male or female, and body weight ≥ 40 kg at the screening visit.
- Diagnosis of atopic dermatitis at screening (according to the American Academy of Dermatology Concordance Criteria, 2014), and: 1) Adult diagnosed AD for ≥ 12 months and adolescent diagnosed AD for ≥ 6 months prior to screening; 2) Inadequate response or intolerance to topical medications, or is medically inappropriate for topical treatment judged by the investigator within 6 months prior to Screening; 3) At Screening and Baseline,IGA score ≥3; 4)At Screening and Baseline, EASI score ≥ 16; 5) At Screening and Baseline,total AD involvement ≥ 10% BSA; 6) Baseline peak pruritus NRS score ≥ 4.
Key exclusion criteria (9 listed)
- Not enough washing-out period for previous therapy.
- History of any of the following:
- 1) History of significant immune reactions (eg, serum sickness, anaphylaxis, or delayed hypersensitivity) to any other biologic agent or any excipient of SIM0718; 2) Presence of other active skin comorbidities other than AD that may interfere with study assessments, such as scabies, skin lymphoma, or psoriasis; 3) Active keratoconjunctivitis and atopic keratoconjunctivitis at screening; or previous history of recurrent keratoconjunctivitis and atopic keratoconjunctivitis; 4) Patients with active tuberculosis (TB), latent TB, or a history of nontuberculous mycobacterial infection at screening; 5) HBsAg positive at screening; or HBcAb positive with HBV-DNA positive; or hepatitis C antibody positive with HCV RNA polymerase chain reaction positive; or HIV serology positive; 6) Systemic treatment with antibiotics, antivirals, antiparasitic agents, antiprotozoal agents, or antifungal agents for infections within 4 weeks prior to baseline, or superficial skin infections within 1 week prior to baseline that could interfere with study assessments (subjects could be re-screened after resolution of infection); 7) History of parasitic infection within 6 months prior to baseline; 8) According to the investigator 's judgment, known or suspected history of immunosuppression within 6 months prior to baseline, including but not limited to history of invasive opportunistic infections, such as aspergillosis, coccidioidomycosis, histoplasmosis, HIV, listeriosis, pneumocystis disease or tuberculosis; or the presence of abnormal frequent recurrent or persistent infections; 9) History of malignancy within 5 years prior to screening.
- 3. Planned major surgical procedures during the study.
- 4. History of alcohol or drug abuse within 2 years before screening.
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 |
|---|---|---|
| SIM0718 InjectionSubjects who meet entry criteria will be randomized in a 1:1 ratio to receive either SIM0718 or matching placebo,Q2W, SC until Week 16. At the Week 16 visit, subjects in the placebo group will be transferred to SIM0718 300 mg Q2W after completing safety and efficacy assessments. Subjects who were originally treated with 300 mg Q2W of SIM0718 will continue on their original treatment regimen. | Biological | Control group, Test group |
Primary outcome
EASI-75 at week 16
Time frame: Day1-Week16
Proportion of subjects achieving EASI-75 at week 16.
IGA score at week 16
Time frame: Day1-Week16
Proportion of subjects with IGA score of 0 or 1 and a reduction of IGA score by ≥2 points from baseline at week 16.
7 secondary outcomes
EASI-75 at each visit
Time frame: Day1-Week52
EASI-50 at each visit
Time frame: Day1-Week52
EASI-90 at each visit
Time frame: Day1-Week52
NRS score
Time frame: Day1-Week52
BSA
Time frame: Day1-Week52
DLQI
Time frame: Day1-Week52
Incidence of adverse events (AEs)
Time frame: Day1-Week60
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 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. This study is not recruiting at the moment.
Jianzhong Zhang principal investigator
Peking University People's Hospital
Cheng Zhou principal investigator
Peking University People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SIM0718 Injection in people with Atopic Dermatitis, run by Simcere 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 2 inclusion and 9 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: finished, as of the sponsor's last update on 31 Mar 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EASI-75 at week 16 (time frame: Day1-Week16). 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 31 Mar 2026.