Moderate to Severe Atopic DermatitisPhase 3NCT06723080
Phase III Clinical Study of VC005 Tablets in Adult Patients With Moderate to Severe Atopic Dermatitis
A Phase 3 study testing VC005 low dose group and VC005 high dose group in people with Moderate to Severe Atopic Dermatitis, run by Jiangsu vcare pharmaceutical technology co., LTD at 1 site in China.
Trial summary
This clinical trial is a multicenter, randomized, double-blind, controlled phase III clinical study Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Moderate to Severe Atopic Dermatitis
- What is being tested?
- VC005 low dose group and VC005 high dose group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 480 participants
- Where
- 1 siteChina
- Study dates
- 30 Dec 2024to 30 Aug 2027
- Phase
- Phase 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (1）The patient understands and voluntarily signs the Informed Consent Form (ICF), and has the willingness and ability to complete the regular visits,treatment plans, laboratory tests and other experimental procedures required by the program. (2) Male or female patients aged ≥18 and ≤75 years at the time of signing the ICF. (3) Meet Hanifin-Rajka diagnostic criteria at screening and have atopic dermatitis （AD) symptoms for at least 1 year prior to baseline. (4) At screening and baseline, meets criteria for moderately severe AD based on the investigator's assessment of 3 of the following:Eczema area and severity index (EASI) score ≥12;Psoriasis Area Severity Index (IGA) score ≥3;AD involvement in ≥10% of the Body Surface Area (BSA). (5) Recent (within 1 year prior to screening) topical treatment for AD with inadequate or intolerant clinical response, as determined by the investigator
Who cannot join
- Inability to swallow the test drug or refractory nausea and vomiting, malabsorption, extracorporeal biliary shunt, or the presence of a gastrointestinal disorder (e.g., Crohn's disease, ulcerative colitis, or short bowel syndrome) or other malabsorption condition that interferes with the absorption of the drug; (2) Current or history of lymphoproliferative disorders or presence of signs or symptoms suggestive of possible lymphoproliferative disorders of lymphoid tissue, including lymphadenopathy or splenomegaly; malignancies of any kind, or a history of any malignancy within the 5 years prior to Screening (except for completely resected carcinoma in situ of the cervix or non-metastatic squamous cell or basal cell carcinoma of the skin or papillary carcinoma of the thyroid gland); (3) Patients with prior thromboembolism (including deep vein thrombosis, pulmonary embolism, arterial thrombosis, etc.) or other high-risk groups prone to thromboembolism; (4) Patients with a history of herpes virus infection within the last 1 month or those with recurrent episodes of herpes zoster (≥2), disseminated herpes zoster, disseminated herpes simplex, or those for whom herpes zoster or herpes simplex infections cannot be excluded at this time;
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
Chinese Academy of Medical Sciences Hospital for Skin Diseases
Nanjing, Jiangsu, 210042
Jin Nie
qianjin Lu
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of VC005 Tablets in Adult Patients With Moderate to Severe Atopic Dermatitis
This clinical trial is a multicenter, randomized, double-blind, controlled phase III clinical study
- Conditions
- Moderate to Severe Atopic Dermatitis
- Being tested
- VC005 low dose group, VC005 high dose group, VC005 Placebo group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VC005 low dose groupDrug
VC005 low dose group repeat administration
VC005 high dose groupDrug
VC005 high dose group repeat administration
VC005 Placebo groupDrug
VC005 Placebo group repeat administration
| Study group | Role | What they receive |
|---|---|---|
| VC005 low dose group | Experimental | Not described Receives: Drug: VC005 low dose group |
| VC005 high dose group | Experimental | Not described Receives: Drug: VC005 high dose group |
| VC005 placebo group | Placebo comparator | Not described Receives: Drug: VC005 Placebo group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects achieving at least a 75% reduction in Eczema Area and Severity Index (EASI 75) from Baseline at Week 16
Measured: week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start30 Dec 2024
- Primary completion30 Aug 2027 (estimated)
- Study completion30 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate to Severe Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by Jiangsu vcare pharmaceutical technology 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu vcare pharmaceutical technology co., LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- qianjin Lu, Principal investigator, Chinese Academy of Medical Sciences Hospital of Skin Disease
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06723080
- Sponsor's protocol ID
- VC005-302
- Status last verified
- Jul 2026
- First submitted
- 5 Dec 2024
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of VC005 Tablets in Adult Patients With Moderate to Severe Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT06723080
