The Purpose of This Research Study is to Compare the Efficacy and Safety of SCT630 and Adalimumab (HUMIRA®) in Adults With Plaque Psoriasis

Last updated: January 26, 2021
Sponsor: Sinocelltech Ltd.
Overall Status: Active - Not Recruiting

Phase

3

Condition

Skin Wounds

Rash

Scalp Disorders

Treatment

N/A

Clinical Study ID

NCT03927352
SCT630PS03
  • Ages 18-70
  • All Genders

Study Summary

The purpose of this research study is to compare the efficacy and safety of SCT630 and adalimumab (HUMIRA®) in adults with plaque psoriasis.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Men or women ≥ 18 and ≤ 70 years of age at time of screening.
  2. History of psoriasis for at least 6 months ,and stable moderate to severe plaquepsoriasis within 2 months prior to randomized.
  3. Moderate to severe psoriasis defined at screening and baseline by:Body surface area (BSA) affected by plaque psoriasis of 10% or greater, and PASI score of 12 or greater,and static physician's global assessment score of 3 or greater.
  4. Negative test for Interferon-gamma-release assay an chest X-ray at time of screening.
  5. Subject is a candidate for systemic therapy or phototherapy procedures.
  6. Female participants must have a negative pregnancy test; are not planning to becomepregnant; and must not be lactating.
  7. From the screening period to the end (Six months after the last administration),femaleparticipants must agree to employ a highly effective contraceptive measure.

Exclusion

Exclusion Criteria:

  1. Other forms of psoriasis,skin conditions(eg, eczema) or systemic autoimmune diseaseswhich affected the evaluation of treatment outcomes .
  2. Received local anti-psoriasis drugs within 2weeks prior to baseline;
  3. Received PUVA ,UVB or non-biologics within 4weeks prior to baseline,includingmethotrexate,Cyclosporine,tretinoins,traditional Chinese medicine,and so on.
  4. Received etanercept or its biosimilars within 4weeks prior to baseline.
  5. Received other anti-TNF ,IL-12/23inhibitors or IL-17inhibitors within12months prior tobaseline.
  6. Be receiving or had received any biologics ≤ five half-lives.
  7. Patients who previously used adalimumab or a biosimilar of adalimumab ineffectively orintolerantly.
  8. History of tuberculosis, active tuberculosis or latent tuberculosis infection.
  9. Suffering from active infection or history of infection :Systemic anti-infectivetherapy was performed 4 weeks before screening, severe infections with hospitalizationor intravenous anti-infective treatment within 8 weeks before screening or recurrent,chronic or other active infections which were assessed by researchers to increase therisk of subjects.
  10. Subjects were known to have malignant tumors or a history of malignant tumors (exceptfor skin squamous cell carcinoma in situ, basal cell carcinoma, cervical cancer insitu, or skin squamous cell carcinoma with no evidence of recurrence after thoroughtreatment, or five years prior to investigational product administration)
  11. Moderate to severe congestive heart failure (New York Heart Association Classes III orIV).
  12. Subjects with a significant disease other than psoriasis and/or a significantuncontrolled disease (such as, but not limited to, nervous system, renal, hepatic,endocrine, hematological, autoimmune or gastrointestinal disorders),and which wereassessed by researchers to increase the risk of subjects.
  13. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.5 times upperlimit of normal (ULN) ,Hemoglobin < 90 g/L ,Leukocyte count < 3.5×109/L,Platelets < 100×109/L ,Serum creatinine > 2.5 times upper limit of normal (ULN) at Screening.
  14. Received any live vaccines ≤4 weeks prior to investigational product administration,orpatients who are expecting to receive any live vaccines during the trial.
  15. Subjects had hypersensitivity to test drugs and their excipients, or drugs with thesame pharmacological and biological classification as test drugs, and had a history ofallergy to active substances or excipients of adalimumab or SCT630.
  16. Positive test for anti-nuclear antibody(ANA) or anti-double-stranded DNA antibody atscreening.
  17. Subjects were accompanied by active neuropathy, including but not limited to multiplesclerosis, Guillain-Barre syndrome, optic neuritis, transverse myelitis, orneurological symptoms suggesting demyelinating lesions of the central nervous system.
  18. Positive test for HIV antibodies, hepatitis B surface antigen (HBsAg), hepatitis Cvirus (HCV) antibodies ,or Treponema pallidum antibody at screening.
  19. The results of five tests for hepatitis B virus infection should be further tested forhepatitis B virus DNA, if it is greater than or equal to the upper limit of thereference value of each hospital.
  20. Women who are pregnant or nursing.

Study Design

Total Participants: 330
Study Start date:
September 05, 2019
Estimated Completion Date:
December 31, 2022

Connect with a study center

  • First Affiliated Hospital of Fourth Military Medical University

    Xi'an, Shaanxi
    China

    Site Not Available

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