Safety, Tolerance, Efficacy and Pharmacokinetics of JS005 Multiple Dosing
- Conditions
- Moderate to Severe Psoriasis
- Registration Number
- NCT05344248
- Lead Sponsor
- Shanghai Junshi Bioscience Co., Ltd.
- Brief Summary
JS005-002 is a randomized, double-blinded, placebo-controlled phase Ib/II clinical study to evaluate the safety, tolerability, efficacy and pharmacokinetic profiles of multiple doses of JS005 (recombinant humanized anti-IL-17A monoclonal antibody) Injection in patients with moderate to severe psoriasis.
- Detailed Description
This study includes a total of two parts, the first part is a double-blinded, placebo-controlled, multi-dose escalation study to evaluate the safety, preliminary efficacy and pharmacokinetic profiles after multiple doses in patients with moderate to severe psoriasis; the second part is a randomized, double-blinded, controlled study, with proposed high-, middle- and low-dose groups and placebo group based on the clinical effective dose determined in the first part, to evaluate the efficacy and safety of multiple doses of test drug in patients with moderate to severe psoriasis.
Part I of study (phase Ib):
A total of 4 dose groups are pre-specified in Part I of this study, i.e., 60 mg, 150 mg, 300 mg and 600 mg; multiple doses will be administered subcutaneously on abdomen. A total of 40 patients are planned to be enrolled, including 6 and 2 patients receiving test drug and placebo in 60 mg and 600 mg dose groups, respectively, 9 and 3 patients receiving test drug and placebo in the other two dose groups, respectively. Each patient can receive multiple doses at only one dose level.
Part II of study (phase II):
Based on the safety data of phase Ib study and the efficacy analysis of ER modeling, 300mg and 150mg of the test drug will be selected. A multi-center, double-blind, placebo-controlled phase II study was conducted. The patients will be radomized in a 1:1:1 ratio to receive 300mg, 150mg doses of the study drug or placebo. A total of 126 patients will be enrolled in phase II study, with 42 patients in each group. 300mg, 150mg doses of the study drug or placebo will be administered abdominal subcutaneously with multiple dosing. Each patient can receive multiple doses at only one dose level.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 183
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Primary Outcome Measures
Name Time Method II: The proportion of patients with at least PASI 75 at Week 12 From week 0 to week 12 The Proportion of patients with at least 75% improvement in PASI (PASI 75) at Week 12
the numbers of adverse event(AE) 0-24 weeks Safety evaluation will be documented as numbers of adverse event(AE)
- Secondary Outcome Measures
Name Time Method Ib: PK evaluation: Cmax 0-24 weeks Maximum Plasma Concentration (Cmax)
Ib: PD evaluation: level of IL-17A 0-24 weeks Population pharmacokinetic parameters will be provided and individual pharmacokinetic reports will be provided
Ib: PASI score response criteria 0-24 weeks Mean change in PASI score from baseline at Week 12, 16 and 24.
Ib: Proportion of Patients achieving PASI 75 0-24 weeks Proportion of patients achieving PASI 75 at Week 12, 16 and 24.
II: PASI score response criteria 0-20 weeks Mean change in PASI score from baseline at Week 12, 16 and 20.
Ib: Proportion of Patients achieving PASI 90/100 0-24 weeks Proportion of patients achieving PASI 90/100 at Week 12, 16 and 24.
Ib: Proportion of patients with PGA score 0-12 weeks Proportion of patients with PGA score of 0 or 1 at Week 12
Ib: Mean change from baseline in body surface area (BSA) 0-24 weeks Mean change from baseline in body surface area (BSA) affected by psoriasis at Week 12, 16 and 24
Ib: Proportion of patients with DLQI score 0-24 weeks Proportion of patients with DLQI score of 0 or 1 at Week 12, 16 and 24
Ib: Time to ADA occurrence after drug administration 0-24 weeks Time to ADA occurrence after drug administration.
Ib: Time to Nab occurrence after drug administration. 0-24 weeks Time to Nab occurrence after drug administration.
II: Proportion of Patients achieving PASI 90 0-20 weeks Proportion of PASI 90 patients at week 12, 16, and 20
II: Proportion of patients with PGA score 0-20 weeks Proportion of patients with PGA score of 0 or 1 at Week 12, 16 and 20
II: Patients achieving PASI 75 0-20 weeks Proportion of patients achieving PASI 75 at Week 16 and 20.
II: PASI and/or with PGA score response criteria 0-20 weeks Proportion of patients meeting PASI75/90/100 and/or with PGA score of 0 or 1 at Week 12, 16 and 20
II: BSA response criteria 0-20 weeks Change in BSA from baseline at Week 12, 16 and 20
Proportion of patients with DLQI score 0-20 weeks Proportion of patients with DLQI score of 0 or 1 at Week 12, 16 and 20
II: The numbers of adverse event(AE). 0-20 weeks Safety evaluation will be documented as numbers of adverse event(AE).
II: PK evaluation: Cmax 0-20 weeks Maximum Plasma Concentration (Cmax)
II: PD evaluation: IL-17A 0-20 weeks Population pharmacokinetic parameters will be provided and individual pharmacokinetic reports will be provided
II: Time to ADA occurrence after drug administration. 0-20 weeks Time to ADA occurrence after drug administration.
Ib:PK evaluation: AUC0-inf 0-24 weeks Area under the plasma concentration versus time curve (AUC0-inf)
Ib: Percentage of patients with positive ADA after drug administration. 0-24 weeks Analysis of anti-drug antibody (ADA)
Ib: Percentage of patients with positive Nab after drug administration. 0-24 weeks Detection of neutralizing antibody (Nab)
II: PK evaluation: AUC0-inf 0-20 weeks Area under the plasma concentration versus time curve (AUC0-inf)
II: Percentage of patients with positive ADA after drug administration. 0-20 weeks Analysis of anti-drug antibody (ADA)
Trial Locations
- Locations (22)
Chinese PLA General Hospital
🇨🇳Beijing, Beijing, China
Peking University People's Hospital
🇨🇳Beijing, Beijing, China
Peking University Third Hospital
🇨🇳Beijing, Beijing, China
Beijing Tsinghua Changgung Hospita
🇨🇳Beijing, Beijing, China
The First Affiliated Hospital of Chongqing Medical University
🇨🇳Chongqing, Chongqing, China
Guangdong Provincial People's Hospital
🇨🇳Guangzhou, Guangdong, China
Dermatology Hospital of Southern Medical University
🇨🇳Guangzhou, Guangdong, China
The First Hospital of Hebei Medical University
🇨🇳Shijiazhuang, Hebei, China
Second Affiliated Hospital of Harbin Medical University
🇨🇳Haerbin, Heilongjiang, China
Dermatology Hospital, Chinese Academy of Medical Sciences
🇨🇳Nanjing, Jiangsu, China
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