Moderate to Severe PsoriasisPhase 1/2NCT05344248
Safety, Tolerance, Efficacy and Pharmacokinetics of JS005 Multiple Dosing
A Phase 1/2 study testing JS005 (recombinant humanized monoclonal antibody against IL-17A) in people with Moderate to Severe Psoriasis, run by Shanghai Junshi Bioscience Co., Ltd. at 22 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Moderate to Severe Psoriasis
- What is being tested?
- JS005 (recombinant humanized monoclonal antibody against IL-17A)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 183 participants
- Where
- 22 sitesChina
- Study dates
- 20 Jan 2021to 1 Nov 2022
- Phase
- Phase 1/2
- 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
- Male and female patients aged 18 ~ 75 years (inclusive, age limited to 18 ~ 60 years in Part I of the study);
- Body mass index (BMI) = weight (kg)/ height 2 (m2), ranging from 18~30 kg/m2 (inclusive) at screening;
- Being able to understand the content of the study and voluntary to sign the informed consent form; meanwhile, being able to complete the study as required in the protocol;
- Having been diagnosed as chronic plaque psoriasis for at least 6 months prior to screening;
- Being eligible for systemic therapy. Defined as moderate to severe chronic plaque psoriasis poorly controlled with local therapy and/or phototherapy and/or previous systemic therapy;
- At screening, moderate to severe plaque psoriasis will be defined as followings: PASI score ≥ 12, PGA score ≥ 3 (in accordance with 0 ~ 5-point scale), and body surface area (BSA) affected by plaque psoriasis ≥10%;
- No plan of pregnancy and being willing to use effective contraceptive measures for patients (including partners) from signature of informed consent to 6 months after administration of investigational product, see Appendix 7 for the specific contraceptive measures.
Who cannot join
- Prior biologic therapy (Secukinumab or Ixekizumab) that directly targets il-17 monoclonal antibody or IL-17 receptor at any time;
- Use of a therapeutic biologic within 12 weeks prior to screening, or random administration of the drug during the elimination phase (5 half-lives), whichever is longer;
- Participated in any other clinical study with investigational drug intervention within 12 weeks prior to screening, or the investigational drug was in the elimination phase (5 half-lives) at the time of randomization, whichever is longer;
- Have received live vaccine within 12 weeks prior to screening, or plan to receive live vaccine within 12 weeks after administration of the last experimental drug;
- Any infection requiring hospitalization, antiviral or antibiotic treatment within 30 days prior to screening (such as pneumonia, cellulitis, bone and joint infection, etc., and the investigator determined that the patient had low immune function and participation in this study might lead to unacceptable risks);
- Received systemic treatment of Chinese herbal medicine for psoriasis within 30 days or external medication for psoriasis within 14 days prior to screening;
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- Have received systemic treatment for psoriasis within 30 days prior to screening or were using a prohibited treatment at the time of screening.As UV exposure is one of the contraindication treatments, patients who do not wish to limit their UV exposure (e.g., sunbathing and/or using tanning devices) during the study period will be excluded;
- Non-chronic plaque psoriasis (e.g. Pustular psoriasis, erythrodermic psoriasis and intravenous psoriasis) at the time of screening;
- Drug psoriasis (new or aggravated psoriasis caused by beta blockers, calcium channel inhibitors or lithium) at the time of screening;
- The presence of other skin problems (e.g. skin infection, seborrheic dermatitis, severe allergic skin disease, etc.) that may interfere with the evaluation of psoriasis;
- A history of inflammatory bowel disease, Crohn's disease, or other persistent active autoimmune disease;
- Have a history of Tubercle bacillus (TB) infection, or chest imaging examination suggested TB infection during screening, or tuberculosis screening suggested latent tuberculosis infection;
- History of transplantation of vital organs (such as heart, lung, liver, kidney, etc.);
- A history or symptoms of malignancy in any organ system at the time of screening, whether or not it has been treated within the past 5 years, and whether or not there are signs of local recurrence or metastasis;
