Atopic DermatitisPhase 2NCT07054736
Evaluate the Efficacy and Safety of XKH001 Injection in Patients With Moderate-to-Severe Atopic Dermatitis
A Phase 2 study testing XKH001 Injection in people with Atopic Dermatitis, run by Zhejiang Kanova Biopharmaceutical Co., LTD at 1 site in China.
Trial summary
This study will be a multicenter, randomized, double-blinded, placebo-controlled clinical study. It is planned to enroll 120 adult patients with moderate-to-severe Atopic Dermatitis whose disease cannot be adequately controlled with topical medications or for whom topical treatments are medically inadvisable. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- XKH001 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 31 Aug 2025to 1 Dec 2025
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must meet all the following criteria to be eligible for participation in this study:
- Both males and females, aged 18 to 65 years (inclusive) on the day of signing the informed consent;
- Diagnosed with Atopic dermatitis according to the American Academy of Dermatology consensus criteria (2014) and with a history of disease for at least 6 months prior to signing the informed consent;
- At the screening and baseline visits, the severity of Atopic dermatitis is classified as moderate to severe, that is, the following 4 conditions are met simultaneously; Eczema Area and Severity Index (EASI) score ≥ 16 points; Investigator's Global Assessment (IGA) score ≥ 3 points; Percent Body Surface Area (BSA) ≥10%; Weekly mean of daily Peak Pruritus Numerical Rating Scale (NRS) score ≥ 4 points;
- If the investigator determines that topical drug therapy used within 6 months prior to signing the informed consent was insufficiently effective or unsuitable, at least one of the following conditions must be met:
- Received ≥ 4 weeks of medium/potent topical corticosteroids (TCSs) or ≥ 2 weeks of super potent TCSs (combined with the longest treatment course recommended in the drug instructions, whichever is shorter) ± topical calcineurin inhibitors (TCIs), but did not achieve and maintain remission or a lower disease activity state (equivalent to IGA = 0 to 2); Received systemic corticosteroids (SCSs) and other systemic treatments for AD is also considered an insufficient response to topical drug therapy; Not suitable for topical drug therapy (e.g., intolerance or contraindications);
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- Application of a stable dose of basic, mild, inactive ingredient-free topical emollients (moisturizers) twice daily for at least 7 consecutive days before the first dose and throughout the study.
- Subjects of childbearing potential and their partners must voluntarily use effective contraceptive methods during the study and continue for 6 months after the final dose; Note: Women of childbearing potential are those who have not undergone sterilization and either have not yet experienced menopause, have experienced menopause for less than 1 year, or have been menopausal for 1 year or more but have pathological conditions affecting menopause. Such women are considered to have potential fertility.
- Subjects must voluntarily sign the informed consent before any study-related procedures begin, be able to communicate effectively with the investigator, and understand and agree to adhere strictly to the protocol requirements.
Who cannot join
- Subjects who meet any of the following criteria should not be enrolled in this study:
- Previous treatment with biological agents for Atopic dermatitis (e.g., dupilumab, tralokinumab), XKH001, or drugs with the same target (including investigational products);
- Allergen-specific immunization therapy for Atopic dermatitis within 6 months prior to the first dose;
- Systemic drug therapy for Atopic dermatitis within 4 weeks prior to the first dose:
- Systemic corticosteroids (SCS); Immunosuppressants/immunomodulators (e.g., cyclosporin, mycophenolate mofetil, interferon-γ (IFN-γ), Janus kinase (JAK) inhibitors, azathioprine, methotrexate); Traditional Chinese medicine (including modern Chinese medicine preparations) for Atopic dermatitis treatment;
- Ultraviolet for Atopic dermatitis (including but not limited to narrow-band ultraviolet B (NB-UVB) and medium-to-high dose UVA1) within 4 weeks prior to the first dose;
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- Treatment with prescription emollients or emollients containing active ingedients (e.g., ceramide, hyaluronic acid, urea, or filaggrin breakdown products) initiated during the screening period (if such emollients are used prior to signing the informed consent, they can be continued at a stable dose);
- ≥3 times of bleach bath therapy for Atopic dermatitis in any week within 4 weeks prior to the first dose;
- The following topical drug therapy for Atopic dermatitis within 2 weeks prior to the first dose:
- TCS or TCI; Other topical drugs: including but not limited to topical phosphodiesterase 4 (PDE-4) inhibitors (e.g., Crisaborole), JAK inhibitors (e.g., Ruxolitinib), traditional Chinese medicine (including modern Chinese medicine preparations);
- Treatment with other biological agents within 5 half-lives (if known) or 16 weeks (whichever is longer) prior to the first dose;
- Treatment with the investigational products (XKH001 or drugs with the same target, see Exclusion Criterion 1) or device therapy within 8 weeks or 5 half-lives (whichever is longer) prior to the first dose.
