A Study of QY101 Ointment in Subjects With Plaque Psoriasis

Last updated: December 13, 2023
Sponsor: E-nitiate Biopharmaceuticals (Hangzhou) Co., Ltd.
Overall Status: Active - Recruiting

Phase

2

Condition

Scalp Disorders

Warts

Rash

Treatment

QY101/Placebo ointment

QY101Placebo/QY101 ointment

Clinical Study ID

NCT06170840
QY101-Ⅱ-1
  • Ages 18-75
  • All Genders

Study Summary

The goal of this clinical trial is to evaluate the effectiveness of QY101 ointment in adult patients with plaque psoriasis (2-20% BSA).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Be able to understand and comply with the test process, voluntarily participate in thetest and provide informed consent;
  2. When signing the informed consent, age ≤ 18 years old ≤ 75 years old, gender is notlimited;
  3. The patient meets the diagnosis of plaque psoriasis, has a history of plaque psoriasisfor ≥ 6 months before randomization, and meets the following conditions:
  4. At baseline, plaque psoriasis covered 2% to 20% of BSA (including both ends) (scalp, palms, and soles were not counted as BSA);
  5. Physician overall assessment (PGA) ≥ 2 at baseline;
  6. Fertile men and women of childbearing age must agree to use reliable contraceptionfrom the time they sign an informed consent until six months after the last dose ofthe investigational drug; Blood pregnancy tests for women of childbearing age must benegative during screening and at baseline.

Exclusion

Exclusion Criteria:

  1. 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;
  2. The presence of other systemic autoimmune inflammatory diseases and skin lesions (suchas eczema), which may affect the evaluation of treatment outcomes;
  3. Subjects who are expected to receive additional local therapy, phototherapy, or othersystemic therapy other than investigational medication during the trial;
  4. Taking drugs that can aggravate psoriasis (such as lithium, antimalarial drugs, etc.);
  5. Patients who have failed or are intolerant to previous treatment withPhosphodiesterase-4 (PDE4) inhibitors;
  6. Known to be allergic to the study drug or related excipients (QY101 ointment andexcipients: albuvarin, light liquid paraffin, propylene glycol, Carbonic acid,glyceryl behenate, glyceryl monodistearate, hydroxyphenyl butyl, propyl gallate anddisodium edetate), or have a history of angioedema or allergy to topical drugs;
  7. receive contraindicated drugs, supplements, and other treatments prescribed in thistrial that may affect the course of psoriasis within the specified time period priorto initial dosing or planned for the duration of the trial (see Appendix 2:Concomitant medications during the trial);
  8. Participants who are participating in another interventional clinical trial or whoselast use of another investigational drug is less than 5 half-lives prior to the firstdosing of the investigational drug;
  9. any history of infection or recurrent infection requiring systemic antibiotictreatment within 2 weeks prior to first dosing, or serious infection requiringhospitalization or intravenous antibiotic treatment within 8 weeks prior to firstdosing (e.g., pneumonia, cellulitis, bone or joint infection, etc.); Recurrent,chronic, or other active infection at the time of initial dosing, if the investigatordetermines that participation in the study increases participants' risk;
  10. 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 thanvitamins and/or Paracetamol, within 2 weeks prior to initial administration;
  11. Participants who have received, or plan to receive, a live or attenuated vaccinewithin 4 weeks prior to initial administration;
  12. Abnormal laboratory test results during screening, including:
  13. Alanine aminotransferase (ALT), aspartate aminotransferase (AST) or basicphosphoric acid Enzyme (ALP) > 2.5 × Upper Limit of Normal (ULN);
  14. Serum creatinine > 1.5×ULN, or creatinine clearance < 50 mL/min.
  15. Hepatitis B surface antigen (HBsAg) positive or hepatitis B core antibody (HBcAb)positive, and hepatitis B virus deoxyribonucleic acid (HBV-DNA) positive; Or hepatitisC virus (HCV) antibody positive and HCV-RNA positive; Or positive for HIV, TreponemaPallidum-Antibody (TP-Ab) (Rapid Plasma Reagin, TP-AB) RPR] or Toluidine Red UnheatedSerum Test (except for negative Toluidine Red Unheated Serum Test, TRUST);
  16. 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 anginapectoris, myocardial infarction, coronary artery bypass grafting or coronary stentimplantation; There are severe arrhythmias that require medication or cardiacassistance, such as degree II type 2 or degree III atrioventricular block, long QTInterval, or long QT block. QT syndrome or Fridericia Corrected QT Interval (QTcF)abnormality (male > 470 ms female > 480 ms) corrected according to the Fridericiaformula and assessed by the investigator as unsuitable for participation in thisclinical trial; Hospitalization due to Cardiovascular (CV) events, CV disease or CVsurgery; Peripheral artery disease diagnosed by angiography with stroke (ischemic orhemorrhagic, including transient ischemic attack) should be excluded;
  17. Known malignant tumors or history of malignant tumors (excluding clinically cured skinbasal cell carcinoma, skin squamous cell carcinoma, cervical carcinoma in situ);
  18. Patients with psychoneuro-related diseases or history (such as depression, epilepsy),which affect medication compliance or the researcher's clinical judgment of suiciderisk;
  19. Pregnant or lactating women, female subjects or male subjects' partners planning tobecome pregnant (within 6 months after signing the informed consent to the lastadministration of the study drug);
  20. Other conditions deemed unsuitable for participation in this study by theinvestigator.

Study Design

Total Participants: 160
Treatment Group(s): 2
Primary Treatment: QY101/Placebo ointment
Phase: 2
Study Start date:
May 17, 2023
Estimated Completion Date:
April 30, 2024

Study 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 .

Connect with a study center

  • Shanghai Skin Disease Hospital

    Shanghai, Shanghai
    China

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.