- Having other significant medical problems at the time of screening, including, but not limited to, uncontrolled hypertension (systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥95mmHg), congestive heart failure (New York heart association status class III or IV);
- Medical history and past history suggest other major diseases, including but not limited to gastrointestinal, renal, liver, neurological, hematological, endocrine, pulmonary, immune, psychiatric or cardiovascular and cerebrovascular diseases. The researcher considers that participation in this study would pose unacceptable risks to patients or significantly affect the study results;
- Has undergone any major surgery within 8 weeks prior to screening, or is required to undergo such surgery during the study period, which the investigator and sponsor have confirmed may pose unacceptable risks to the patients;
- Patients with serum creatinine above the upper limit of normal at screening time.Platelet \& LT during screening;100 x109/L, neutrophils \<1.5x109 /L, or hemoglobin \<85g/L, ALT or AST level increased ≥ 2 times the upper limit of normal value;
- Abnormal electrocardiogram during screening was considered clinically significant by the investigator, and participation in the study may bring unacceptable risks to the patients;
- At the time of screening, HBV DNA copy number was detected in persons who were positive for human immunodeficiency virus antibody (ANTI-HIV), hepatitis C virus antibody (anti-HCV), hepatitis B surface antigen (HBsAg) or HBcAb (upper limit of reference value of each hospital for quantitative test line);
- Known to suffer from moderate to severe allergic diseases or hypersensitivity reactions;
- Known history of allergy or hypersensitivity to study drugs, other monoclonal antibodies and therapeutic protein preparations (human serum albumin, cytokines, interleukins, etc.);
- Screening and randomization of female patients with β -human Chorionic Gonadotropin (β-HCG) positivity or breastfeeding;
- Blood loss or blood donation within the last 3 months \& GT;400mL, or patients who had received blood transfusion, or who planned to donate blood during the study;
- Any other conditions considered unsuitable for study participation by the investigator, such as patients with other potential compliance problems, inability to complete all examinations and evaluations as required by the protocol, or uncontrolled neuropsychiatric or psychological disorders, present uncontrollable risks of study participation.
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
China22 sites
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100039
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Beijing Tsinghua Changgung Hospita
Beijing, Beijing Municipality, 102218
First Hospital of Jilin University
Changchun, Jilin, 130061
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400042
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510080
Dermatology Hospital of Southern Medical University
Guangzhou, Guangdong, 516006
Second Affiliated Hospital of Harbin Medical University
Haerbin, Heilongjiang, 150086
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310006
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, 310014
Dermatology Hospital affiliated to Shandong First Medical University
Jinan, Shandong, 250022
Qilu Hospital of Shandong University
Jinan, Shandong, 250063
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330008
Dermatology Hospital, Chinese Academy of Medical Sciences
Nanjing, Jiangsu, 210042
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200025
Shanghai Skin Disease Hospital
Shanghai, Shanghai Municipality, 200050
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050030
The First Affiliated Hospital of Shanxi Medical University
Taiyuan, Shanxi, 300001
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052
Affiliated Hospital of Tianjin Academy of Traditional Chinese Medicine
Tianjin, Tianjin Municipality, 300120
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, 212001
About this study
Official title: A Randomized, Double Blinded, Multi-center, Placebo Controlled, Phase Ib/II Clinical Study to Evaluate the Safety, Tolerability, Efficacy and Pharmacokinetic Profiles of Multiple Doses of JS005 in Patients With Moderate to Severe Plaque Psoriasis
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.
Read the 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.
