Multi-Dose Study of SHR-1314 in Subjects With Moderate-to-severe Plaque Psoriasis

Therapuetic Areas:Dermatology / Plastic Surgery
Age Range:18 - Any
Start Date:December 15, 2017
End Date:October 30, 2019
Contact:Jianwen Chen, MD. Ph.D.
Phone:+0186 18036611985

Use our guide to learn which trials are right for you!

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

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.

This study is a multiple dose escalating design to evaluate the safety, PK, and
pharmacodynamics (PD) of multiple subcutaneous injections of SHR-1314. There are two parts in
this study. The safety, PK, and PD will be evaluated in Part A, the dose escalation part. The
efficacy and safety on different doses will be assessed in parallel-groups in Part B.

Major Inclusion Criteria:

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

Major 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

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

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.
We found this trial at
Johnston, Rhode Island 02919
Phone: 401-454-3800
Johnston, RI
Click here to add this to my saved trials
1085 N Harbor Blvd
Anaheim, California 92801
(714) 774-7777
Phone: 714-774-7777
Anaheim Clinical Trials, LLC Anaheim Clinical Trials (ACT) is a research center of excellence for...
Anaheim, CA
Click here to add this to my saved trials
Chicago, Illinois 60640
Phone: 773-275-3500
Chicago, IL
Click here to add this to my saved trials
Doral, Florida 33122
Phone: 305-982-8892
Doral, FL
Click here to add this to my saved trials
Hialeah, Florida 33012
Phone: 305-825-6588
Hialeah, FL
Click here to add this to my saved trials
Houston, Texas 77030
Phone: 713-528-8818
Houston, TX
Click here to add this to my saved trials
Kogarah, New South Wales
Phone: (02) 95874277
Click here to add this to my saved trials
Phoenix, Arizona 85018
Phone: 602-788-3437
Phoenix, AZ
Click here to add this to my saved trials
Webster, Texas 77598
Phone: 281-333-2228
Webster, TX
Click here to add this to my saved trials