Moderate to Severe Atopic DermatitisPhase 2NCT05997927
Efficacy and Safety Clinical Study of VC005 Tablets in Adult Patients With Moderate to Severe Atopic Dermatitis
A Phase 2 study testing VC005 tablets 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 II 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 tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 149 participants
- Where
- 1 siteChina
- Study dates
- 20 Jul 2023to 9 Jul 2024
- Phase
- Phase 2
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Male or female patients aged ≥18 and ≤75 years at the time of signing the ICF.
- Meet Hanifin-Rajka diagnostic criteria at screening and have atopic dermatitis （AD) symptoms for at least 1 year prior to baseline.
- 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).
- Recent (within 1 year prior to screening) topical treatment for AD with inadequate or intolerant clinical response, as determined by the investigator.
- Able and willing to use only stabilized doses of emollients that do not contain ingredients that interfere with the evaluation of efficacy, uniformly provided by the Sponsor, beginning at least 7 days prior to Baseline and continuing for the duration of the study.
- Non-lactating female patients of child-bearing potential (WOCBP) who have a negative pregnancy test at Screening and who are committed to adequate and effective contraception or abstinence for the duration of the study as well as for 28 days after completion of treatment with the investigational medicinal product.
- Male patients commit to use adequate and effective contraception or abstinence for the duration of the study and for 28 days after completion of treatment with the investigational drug. In addition, male patients must agree that they will not donate sperm during this period.
Who cannot join
- -
- 1. Presence of the following diseases or history of disease:
- 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;
- 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);
- Patients with prior thromboembolism (including deep vein thrombosis, pulmonary embolism, arterial thrombosis, etc.) or other high-risk groups prone to thromboembolism;
- 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;
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- History of any persistent or chronic infection at screening or prior to randomization (e.g., chronic pyelonephritis, chronic bronchitis) or presence of other infections judged unsuitable for enrollment in this study by the investigator; history of deep interstitial/tissue infections (e.g., fasciitis, abscess, osteomyelitis) within 12 months prior to baseline; history of conditionally causative bacterial infections (e.g., cytomegalovirus infections, pulmonary Aspergillosis, etc.); history of hospitalized infections (viral, bacterial, fungal, parasitic, etc.) within 3 months prior to baseline;
- Immunodeficiency diseases or first-degree relatives with hereditary immunodeficiency diseases; etc.
- 2. Any one of the laboratory test indicators at the screening test meets the following criteria:
- White blood cell count (WBC) <3×109/L, absolute neutrophil count (ANC) <1.5×109/L, absolute lymphocyte count (ALC) <0.8×109/L, platelet (PLT) <100×109/L, hemoglobin (Hb) <90 g/L; etc; 3. Being on/taking or have a history of the following treatments/medications:
- Use of systemic anti-infective drugs within 14 days prior to baseline;
- Use of any AD topical therapy, including but not limited to topical corticosteroid (TCS), topical calcineurin inhibitors (TCI), phosphodiesterase (PDE) inhibitors,Janus kinase inhibitors, within 2 weeks prior to baseline;
- Use of any kind of systemic systemic therapy for AD, including but not limited to immunosuppressants, corticosteroids, phosphodiesterase 4 (PDE4) inhibitors, and participation in other interventional clinical trials with an indication of AD within 4 weeks (or 5 t1/2, whichever is longer) prior to Baseline;
- Subjects with a positive test result on the gamma-interferon (IFN-γ) release assay (QUANTIFERON®-TB GOLD or T-SPOT.TB®) at Screening, with the exception of those who, in the judgment of the Investigator, require prophylaxis and have been on prophylaxis for ≥ 4 weeks.
- 5. Substantial blood loss, receipt of blood transfusion, or blood donation (≥400 mL) within 3 months prior to baseline.
- 6、 Known or suspected allergy to the main components and excipients of VC005 or similar drugs.
- 7. Women who are planning to become pregnant, pregnant or breastfeeding. 8, History of alcohol abuse [>14 units of alcohol per week (1 unit of alcohol ≈ 360 mL of beer or 45 mL of spirits with 40% alcohol content or 150 mL of wine)] in the 6 months prior to baseline that cannot be stopped during the trial.
