PsoriasisPhase 2NCT06170840
A Study of QY101 Ointment in Subjects With Plaque Psoriasis
A Phase 2 study of Psoriasis, run by E-nitiate Biopharmaceuticals (Hangzhou) Co., Ltd. at 1 site in China.
Trial summary
The goal of this clinical trial is to evaluate the effectiveness of QY101 ointment in adult patients with plaque psoriasis (2-20% BSA). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Psoriasis
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 17 May 2023to 30 Apr 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
- Be able to understand and comply with the test process, voluntarily participate in the test and provide informed consent;
- When signing the informed consent, age ≤ 18 years old ≤ 75 years old, gender is not limited;
- The patient meets the diagnosis of plaque psoriasis, has a history of plaque psoriasis for ≥ 6 months before randomization, and meets the following conditions:
- At baseline, plaque psoriasis covered 2% to 20% of BSA (including both ends) (scalp, palms, and soles were not counted as BSA);
- Physician overall assessment (PGA) ≥ 2 at baseline;
- Fertile men and women of childbearing age must agree to use reliable contraception from the time they sign an informed consent until six months after the last dose of the investigational drug; Blood pregnancy tests for women of childbearing age must be negative during screening and at baseline.
Who cannot join
- Other types of psoriasis were diagnosed during screening, such as gutting psoriasis, erythrodermic psoriasis, generalized pustular psoriasis, arthropathic psoriasis, drug-induced or drug-aggravated psoriasis;
- The presence of other systemic autoimmune inflammatory diseases and skin lesions (such as eczema), which may affect the evaluation of treatment outcomes;
- Subjects who are expected to receive additional local therapy, phototherapy, or other systemic therapy other than investigational medication during the trial;
- Taking drugs that can aggravate psoriasis (such as lithium, antimalarial drugs, etc.);
- Patients who have failed or are intolerant to previous treatment with Phosphodiesterase-4 (PDE4) inhibitors;
- Known to be allergic to the study drug or related excipients (QY101 ointment and excipients: albuvarin, light liquid paraffin, propylene glycol, Carbonic acid, glyceryl behenate, glyceryl monodistearate, hydroxyphenyl butyl, propyl gallate and disodium edetate), or have a history of angioedema or allergy to topical drugs;
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- receive contraindicated drugs, supplements, and other treatments prescribed in this trial that may affect the course of psoriasis within the specified time period prior to initial dosing or planned for the duration of the trial (see Appendix 2: Concomitant medications during the trial);
- Participants who are participating in another interventional clinical trial or whose last use of another investigational drug is less than 5 half-lives prior to the first dosing of the investigational drug;
- any history of infection or recurrent infection requiring systemic antibiotic treatment within 2 weeks prior to first dosing, or serious infection requiring hospitalization or intravenous antibiotic treatment within 8 weeks prior to first dosing (e.g., pneumonia, cellulitis, bone or joint infection, etc.); Recurrent, chronic, or other active infection at the time of initial dosing, if the investigator determines that participation in the study increases participants' risk;
- Use of a suppressant of CYP3A liver metabolic enzyme, or use of any medication, including prescription, over-the-counter, and herbal oral or topical drugs, other than vitamins and/or Paracetamol, within 2 weeks prior to initial administration;
- Participants who have received, or plan to receive, a live or attenuated vaccine within 4 weeks prior to initial administration;
- Abnormal laboratory test results during screening, including:
- Alanine aminotransferase (ALT), aspartate aminotransferase (AST) or basic phosphoric acid
- Enzyme (ALP) > 2.5 × Upper Limit of Normal (ULN);
- Serum creatinine > 1.5×ULN, or creatinine clearance < 50 mL/min.