- Known or suspected history of immunosuppressive diseases, including history of invasive opportunistic infections (such as tuberculosis (TB), histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis), even if the infection has resolved/subsided; or abnormally frequent, recurrent, or prolonged infections as determined by the investigator (Note: Confirmed/suspected active or therapy naive latent TB must be excluded);
- Chronic active or acute infection requiring systemic treatment with antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks prior to the first dose; or superficial skin infection within 1 week prior to the first dose (Note: Subjects can be re-screened after the infection has resolved);
- Uncontrolled chronic diseases requiring extensive use of SCS, such as uncontrolled severe asthma (defined as ACQ-5 score ≥1.5 or history of ≥ 2 SCS use or hospitalization > 24 hours for asthmatic attack in the 12 months prior to signing the informed consent);
- Laboratory test abnormal within 7 days prior to the first dose:
- Hemoglobin (HGB) <90 g/L; Leukocyte count (WBC) <3.0×109/L; Absolute neutrophil count (ANC) <1.5×109/L; Platelet count (PLT) <90×109/L; Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 × upper limit of normal (ULN); Bilirubin total (TBIL) > 1.5 ×ULN (subjects with Gilbert syndrome >3 × ULN); Creatinine clearance (CrCl) < 50 mL/min (Cockcroft-Gault formula);
- Positive for hepatitis B surface antigen (HBsAg), or negative for HBsAg but positive for hepatitis B core antibody (HBcAb) and HBV-DNA > ULN, positive for antibody to hepatitis C virus (anti-HCV) and positive for HCV-RNA;
- History of human immunodeficiency virus (HIV) infection or positive serum HIV antibody;
- Other skin diseases that may interfere with the investigator's assessment during the screening period;
- History of neoplasm malignant within 5 years prior to signing informed consent (except for cured squamous cell carcinoma of skin in situ and basal cell carcinoma, and cured cervical carcinoma in situ);
- Diagnosed with active or suspected parasitic infection,, or at high risk of infection before the first administration: Unless clinical judgment (laboratory test assessment if necessary) has ruled out active infection;
- Combined with various serious diseases that the investigator judges may affect the patient's participation in this study, including but not limited to: Diseases that seriously affect survival, uncontrolled diabetes mellitus, ≥ Grade 2 (CTCAE 5.0) dyslipidaemia of all types (attention should be paid to excluding the influence of physiological factors such as diet), New York Heart Association (NYHA) Class 3 to 4 cardiac insufficiency, renal insufficiency requiring dialysis, Child-Pugh Class B/C liver function, demyelination diseases, active autoimmune diseases;
- History of mental disorder; Individuals with a history of significant mental health disorders that may affect their ability to comply with the study requirements; in addition, patients with severe anxiety or depression or suicidal ideology/behavior in the preceding 6 months will be excluded;
- History of alcohol abuse or various drug abuse within 2 years prior to signing informed consent;
- Vaccinated with attenuated live/live vaccine (including investigational vaccines) within 12 weeks prior to the first administration, or planning to be vaccinated with attenuated live/live vaccine during the study;
- Major surgery (craniotomy, thoracotomy, laparotomy, etc.) within 4 weeks prior to the first administration, or planning to undergo major surgery during the study;
- Within 2 weeks prior to the first administration, there is severe blood loss (total blood volume ≥ 500 mL), or received blood products, hematopoietic growth factors (e.g. granulocyte colony-stimulating factor G-CSF), albumin infusion;
- Women who are known to be pregnant or have childbearing potential have a positive serum human chorionic gonadotropin (HCG) test at screening, or are breastfeeding, or are planning to become pregnant or breastfeed during the study;
- Subjects with known allergy to the study drug, any ingredient in the study drug formulation, or history of allergy to protein drugs;
- Other conditions that the investigator considers unsuitable for participation in this study;
- Subjects who are currently enrolled in another clinical trial or investigational 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
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 2 Clinical Study to Evaluate the Efficacy and Safety of XKH001 Injection in Patients With Moderate-to-Severe Atopic Dermatitis
This study will be a multicenter, randomized, double-blinded, placebo-controlled clinical study. It is planned to enroll 120 adult patients with moderate-to-severe Atopic Dermatitis whose disease cannot be adequately controlled with topical medications or for whom topical treatments are medically inadvisable.