- Conditions
- Moderate to Severe Psoriasis
- Being tested
- JS005 (recombinant humanized monoclonal antibody against IL-17A), JS005 placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JS005 (recombinant humanized monoclonal antibody against IL-17A)Biological
Subcutaneous injection
JS005 placeboBiological
Subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| JS005 (recombinant humanized monoclonal antibody against IL-17A) | Experimental | Ib：60mg、150mg、300mg、600mg；Each patient can only receive multiple doses at one dose level.Each patient received weekly dosing (QW) at weeks 0, 1, 2, 3, and 4, and quad-weekly dosing (Q4W) beginning at week 5 through week 12。 II：Multiple subcutaneous injections of the study drug and placebo in two doses of 300mg and 150mg were performed.Each patient can only receive multiple doses at one dose level.Weekly dosing (QW) was given at 0, 1, 2, 3, and 4 weeks, and quad-weekly dosing (Q4W) was given from 5 weeks to 12 weeks. Receives: Biological: JS005 (recombinant humanized monoclonal antibody against IL-17A) |
| Placebo | Placebo comparator | Ib：60mg、150mg、300mg、600mg；Each patient can only receive multiple doses at one dose level.Each patient received weekly dosing (QW) at weeks 0, 1, 2, 3, and 4, and quad-weekly dosing (Q4W) beginning at week 5 through week 12。 II：Multiple subcutaneous injections of the study drug and placebo in two doses of 300mg and 150mg were performed.Each patient can only receive multiple doses at one dose level.Weekly dosing (QW) was given at 0, 1, 2, 3, and 4 weeks, and quad-weekly dosing (Q4W) was given from 5 weeks to 12 weeks. Receives: Biological: JS005 placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
the numbers of adverse event(AE)
Safety evaluation will be documented as numbers of adverse event(AE)
Measured: 0-24 weeks
II: The proportion of patients with at least PASI 75 at Week 12
The Proportion of patients with at least 75% improvement in PASI (PASI 75) at Week 12
Measured: From week 0 to week 12
Secondary outcomes (26)
Ib: PK evaluation: Cmax
Maximum Plasma Concentration (Cmax)
Measured: 0-24 weeks
Ib: PD evaluation: level of IL-17A
Population pharmacokinetic parameters will be provided and individual pharmacokinetic reports will be provided
Measured: 0-24 weeks
Ib: PASI score response criteria
Mean change in PASI score from baseline at Week 12, 16 and 24.
Measured: 0-24 weeks
Ib: Proportion of Patients achieving PASI 75
Proportion of patients achieving PASI 75 at Week 12, 16 and 24.
Measured: 0-24 weeks
Ib: Proportion of Patients achieving PASI 90/100
Proportion of patients achieving PASI 90/100 at Week 12, 16 and 24.
Measured: 0-24 weeks
Ib: Proportion of patients with PGA score
Proportion of patients with PGA score of 0 or 1 at Week 12
Measured: 0-12 weeks
Ib: Mean change from baseline in body surface area (BSA)
Mean change from baseline in body surface area (BSA) affected by psoriasis at Week 12, 16 and 24
Measured: 0-24 weeks
Ib: Proportion of patients with DLQI score
Proportion of patients with DLQI score of 0 or 1 at Week 12, 16 and 24
Measured: 0-24 weeks
Ib: Time to ADA occurrence after drug administration
Time to ADA occurrence after drug administration.
Measured: 0-24 weeks
Ib: Time to Nab occurrence after drug administration.
Time to Nab occurrence after drug administration.
Measured: 0-24 weeks
II: Proportion of Patients achieving PASI 90
Proportion of PASI 90 patients at week 12, 16, and 20
Measured: 0-20 weeks
II: Proportion of patients with PGA score
Proportion of patients with PGA score of 0 or 1 at Week 12, 16 and 20
Measured: 0-20 weeks
II: Patients achieving PASI 75
Proportion of patients achieving PASI 75 at Week 16 and 20.
Measured: 0-20 weeks
II: PASI score response criteria
Mean change in PASI score from baseline at Week 12, 16 and 20.
Measured: 0-20 weeks
II: PASI and/or with PGA score response criteria
Proportion of patients meeting PASI75/90/100 and/or with PGA score of 0 or 1 at Week 12, 16 and 20
Measured: 0-20 weeks
II: BSA response criteria
Change in BSA from baseline at Week 12, 16 and 20
Measured: 0-20 weeks
Proportion of patients with DLQI score
Proportion of patients with DLQI score of 0 or 1 at Week 12, 16 and 20
Measured: 0-20 weeks
II: The numbers of adverse event(AE).
Safety evaluation will be documented as numbers of adverse event(AE).