- Hepatitis B surface antigen (HBsAg) positive or hepatitis B core antibody (HBcAb) positive, and hepatitis B virus deoxyribonucleic acid (HBV-DNA) positive; Or hepatitis C virus (HCV) antibody positive and HCV-RNA positive; Or positive for HIV, Treponema Pallidum-Antibody (TP-Ab) (Rapid Plasma Reagin, TP-AB) RPR] or Toluidine Red Unheated Serum Test (except for negative Toluidine Red Unheated Serum Test, TRUST);
- The presence of decompensated cardiac insufficiency (New York Heart Disease Assocation (NYHA) class III or IV) within 6 months prior to screening; History of unstable angina pectoris, myocardial infarction, coronary artery bypass grafting or coronary stent implantation; There are severe arrhythmias that require medication or cardiac assistance, such as degree II type 2 or degree III atrioventricular block, long QT Interval, or long QT block. QT syndrome or Fridericia Corrected QT Interval (QTcF) abnormality (male > 470 ms female > 480 ms) corrected according to the Fridericia formula and assessed by the investigator as unsuitable for participation in this clinical trial; Hospitalization due to Cardiovascular (CV) events, CV disease or CV surgery; Peripheral artery disease diagnosed by angiography with stroke (ischemic or hemorrhagic, including transient ischemic attack) should be excluded;
- Known malignant tumors or history of malignant tumors (excluding clinically cured skin basal cell carcinoma, skin squamous cell carcinoma, cervical carcinoma in situ);
- Patients with psychoneuro-related diseases or history (such as depression, epilepsy), which affect medication compliance or the researcher's clinical judgment of suicide risk;
- Pregnant or lactating women, female subjects or male subjects' partners planning to become pregnant (within 6 months after signing the informed consent to the last administration of the study drug);
- Other conditions deemed unsuitable for participation in this study by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Skin Disease Hospital
Shanghai, Shanghai Municipality
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of QY101 Ointment in Patients With Plaque Psoriasis
The goal of this clinical trial is to evaluate the effectiveness of QY101 ointment in adult patients with plaque psoriasis (2-20% BSA).
Read the detailed description
Participants will be stratified and randomly assigned to trial groups two (Test group 1:0.3%; Test group 2:1.0%, 60 patients per group) or placebo group (40 patients) according to the ratio of 3:3:2 and BSA (BSA < 10% or BSA ≥ 10%) . All groups will be receive with QY101 ointment or placebo, treatment for twice daily (BID) for 12 weeks; All subjects are required to take part in visit at 2, 4, 6, 8 and 12 weeks, they were followed up for efficacy assessment, safety examination and pharmacokinetics samples collection (with week 8 as the primary efficacy endpoint), and safety follow-up was administered 28 ± 7 days after the last dose via telephone .
- Conditions
- Psoriasis
- Being tested
- QY101Placebo/QY101 ointment
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QY101Placebo/QY101 ointmentDrug
External use for BID
| Study group | Role | What they receive |
|---|---|---|
| QY101 placebo ointment | Placebo comparator | 40 subjects use QY101 placebo ointment twice daily for 12 weeks Receives: Drug: QY101Placebo/QY101 ointment |
| 0.3% QY101 ointment | Experimental | 60 subjects use QY101 placebo ointment twice daily for 12 weeks Receives: Drug: QY101Placebo/QY101 ointment |
| 1.0 % QY101 ointment | Experimental | 60 subjects use1.0 % QY101 ointment twice daily for 12 weeks Receives: Drug: QY101Placebo/QY101 ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physician Global Assessment（PGA）response
At week 8, the proportion of subjects in each trial group who responded to the Physician Global Assessment (PGA) compared to the placebo group.
The PGA response was defined as a PGA score of 0 (clear) or 1 (nearly clear) and an improvement of ≥ 2 points from baseline on the PGA scale.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2023
- Study start17 May 2023
- Primary completion29 Feb 2024 (estimated)
- Study completion30 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- E-nitiate Biopharmaceuticals (Hangzhou) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06170840
- Sponsor's protocol ID
- QY101-Ⅱ-1
- Status last verified
- Dec 2023
- First submitted
- 6 Dec 2023
- Last updated
- 19 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2023. 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 Trial to Evaluate the Efficacy and Safety of QY101 Ointment in Patients With Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT06170840
- Acronym / sponsor ID
- QY101-Ⅱ-1
- Conditions
- Psoriasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- E-nitiate Biopharmaceuticals (Hangzhou) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 May 2023 (actual)
- Primary completion
- 29 Feb 2024 (estimated)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 14 Dec 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.