Read the detailed description
This study will be a multicenter, randomized, double-blinded, placebo-controlled clinical study. It is planned to enroll 120 adult patients with moderate-to-severe Atopic Dermatitis whose disease cannot be adequately controlled with topical medications or for whom topical treatments are medically inadvisable. With the disease severity assessed at the baseline visit-IGA: 3 points (moderate) vs. 4 points (severe) used as the stratification factors, a central randomization system will be used to randomly assign the patients to 3 dose groups of the study drug XKH001 (100 mg quaque 4 weeks , 300 mg quaque 4 weeks , 600 mg quaque 4 weeks ) and the placebo group in a 1:1:1:1 ratio, with 30 patients in each group.
This study aims to evaluate the safety, efficacy, PK and PD characteristics, and immunogenicity of XKH001 in adult patients with moderate-to-severe Atopic Dermatitis.
- Conditions
- Atopic Dermatitis
- Being tested
- XKH001 Injection, XKH001 Placebo Injection
- Keywords
- Atopic Dermatitis
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XKH001 InjectionDrug
100 mg quaque 4 weeks dose group: Subjects will receive 1 mL (1 vial) of XKH001 injection (100 mg) and 5 mL (5 vials) of placebo injection subcutaneously each time, once every 4 weeks, for a total of 5 times.
300 mg quaque 4 weeks dose group: Subjects will receive 3 mL (3 vials) of XKH001 injection (300 mg) and 3 mL (3 vials) of placebo injection subcutaneously each time, once every 4 weeks, for a total of 5 times.
600 mg quaque 4 weeks dose group: Subjects will receive 6 mL (6 vials) of XKH001 injection (600 mg) subcutaneously each time, once every 4 weeks, for a total of 5 times.
XKH001 Placebo InjectionDrug
Subjects will receive 6 mL (6 vials) of placebo injection subcutaneously each time, once every 4 weeks, for a total of 5 times.
| Study group | Role | What they receive |
|---|---|---|
| 100mg | Active comparator | 100mg,quaque 4 weeks Receives: Drug: XKH001 Injection; Drug: XKH001 Placebo Injection |
| 300mg | Active comparator | 300mg,quaque 4 weeks Receives: Drug: XKH001 Injection; Drug: XKH001 Placebo Injection |
| 600mg | Active comparator | 600mg,quaque 4 weeks Receives: Drug: XKH001 Injection; Drug: XKH001 Placebo Injection |
| Placebo | Placebo comparator | Placebo,quaque 4 weeks Receives: Drug: XKH001 Placebo Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Objective1
Proportion of subjects with an Investigator's Global Assessment (IGA) score of 0 or 1 (clear or almost clear) and a reduction of ≥2 points from baseline to Week 16.