- 9. Patients who, in the judgment of the investigator, have other reasons that make them unsuitable for participation in this clinical trial.
Trial locations and contacts
1 site in 1 country.
China1 site
Chinese Academy of Medical Sciences Hospital for Skin Diseases
Nanjing, Jiangsu, 210042
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II 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 II clinical study.
- Conditions
- Moderate to Severe Atopic Dermatitis
- Being tested
- VC005 tablets, VC005 Tablets Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VC005 tabletsDrug
VC005 groups repeat administration for 12 weeks
VC005 Tablets PlaceboDrug
VC005 placebo groups repeat administration for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| VC005 Tablets Low Dose groups | Experimental | Not described Receives: Drug: VC005 tablets; Drug: VC005 Tablets Placebo |
| VC005 Tablets Medium Dose groups | Experimental | Not described Receives: Drug: VC005 tablets; Drug: VC005 Tablets Placebo |
| VC005 Tablets High Dose groups | Experimental | Not described Receives: Drug: VC005 tablets; Drug: VC005 Tablets Placebo |
| VC005 Tablets Placebo groups | Placebo comparator | Not described Receives: Drug: VC005 Tablets Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change from baseline in EASI score
Percentage change from baseline in EASI score at week 12
Measured: week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2023
- Study start20 Jul 2023
- Primary completion9 Jul 2024
- Study completion9 Jul 2024
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 149 participants (actual)
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
- NCT05997927
- Sponsor's protocol ID
- VC005-202
- Status last verified
- Jul 2024
- First submitted
- 10 Aug 2023
- Last updated
- 29 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of VC005 Tablets in Adult Patients With Moderate to Severe Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT05997927
- Acronym / sponsor ID
- VC005-202
- Conditions
- Moderate to Severe Atopic Dermatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Jiangsu vcare pharmaceutical technology co., LTDIndustry (pharma, biotech, devices)
- Study start
- 20 Jul 2023 (actual)
- Primary completion
- 9 Jul 2024 (actual)
- Study completion
- 9 Jul 2024 (actual)
- First posted
- 18 Aug 2023 (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 II clinical study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| VC005 Tablets Low Dose groups | Experimental | Drug: VC005 tablets, Drug: VC005 Tablets Placebo |
| VC005 Tablets Medium Dose groups | Experimental | Drug: VC005 tablets, Drug: VC005 Tablets Placebo |
| VC005 Tablets High Dose groups | Experimental | Drug: VC005 tablets, Drug: VC005 Tablets Placebo |
| VC005 Tablets Placebo groups | Placebo comparator | Drug: VC005 Tablets Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
- Male or female patients aged ≥18 and ≤75 years at the time of signing the ICF.
- Meet Hanifin-Rajka diagnostic criteria at screening and have atopic dermatitis （AD) symptoms for at least 1 year prior to baseline.
- 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).
- 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 (18 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;
- 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);
- Patients with prior thromboembolism (including deep vein thrombosis, pulmonary embolism, arterial thrombosis, etc.) or other high-risk groups prone to thromboembolism;
- 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 tabletsVC005 groups repeat administration for 12 weeks | Drug | VC005 Tablets High Dose groups, VC005 Tablets Low Dose groups, VC005 Tablets Medium Dose groups |
| VC005 Tablets PlaceboVC005 placebo groups repeat administration for 12 weeks | Drug | VC005 Tablets High Dose groups, VC005 Tablets Low Dose groups, VC005 Tablets Medium Dose groups, VC005 Tablets Placebo groups |
Primary outcome
Percentage change from baseline in EASI score
Time frame: week 12
Percentage change from baseline in EASI score at week 12
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 29 Jul 2024.
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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.
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 2 study testing VC005 tablets 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 8 inclusion and 18 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 29 Jul 2024. 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?
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?
Percentage change from baseline in EASI score (time frame: week 12). 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 Jul 2024.