The goal of this clinical trial is to evaluate the effectiveness of QY101 ointment in adult patients with plaque psoriasis (2-20% BSA).
Detailed description
Participants will be stratified and randomly assigned to trial groups two (Test group 1:0.3%; Test group 2:1.0%, 60 patients per group) or placebo group (40 patients) according to the ratio of 3:3:2 and BSA (BSA < 10% or BSA ≥ 10%) . All groups will be receive with QY101 ointment or placebo, treatment for twice daily (BID) for 12 weeks; All subjects are required to take part in visit at 2, 4, 6, 8 and 12 weeks, they were followed up for efficacy assessment, safety examination and pharmacokinetics samples collection (with week 8 as the primary efficacy endpoint), and safety follow-up was administered 28 ± 7 days after the last dose via telephone .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| QY101 placebo ointment | Placebo comparator | Drug: QY101Placebo/QY101 ointment40 subjects use QY101 placebo ointment twice daily for 12 weeks |
| 0.3% QY101 ointment | Experimental | Drug: QY101Placebo/QY101 ointment60 subjects use QY101 placebo ointment twice daily for 12 weeks |
| 1.0 % QY101 ointment | Experimental | Drug: QY101Placebo/QY101 ointment60 subjects use1.0 % QY101 ointment twice daily for 12 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Be able to understand and comply with the test process, voluntarily participate in the test and provide informed consent;
- When signing the informed consent, age ≤ 18 years old ≤ 75 years old, gender is not limited;
- The patient meets the diagnosis of plaque psoriasis, has a history of plaque psoriasis for ≥ 6 months before randomization, and meets the following conditions:
- Fertile men and women of childbearing age must agree to use reliable contraception from the time they sign an informed consent until six months after the last dose of the investigational drug; Blood pregnancy tests for women of childbearing age must be negative during screening and at baseline.
Key exclusion criteria (21 listed)
- Other types of psoriasis were diagnosed during screening, such as gutting psoriasis, erythrodermic psoriasis, generalized pustular psoriasis, arthropathic psoriasis, drug-induced or drug-aggravated psoriasis;
- The presence of other systemic autoimmune inflammatory diseases and skin lesions (such as eczema), which may affect the evaluation of treatment outcomes;
- Subjects who are expected to receive additional local therapy, phototherapy, or other systemic therapy other than investigational medication during the trial;
- Taking drugs that can aggravate psoriasis (such as lithium, antimalarial drugs, etc.);
- Patients who have failed or are intolerant to previous treatment with Phosphodiesterase-4 (PDE4) inhibitors;
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 |
|---|---|---|
| QY101Placebo/QY101 ointmentExternal use for BID | Drug | 0.3% QY101 ointment, 1.0 % QY101 ointment, QY101 placebo ointment |
Primary outcome
Physician Global Assessment（PGA）response
Time frame: 8 weeks
At week 8, the proportion of subjects in each trial group who responded to the Physician Global Assessment (PGA) compared to the placebo group. The PGA response was defined as a PGA score of 0 (clear) or 1 (nearly clear) and an improvement of ≥ 2 points from baseline on the PGA scale.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2023.
- Individual participant dataSharing planned: Undecided
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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.
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 of Psoriasis, run by E-nitiate Biopharmaceuticals (Hangzhou) 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 6 inclusion and 21 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: status not confirmed, as of the sponsor's last update on 19 Dec 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaoyong Man, Doctor (+86 1360051 6219, manxy@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physician Global Assessment（PGA）response (time frame: 8 weeks). 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 19 Dec 2023.