Measured: Week16
Primary Objective2
Proportion of subjects with Treatment Emergent Serious Adverse Events (TESAEs) from baseline to Week 16
Measured: Week16
Secondary outcomes (6)
Secondary Objective1
Proportion of subjects with improvement (Reduction ≥4 Points) of Pruritus Numerical Rating Scale (NRS) Score from baseline to Week 16
Measured: Week16
Secondary Objective2
Percent change from baseline in Peak Daily Pruritus Numerical Rating Scale (NRS) Score to Week 16
Measured: Week16
Secondary Objective3
Proportion of subjects with improvement (Reduction
≥4 Points) of Pruritus Numerical Rating Scale (NRS) Score from baseline to Week 4
Measured: Week4
Secondary Objective4
Change from baseline in percent Body Surface Area (BSA) affected at Weeks 4, 8, 12, 16, 20, 24, and 28;
Measured: Weeks 4, 8, 12, 16, 20, 24, and 28;
Secondary Objective5
Percent change from baseline in IGA 0/1 and reduction of ≥ 2, mean EASI score and weekly average of peak daily Pruritus Numeric Rating Scale (NRS) at Weeks 4, 8, 12, 16, 20, 24, and 28;
Measured: Weeks 4, 8, 12, 16, 20, 24, and 28;
Secondary Objective6
Percent change in AD specific symptomatic and quality of life (QOL) assessment with AD control tool (ADCT) from baseline to weeks 4, 8, 12, 16, 20, 24
Measured: weeks 4, 8, 12, 16, 20, 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study start31 Aug 2025 (estimated)
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- a central randomization system will be used to randomly assign the patients to 3 dose groups of the study drug XKH001 (100 mg quaque 4 weeks , 300 mg quaque 4 weeks , 600 mg quaque 4 weeks ) and the placebo group in a 1:1:1:1 ratio, with 30 patients in each group.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Kanova Biopharmaceutical Co., LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jianzhong Zhang, Dr, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07054736
- Sponsor's protocol ID
- XKH001-01-II
- Status last verified
- Jun 2025
- First submitted
- 23 Dec 2024
- Last updated
- 8 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 2 Clinical Study to Evaluate the Efficacy and Safety of XKH001 Injection in Patients With Moderate-to-Severe Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT07054736
- Acronym / sponsor ID
- XKH001-01-II
- Conditions
- Atopic Dermatitis
- Keywords
- Atopic Dermatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Zhejiang Kanova Biopharmaceutical Co., LTDIndustry (pharma, biotech, devices)
- Study start
- 31 Aug 2025 (estimated)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 8 Jul 2025 (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 be a multicenter, randomized, double-blinded, placebo-controlled clinical study. It is planned to enroll 120 adult patients with moderate-to-severe Atopic Dermatitis whose disease cannot be adequately controlled with topical medications or for whom topical treatments are medically inadvisable.
Detailed description
This study will be a multicenter, randomized, double-blinded, placebo-controlled clinical study. It is planned to enroll 120 adult patients with moderate-to-severe Atopic Dermatitis whose disease cannot be adequately controlled with topical medications or for whom topical treatments are medically inadvisable. With the disease severity assessed at the baseline visit-IGA: 3 points (moderate) vs. 4 points (severe) used as the stratification factors, a central randomization system will be used to randomly assign the patients to 3 dose groups of the study drug XKH001 (100 mg quaque 4 weeks , 300 mg quaque 4 weeks , 600 mg quaque 4 weeks ) and the placebo group in a 1:1:1:1 ratio, with 30 patients in each group.
This study aims to evaluate the safety, efficacy, PK and PD characteristics, and immunogenicity of XKH001 in adult patients with moderate-to-severe Atopic Dermatitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- a central randomization system will be used to randomly assign the patients to 3 dose groups of the study drug XKH001 (100 mg quaque 4 weeks , 300 mg quaque 4 weeks , 600 mg quaque 4 weeks ) and the placebo group in a 1:1:1:1 ratio, with 30 patients in each group.