Measured: 0-20 weeks
II: PK evaluation: Cmax
Maximum Plasma Concentration (Cmax)
Measured: 0-20 weeks
II: PD evaluation: IL-17A
Population pharmacokinetic parameters will be provided and individual pharmacokinetic reports will be provided
Measured: 0-20 weeks
II: Time to ADA occurrence after drug administration.
Time to ADA occurrence after drug administration.
Measured: 0-20 weeks
Ib:PK evaluation: AUC0-inf
Area under the plasma concentration versus time curve (AUC0-inf)
Measured: 0-24 weeks
Ib: Percentage of patients with positive ADA after drug administration.
Analysis of anti-drug antibody (ADA)
Measured: 0-24 weeks
Ib: Percentage of patients with positive Nab after drug administration.
Detection of neutralizing antibody (Nab)
Measured: 0-24 weeks
II: PK evaluation: AUC0-inf
Area under the plasma concentration versus time curve (AUC0-inf)
Measured: 0-20 weeks
II: Percentage of patients with positive ADA after drug administration.
Analysis of anti-drug antibody (ADA)
Measured: 0-20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start20 Jan 2021
- Primary completion28 Oct 2022
- Study completion1 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate to Severe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Junshi Bioscience Co., Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05344248
- Sponsor's protocol ID
- JS005-002-Ib/II
- Status last verified
- Mar 2022
- First submitted
- 31 Mar 2022
- Last updated
- 8 Dec 2022
- 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 8 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blinded, Multi-center, Placebo Controlled, Phase Ib/II Clinical Study to Evaluate the Safety, Tolerability, Efficacy and Pharmacokinetic Profiles of Multiple Doses of JS005 in Patients With Moderate to Severe Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT05344248
- Acronym / sponsor ID
- JS005-002-Ib/II
- Conditions
- Moderate to Severe Psoriasis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- Shanghai Junshi Bioscience Co., Ltd.University, hospital or other
- Study start
- 20 Jan 2021 (actual)
- Primary completion
- 28 Oct 2022 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 25 Apr 2022 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| JS005 (recombinant humanized monoclonal antibody against IL-17A) | Experimental | Biological: JS005 (recombinant humanized monoclonal antibody against IL-17A)Ib：60mg、150mg、300mg、600mg；Each patient can only receive multiple doses at one dose level.Each patient received weekly dosing (QW) at weeks 0, 1, 2, 3, and 4, and quad-weekly dosing (Q4W) beginning at week 5 through week 12。 II：Multiple subcutaneous injections of the study drug and placebo in two doses of 300mg and 150mg were performed.Each patient can only receive multiple doses at one dose level.Weekly dosing (QW) was given at 0, 1, 2, 3, and 4 weeks, and quad-weekly dosing (Q4W) was given from 5 weeks to 12 weeks. |
| Placebo | Placebo comparator | Biological: JS005 placeboIb：60mg、150mg、300mg、600mg；Each patient can only receive multiple doses at one dose level.Each patient received weekly dosing (QW) at weeks 0, 1, 2, 3, and 4, and quad-weekly dosing (Q4W) beginning at week 5 through week 12。 II：Multiple subcutaneous injections of the study drug and placebo in two doses of 300mg and 150mg were performed.Each patient can only receive multiple doses at one dose level.Weekly dosing (QW) was given at 0, 1, 2, 3, and 4 weeks, and quad-weekly dosing (Q4W) was given from 5 weeks to 12 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male and female patients aged 18 ~ 75 years (inclusive, age limited to 18 ~ 60 years in Part I of the study);
- Body mass index (BMI) = weight (kg)/ height 2 (m2), ranging from 18~30 kg/m2 (inclusive) at screening;
- Being able to understand the content of the study and voluntary to sign the informed consent form; meanwhile, being able to complete the study as required in the protocol;
- Having been diagnosed as chronic plaque psoriasis for at least 6 months prior to screening;
- Being eligible for systemic therapy. Defined as moderate to severe chronic plaque psoriasis poorly controlled with local therapy and/or phototherapy and/or previous systemic therapy;
