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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03463187




Registration number
NCT03463187
Ethics application status
Date submitted
22/01/2018
Date registered
13/03/2018
Date last updated
4/01/2019

Titles & IDs
Public title
Multi-Dose Study of SHR-1314 in Subjects With Moderate-to-severe Plaque Psoriasis
Scientific title
A Multi-Center, Randomized, Double-blind, Placebo-controlled, Multi-Dose Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of SHR-1314 With Expanded Dose Finding in Subjects With Moderate-to-severe Plaque Psoriasis
Secondary ID [1] 0 0
SHR-1314-A201
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Moderate-to-severe Chronic Plaque Psoriasis 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - SHR-1314
Treatment: Drugs - Placebo

Experimental: 80mg SHR-1314-Part A - SHR-1314 80mg, subcutaneously

Experimental: 160mg SHR-1314-Part A - SHR-1314 160mg, subcutaneously

Experimental: 240mg SHR-1314-Part A - SHR-1314 240mg, subcutaneously

Experimental: 40mg SHR-1314 (Part B) - SHR-1314 40mg, subcutaneously

Experimental: 80mg SHR-1314 (Part B) - SHR-1314 80mg, subcutaneously

Experimental: 160mg SHR-1314 (Part B) - SHR-1314 160mg, subcutaneously

Experimental: 240mg SHR-1314 (Part B) - SHR-1314 240mg, subcutaneously

Experimental: SHR-1314 Placebo (Part B) - SHR-1314 Placebo, subcutaneously


Other interventions: SHR-1314
Administered subcutaneously

Treatment: Drugs: Placebo
Administered subcutaneously

Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Clinically Significant Events (Part A) - Clinically significant events were defined as abnormal laboratory values and/or adverse events that are related to treatment
Timepoint [1] 0 0
From baseline through 24 weeks
Primary outcome [2] 0 0
Pharmacokinetics (PK) of SHR-1314 (Part A) - Time to Reach the Maximum Concentration After Drug Administration (Tmax)
Timepoint [2] 0 0
From baseline through 24 weeks
Primary outcome [3] 0 0
Pharmacokinetics (PK) of SHR-1314 (Part A) - Observed Maximum Serum Concentration Following Drug Administration (Cmax)
Timepoint [3] 0 0
From baseline through 24 weeks
Primary outcome [4] 0 0
Percentage of Participants With Anti-SHR-1314 Antibodies (Part A) - Percentage of participants with treatment-emergent positive anti-SHR-1314 antibodies was summarized by treatment group. Percentage was calculated based on the number of evaluable participants and was calculated by number of participants with treatment-emergent positive anti-SHR-1314 antibodies / number of evaluable participants * 100%.
Timepoint [4] 0 0
From baseline through 24 weeks
Primary outcome [5] 0 0
Percentage of subjects who achieve Psoriasis Area Severity Index (PASI) score 75 (Part B) - Percentage of subjects who achieve at least 75% improvement in the PASI (PASI 75)
Timepoint [5] 0 0
From baseline through 12 weeks
Secondary outcome [1] 0 0
Psoriasis Area Severity Index (PASI) score - PASI combines the extent of body surface involvement in 4 anatomical regions(head,trunk,arms,and legs).For each region the percent area of skin involved was estimated from 0(0%) to 6(90%-100%) and severity was estimated by clinical signs of erythema,induration and scaling with a scores range from 0(none) to 4(very severe).Each area is scored by itself and the scores were then combined for the final PASI. Final PASI calculated as:sum of severity parameters for each region*area score*weighing factor (head[0.1],upper limbs[0.2],trunk[0.3],lower limbs [0.4]).Overall scores range from 0(no psoriasis) to 72(most severe disease). Percent change from baseline in PASI score over time will be evaluated.
Timepoint [1] 0 0
From baseline through 24 weeks (Part A) or 36 weeks (Part B)
Secondary outcome [2] 0 0
Physician's Global Assessment (PGA) of 0 or 1 achievement - The PGA of psoriasis is scored on a 6-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 6-point severity scale (0 [clear] to 5 [severe]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; 4=moderate to severe; 5 = severe). Proportion of subjects achieving PGA response of 0 or 1 over time will be evaluated. PGA response of 0 or 1 is defined as a PGA score of 0 (clear) or 1 (almost clear) and an improvement of at least 2 points on the PGA scale from baseline.
Timepoint [2] 0 0
From baseline through 24 weeks (Part A) or 36 weeks (Part B)
Secondary outcome [3] 0 0
Change of dermatology life quality index (DLQI) score - Change from baseline in DLQI over time. This DLQI is a 10-question patient administered questionnaire that covers six quality of life domains including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment, with total scores ranging from 0-30 (less to more impairment)
Timepoint [3] 0 0
From baseline up to 12 weeks (Part A) or 36 weeks (Part B)
Secondary outcome [4] 0 0
Change from baseline in Body Surface Area (BSA) - Change from baseline in the BSA affected by psoriasis over time.
Timepoint [4] 0 0
From baseline through 12 weeks (Part A) or (Part B)

Eligibility
Key inclusion criteria
Major

1. Provide written informed consent before any study assessment is performed.

2. Male or female at least 18 years of age at screening.

3. At the time of randomization, moderate to severe plaque psoriasis, defined by:

- PASI score of 12 or greater and

- PGA score of 3 or greater and

- BSA affected by plaque-type psoriasis of 10% or greater.