| Arm | Type | Receives |
|---|---|---|
| 100mg | Active comparator | Drug: XKH001 Injection, Drug: XKH001 Placebo Injection100mg,quaque 4 weeks |
| 300mg | Active comparator | Drug: XKH001 Injection, Drug: XKH001 Placebo Injection300mg,quaque 4 weeks |
| 600mg | Active comparator | Drug: XKH001 Injection, Drug: XKH001 Placebo Injection600mg,quaque 4 weeks |
| Placebo | Placebo comparator | Drug: XKH001 Placebo InjectionPlacebo,quaque 4 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subjects must meet all the following criteria to be eligible for participation in this study:
- Received ≥ 4 weeks of medium/potent topical corticosteroids (TCSs) or ≥ 2 weeks of super potent TCSs (combined with the longest treatment course recommended in the drug instructions, whichever is shorter) ± topical calcineurin inhibitors (TCIs), but did not achieve and maintain remission or a lower disease activity state (equivalent to IGA = 0 to 2); Received systemic corticosteroids (SCSs) and other systemic treatments for AD is also considered an insufficient response to topical drug therapy; Not suitable for topical drug therapy (e.g., intolerance or contraindications);
Key exclusion criteria (32 listed)
- Subjects who meet any of the following criteria should not be enrolled in this study:
- Systemic corticosteroids (SCS); Immunosuppressants/immunomodulators (e.g., cyclosporin, mycophenolate mofetil, interferon-γ (IFN-γ), Janus kinase (JAK) inhibitors, azathioprine, methotrexate); Traditional Chinese medicine (including modern Chinese medicine preparations) for Atopic dermatitis treatment;
- TCS or TCI; Other topical drugs: including but not limited to topical phosphodiesterase 4 (PDE-4) inhibitors (e.g., Crisaborole), JAK inhibitors (e.g., Ruxolitinib), traditional Chinese medicine (including modern Chinese medicine preparations);
- Hemoglobin (HGB) <90 g/L; Leukocyte count (WBC) <3.0×109/L; Absolute neutrophil count (ANC) <1.5×109/L; Platelet count (PLT) <90×109/L; Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 × upper limit of normal (ULN); Bilirubin total (TBIL) > 1.5 ×ULN (subjects with Gilbert syndrome >3 × ULN); Creatinine clearance (CrCl) < 50 mL/min (Cockcroft-Gault formula);
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 |
|---|---|---|
| XKH001 Injection100 mg quaque 4 weeks dose group: Subjects will receive 1 mL (1 vial) of XKH001 injection (100 mg) and 5 mL (5 vials) of placebo injection subcutaneously each time, once every 4 weeks, for a total of 5 times. 300 mg quaque 4 weeks dose group: Subjects will receive 3 mL (3 vials) of XKH001 injection (300 mg) and 3 mL (3 vials) of placebo injection subcutaneously each time, once every 4 weeks, for a total of 5 times. 600 mg quaque 4 weeks dose group: Subjects will receive 6 mL (6 vials) of XKH001 injection (600 mg) subcutaneously each time, once every 4 weeks, for a total of 5 times. | Drug | 100mg, 300mg, 600mg |
| XKH001 Placebo InjectionSubjects will receive 6 mL (6 vials) of placebo injection subcutaneously each time, once every 4 weeks, for a total of 5 times. | Drug | 100mg, 300mg, 600mg, Placebo |
Primary outcome
Primary Objective1
Time frame: Week16
Proportion of subjects with an Investigator's Global Assessment (IGA) score of 0 or 1 (clear or almost clear) and a reduction of ≥2 points from baseline to Week 16.
Primary Objective2
Time frame: Week16
Proportion of subjects with Treatment Emergent Serious Adverse Events (TESAEs) from baseline to Week 16
6 secondary outcomes
Secondary Objective1
Time frame: Week16
Secondary Objective2
Time frame: Week16
Secondary Objective3
Time frame: Week4
Secondary Objective4
Time frame: Weeks 4, 8, 12, 16, 20, 24, and 28;
Secondary Objective5
Time frame: Weeks 4, 8, 12, 16, 20, 24, and 28;
Secondary Objective6
Time frame: weeks 4, 8, 12, 16, 20, 24
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 8 Jul 2025.
- 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.
Jianzhong Zhang, Dr 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 2 study testing XKH001 Injection in people with Atopic Dermatitis, run by Zhejiang Kanova Biopharmaceutical 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 9 inclusion and 32 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: opening soon, as of the sponsor's last update on 8 Jul 2025. 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 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 Jianzhong Zhang, Dr (010-88325471, rmzjz@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Objective1 (time frame: 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 8 Jul 2025.