Effect of Tildrakizumab in Patients with Moderate-to-Severe Plaque Psoriasis
- Conditions
- Health Condition 1: L409- Psoriasis, unspecified
- Registration Number
- CTRI/2023/06/053784
- Lead Sponsor
- Sun Pharmaceutical Industries Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 115
1. Ability to understand the purpose and risks of the trial, willingness and ability to comply with the protocol and provide written informed consent in accordance with the applicable guidelines.
2. Patient must be at least 18 years of age of either gender
3. Diagnosis of plaque psoriasis
4. Psoriasis Area and Severity Index score more than or equal to 12 at screening and baseline.
5. Physicians Global Assessment of at least moderate disease at screening and baseline.
6. Has no history of untreated latent or active TB prior to Screening. Has no signs or symptoms suggestive of active TB upon medical history and or physical examination.
7. Patients with abnormal clinical laboratory tests
8. Patient must have results of a physical examination within normal limits or clinically acceptable limits to the investigator prior to the first dose of study medication.
9. Patient is unlikely to conceive, as indicated by at least one yes answer to the following questions a) Patient is a male.
b) Patient is a surgically sterilized female. c) Patient is a postmenopausal female more than or equal to 45 years of age with more than 1 year since last menses. d) Female patient of childbearing potential (not fulfilling above criteria b and c), agree to use highly effective methods of contraception to prevent pregnancy during the study (such contraception may include hormonal birth control eg combined estrogen and progestogen containing [oral, intravaginal, or transdermal] or progesterone only [oral, injectable, or implantable] hormonal contraception associated with inhibition of ovulation, intrauterine devices, intrauterine hormone releasing system OR bilateral tubal occlusion, vasectomized partner, or total sexual abstinence).
11. For a woman of childbearing potential, a negative urine pregnancy test at Screening and enrolment.
1. Presence of predominantly non plaque forms of psoriasis
2. Patient who is expected to require topical therapy, phototherapy, or systemic therapy for psoriasis during the trial.
3. Presence of any infection or history of recurrent infection or severe infection (e.g. pneumonia, cellulitis, bone or joint infections).
4. Women of childbearing potential who are pregnant, intend to become pregnant, or are lactating.
5. Patients with history of positive test results for HIV, HBsAG, or HCV.
6. Patient who is currently participating in another interventional clinical trial or has participated in an interventional clinical trial within 4 weeks prior to Screening.
7. Patient or his or her family member is among the personnel of the investigational site or Sponsor or designee staff directly involved with this trial.
8. Within 6 months prior to Screening, any significant organ dysfunction or clinically significant laboratory abnormalities that place the patient at unacceptable risk for participation in a trial of an immunomodulatory therapy in the judgment of the investigator.
9. Hospitalization due to an acute cardiovascular event, cardiovascular illness, or cardiovascular surgery within 6 months of screening.
10. Patient who has sustained, uncontrolled hypertension or uncontrolled diabetes.
11. Patient who, in the opinion of the investigator, will not be able to participate optimally in the trial.
12. Patient who, in the opinion of the investigator, has a history of alcohol or drug abuse in the previous year.
13. Patient with any previous use of tildrakizumab or other interleukin (IL) 23/T helper 17 cells (Th17) pathway inhibitors, including p40, p19 and IL-17 antagonists.
14. Patient who has received any treatment listed below within the indicated period prior to enrolment.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of patients with PASI 75 response at Week 12Timepoint: at Week 12
- Secondary Outcome Measures
Name Time Method Change and percent change from baseline in PASI score over timeTimepoint: Weeks 12, 16 and 28;Change from baseline in DLQITimepoint: at Weeks 12, 16 and 28;Proportion of patients achieving ACR 20, ACR 50, ACR 70 responseTimepoint: at Weeks 12, 16 and 28;Proportion of patients who achieve PASI scores less than 5, 3, and 1Timepoint: at Week 28;Proportion of patients with PASI 75 responseTimepoint: at Weeks 16 and 28;Proportion of patients with PASI 90 responseTimepoint: at Weeks 12, 16 and 28