4. Subject is a candidate for systemic psoriasis therapy and/or phototherapy and/or chemo
phototherapy.

Major
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic, and
guttate psoriasis) at screening.

2. Drug-induced psoriasis (i.e. new onset or current exacerbation from beta-blockers,
calcium channel inhibitors or lithium) at randomization.

3. Active systemic infections (other than common cold) during the two weeks before
randomization (e.g., hepatitis), or serious infections requiring hospitalization
and/or intravenous injection of antibiotic treatment within eight weeks from
randomization.

4. Presence of other skin conditions (e.g. skin infections, seborrheic dermatitis) that
in the judgement of the Investigator could interfere with assessment of psoriasis.

5. History of inflammatory bowel disease or have other ongoing active autoimmune
diseases.

6. At screening, history or symptoms of malignancy of any organ system, treated or
untreated, within the past 5 years, regardless of whether there is evidence of local
recurrence or metastases.

7. History of depression and/or suicidal ideation or behavior which in the opinion of the
Investigator, makes the subject unsuitable for clinical study participation.

8. Any severe, progressive or uncontrolled medical condition at randomization that in the
judgement of the Investigator prevents the subject from participating in the study.

9. Have a known allergy or hypersensitivity to any biologic therapy at screening that
would pose an unacceptable risk to the subject if participating in this study.

10. Concurrent or recent use of psoriasis treatments/ medications.

11. Are currently enrolled in, or discontinued from a clinical trial involving an
Investigational product (IP) within the last 4 weeks or at least 5 half-lives of the
last dosing prior to randomization, whichever is longer; or concurrently enrolled (at
randomization) in any other trials.

12. Have had a live attenuated vaccination within 12 weeks before randomization, or intend
to have a live attenuated vaccination during the course of the study, or have
participated in a vaccine clinical trial within 12 weeks prior to randomization.

13. Have evidence of positive test for hepatitis B, hepatitis C antibody, or human
immunodeficiency virus (HIV) antibodies.

A positive test for hepatitis B is defined as 1) positive for hepatitis B surface
antigen [HBsAg], or 2) positive for anti-hepatitis B core antibody [HBcAb+] but
negative for hepatitis B surface antibody [HBsAb-].

14. History or evidence of active or latent tuberculosis at screening.

15. Have laboratory test values that are considered clinically significant at screening
that, in the opinion of the Investigator, pose an unacceptable risk to the subject if
participating in the study or of interfering with the interpretation of data.

16. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a
female after conception and until the termination of gestation, confirmed by a
positive human chorionic gonadotropin laboratory test at screening or Day 0.

17. Females of child bearing potential (defined as all females physiologically capable of
becoming pregnant) and males who are unwilling or unable to use highly effective
contraception during the study and 20 weeks after the last administration of
investigational product (anticipated 5 half-lives).

18. History of alcohol or illicit drug abuse within the year prior to screening.

19. Are unwilling or unable to maintain their normal pattern of alcohol, caffeine,
smoking, and exercise from the start to the end of the study.

20. Have any other condition that precludes the subject from following and completing the
protocol, in the opinion of the Investigator.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1/Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
St George Dermatology and Skin Cancer Centre - Dermatology - Kogarah
Recruitment hospital [2] 0 0
Westmead Hospital - Westmead
Recruitment hospital [3] 0 0
Veracity Clinical Research Pty Ltd - Woolloongabba
Recruitment hospital [4] 0 0
Sinclair Dermatology - Dermatology - East Melbourne
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [4] 0 0
3002 - East Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Rhode Island
Country [6] 0 0
United States of America
State/province [6] 0 0
Texas
Country [7] 0 0
China
State/province [7] 0 0
Shanghai

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Jiangsu HengRui Medicine Co., Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a multi-regional, randomized, double-blind, placebo-controlled, clinical trial to
evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of SHR-1314 in adults
with moderate-to-severe plaque psoriasis.
Trial website
https://clinicaltrials.gov/show/NCT03463187
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jianwen Chen, MD. Ph.D.
Address 0 0
Jiangsu HengRui Medicine Co., Ltd.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Jianwen Chen, MD. Ph.D.
Address 0 0
Country 0 0
Phone 0 0
+0186 18036611985
Fax 0 0
Email 0 0
chenjianwen@hrglobe.cn
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03463187