Key exclusion criteria (25 listed)
- Prior biologic therapy (Secukinumab or Ixekizumab) that directly targets il-17 monoclonal antibody or IL-17 receptor at any time;
- Use of a therapeutic biologic within 12 weeks prior to screening, or random administration of the drug during the elimination phase (5 half-lives), whichever is longer;
- Participated in any other clinical study with investigational drug intervention within 12 weeks prior to screening, or the investigational drug was in the elimination phase (5 half-lives) at the time of randomization, whichever is longer;
- Have received live vaccine within 12 weeks prior to screening, or plan to receive live vaccine within 12 weeks after administration of the last experimental drug;
- Any infection requiring hospitalization, antiviral or antibiotic treatment within 30 days prior to screening (such as pneumonia, cellulitis, bone and joint infection, etc., and the investigator determined that the patient had low immune function and participation in this study might lead to unacceptable risks);
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 |
|---|---|---|
| JS005 (recombinant humanized monoclonal antibody against IL-17A)Subcutaneous injection | Biological | JS005 (recombinant humanized monoclonal antibody against IL-17A) |
| JS005 placeboSubcutaneous injection | Biological | Placebo |
Primary outcome
the numbers of adverse event(AE)
Time frame: 0-24 weeks
Safety evaluation will be documented as numbers of adverse event(AE)
II: The proportion of patients with at least PASI 75 at Week 12
Time frame: From week 0 to week 12
The Proportion of patients with at least 75% improvement in PASI (PASI 75) at Week 12
26 secondary outcomes
Ib: PK evaluation: Cmax
Time frame: 0-24 weeks
Ib: PD evaluation: level of IL-17A
Time frame: 0-24 weeks
Ib: PASI score response criteria
Time frame: 0-24 weeks
Ib: Proportion of Patients achieving PASI 75
Time frame: 0-24 weeks
Ib: Proportion of Patients achieving PASI 90/100
Time frame: 0-24 weeks
Ib: Proportion of patients with PGA score
Time frame: 0-12 weeks
Ib: Mean change from baseline in body surface area (BSA)
Time frame: 0-24 weeks
Ib: Proportion of patients with DLQI score
Time frame: 0-24 weeks
Ib: Time to ADA occurrence after drug administration
Time frame: 0-24 weeks
Ib: Time to Nab occurrence after drug administration.
Time frame: 0-24 weeks
II: Proportion of Patients achieving PASI 90
Time frame: 0-20 weeks
II: Proportion of patients with PGA score
Time frame: 0-20 weeks
II: Patients achieving PASI 75
Time frame: 0-20 weeks
II: PASI score response criteria
Time frame: 0-20 weeks
II: PASI and/or with PGA score response criteria
Time frame: 0-20 weeks
II: BSA response criteria
Time frame: 0-20 weeks
Proportion of patients with DLQI score
Time frame: 0-20 weeks
II: The numbers of adverse event(AE).
Time frame: 0-20 weeks
II: PK evaluation: Cmax
Time frame: 0-20 weeks
II: PD evaluation: IL-17A
Time frame: 0-20 weeks
II: Time to ADA occurrence after drug administration.
Time frame: 0-20 weeks
Ib:PK evaluation: AUC0-inf
Time frame: 0-24 weeks
Ib: Percentage of patients with positive ADA after drug administration.
Time frame: 0-24 weeks
Ib: Percentage of patients with positive Nab after drug administration.
Time frame: 0-24 weeks
II: PK evaluation: AUC0-inf
Time frame: 0-20 weeks
II: Percentage of patients with positive ADA after drug administration.
Time frame: 0-20 weeks
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 8 Dec 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing JS005 (recombinant humanized monoclonal antibody against IL-17A) in people with Moderate to Severe Psoriasis, run by Shanghai Junshi Bioscience Co., Ltd. at 22 sites 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 7 inclusion and 25 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 8 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
the numbers of adverse event(AE) (time frame: 0-24 weeks). The study lists 2 primary outcomes in all. 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 8 Dec 2022.