- Acronym / sponsor ID
- VC005-302
- Conditions
- Moderate to Severe Atopic Dermatitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Jiangsu vcare pharmaceutical technology co., LTDIndustry (pharma, biotech, devices)
- Study start
- 30 Dec 2024 (actual)
- Primary completion
- 30 Aug 2027 (estimated)
- Study completion
- 30 Aug 2027 (estimated)
- First posted
- 9 Dec 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 clinical trial is a multicenter, randomized, double-blind, controlled phase III clinical study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| VC005 low dose group | Experimental | Drug: VC005 low dose group |
| VC005 high dose group | Experimental | Drug: VC005 high dose group |
| VC005 placebo group | Placebo comparator | Drug: VC005 Placebo group |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- (1）The patient understands and voluntarily signs the Informed Consent Form (ICF), and has the willingness and ability to complete the regular visits,treatment plans, laboratory tests and other experimental procedures required by the program. (2) Male or female patients aged ≥18 and ≤75 years at the time of signing the ICF. (3) Meet Hanifin-Rajka diagnostic criteria at screening and have atopic dermatitis （AD) symptoms for at least 1 year prior to baseline. (4) At screening and baseline, meets criteria for moderately severe AD based on the investigator's assessment of 3 of the following:Eczema area and severity index (EASI) score ≥12;Psoriasis Area Severity Index (IGA) score ≥3;AD involvement in ≥10% of the Body Surface Area (BSA). (5) Recent (within 1 year prior to screening) topical treatment for AD with inadequate or intolerant clinical response, as determined by the investigator
Key exclusion criteria (1 listed)
- Inability to swallow the test drug or refractory nausea and vomiting, malabsorption, extracorporeal biliary shunt, or the presence of a gastrointestinal disorder (e.g., Crohn's disease, ulcerative colitis, or short bowel syndrome) or other malabsorption condition that interferes with the absorption of the drug; (2) Current or history of lymphoproliferative disorders or presence of signs or symptoms suggestive of possible lymphoproliferative disorders of lymphoid tissue, including lymphadenopathy or splenomegaly; malignancies of any kind, or a history of any malignancy within the 5 years prior to Screening (except for completely resected carcinoma in situ of the cervix or non-metastatic squamous cell or basal cell carcinoma of the skin or papillary carcinoma of the thyroid gland); (3) Patients with prior thromboembolism (including deep vein thrombosis, pulmonary embolism, arterial thrombosis, etc.) or other high-risk groups prone to thromboembolism; (4) Patients with a history of herpes virus infection within the last 1 month or those with recurrent episodes of herpes zoster (≥2), disseminated herpes zoster, disseminated herpes simplex, or those for whom herpes zoster or herpes simplex infections cannot be excluded at this time;
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 |
|---|---|---|
| VC005 low dose groupVC005 low dose group repeat administration | Drug | VC005 low dose group |
| VC005 high dose groupVC005 high dose group repeat administration | Drug | VC005 high dose group |
| VC005 Placebo groupVC005 Placebo group repeat administration | Drug | VC005 placebo group |
Primary outcome
Proportion of subjects achieving at least a 75% reduction in Eczema Area and Severity Index (EASI 75) from Baseline at Week 16
Time frame: week 16
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 27 Jul 2026.
Related trials for Moderate to Severe Atopic Dermatitis
Not yet recruitingPhase 1
A Study of HSK60002 Tablets in Participants With Moderate-to-Severe Atopic Dermatitis
Dermatitis Atopic
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to Severe Eczema
Atopic Dermatitis
RecruitingPhase 3
Roflumilast Cream 0.3% for Moderate to Severe Atopic Dermatitis
Atopic Dermatitis, Atopic Dermatitis (AD)
RecruitingPhase 3
A Long-term Study of the Medicine Called Abrocitinib in Children Aged 2 Years and Older With Moderate to Severe Eczema
Atopic Dermatitis
RecruitingPhase 2
A Study to Learn About Study Medicine Called PF-08049820 in People With Eczema
Atopic Dermatitis, Eczema, Atopic
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.
qianjin Lu principal investigator
Chinese Academy of Medical Sciences Hospital of Skin Disease
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 VC005 low dose group and VC005 high dose group in people with Moderate to Severe Atopic Dermatitis, run by Jiangsu vcare pharmaceutical technology 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 1 inclusion and 1 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 27 Jul 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?
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 xiaojuan Lai (15358160458, lai_xiaojuan@vcarepharmatech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects achieving at least a 75% reduction in Eczema Area and Severity Index (EASI 75) from Baseline at Week 16 (time frame: week 16). 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 27 Jul 2026.