Safety, Tolerance, Efficacy and Pharmacokinetics of JS005 Multiple Dosing

NCT05344248 | Completed Phase 1

• 1 other identifier: JS005-002-Ib/II
• Study Type: interventional
• Target: 183
• Locations: 1 country
• Sites: 22

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.

Conditions

Moderate to Severe Psoriasis

Outcome Measures

Primary Outcomes (2)

• the numbers of adverse event(AE)

  Safety evaluation will be documented as numbers of adverse event(AE)

  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

  From week 0 to week 12

Secondary Outcomes (26)

• Ib: PK evaluation: Cmax

  0-24 weeks

• Ib: PD evaluation: level of IL-17A

  0-24 weeks

• Ib: PASI score response criteria

  0-24 weeks

• Ib: Proportion of Patients achieving PASI 75

  0-24 weeks

• Ib: Proportion of Patients achieving PASI 90/100

  0-24 weeks

Study Arms (2)

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.

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.

Biological: JS005 placebo

Interventions

JS005 (recombinant humanized monoclonal antibody against IL-17A) BIOLOGICAL

Subcutaneous injection

JS005 (recombinant humanized monoclonal antibody against IL-17A)

JS005 placebo BIOLOGICAL

Subcutaneous injection

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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);

Sponsors & Collaborators

• Shanghai Junshi Bioscience Co., Ltd.: lead

Study Sites (22)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100039, China

Location

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

Beijing Tsinghua Changgung Hospita

Beijing, Beijing Municipality, 102218, China

Location

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400042, China

Location

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510080, China

Location

Dermatology Hospital of Southern Medical University

Guangzhou, Guangdong, 516006, China

Location

The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050030, China

Location

Second Affiliated Hospital of Harbin Medical University

Haerbin, Heilongjiang, 150086, China

Location

Dermatology Hospital, Chinese Academy of Medical Sciences

Nanjing, Jiangsu, 210042, China

Location

Affiliated Hospital of Jiangsu University

Zhenjiang, Jiangsu, 212001, China

Location

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330008, China

Location

First Hospital of Jilin University

Changchun, Jilin, 130061, China

Location

Dermatology Hospital affiliated to Shandong First Medical University

Jinan, Shandong, 250022, China

Location

Qilu Hospital of Shandong University

Jinan, Shandong, 250063, China

Location

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location

Shanghai Skin Disease Hospital

Shanghai, Shanghai Municipality, 200050, China

Location

The First Affiliated Hospital of Shanxi Medical University

Taiyuan, Shanxi, 300001, China

Location

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, 300052, China

Location

Affiliated Hospital of Tianjin Academy of Traditional Chinese Medicine

Tianjin, Tianjin Municipality, 300120, China

Location

The First Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310006, China

Location

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, 310014, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2022
• First Posted: April 25, 2022
• Study Start: January 20, 2021
• Primary Completion: October 28, 2022
• Study Completion: November 1, 2022
• Last Updated: December 8, 2022

Record last verified: 2022-03

Locations

CN (22)