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

NCT03927352 | Unknown Phase 3

• 1 other identifier: SCT630PS03
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

• Percent Improvement From Baseline in Psoriasis Area and Severity Index (PASI) at Week 16

  The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis. Percent improvement from baseline was calculated as (value at baseline - value at post-baseline visit) × 100 / (value at baseline).

  Baseline and Week 16

Secondary Outcomes (11)

• Percent Improvement From Baseline in PASI at Week 4、8、12、24、32、48、50

  Baseline and week 4、8、12、24、32、48、50

• Percentage of Participants With a PASI 75 Response at Week 4、8、12、16、24、32、48、50

  Baseline and Week 4、8、12、16、24、32、48、50

• Percentage of Participants With a PASI 50 Response at Week 4、8、12、16、24、32、48、50

  Baseline and Week 4、8、12、16、24、32、48、50

• Percentage of Participants With a PASI 90 Response at Week 4、8、12、16、24、32、48、50

  Baseline and Week 4、8、12、16、24、32、48、50

• Percentage of Participants With a PASI 100 Response at Week 4、8、12、16、24、32、48、50

  Baseline and Week 4、8、12、16、24、32、48、50

Study Arms (2)

SCT630

EXPERIMENTAL

Participants received 80 mg SCT630 subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter until week 16. Participants with a PASI 50 response at week 16 continued to receive 40 mg SCT630 until week 48.

Biological: SCT630

adalimumab-EU source

ACTIVE COMPARATOR

Participants received 80 mg adalimumab subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter until week 16. At week 16 participants with a PASI 50 response were re-randomized to treatment with adalimumab or were transitioned to SCT630 until week 48

Biological: Adalimumab

Interventions

SCT630 BIOLOGICAL

Administered by subcutaneous injection

SCT630

Adalimumab BIOLOGICAL

Administered by subcutaneous injection

adalimumab-EU source

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men or women ≥ 18 and ≤ 70 years of age at time of screening.
• History of psoriasis for at least 6 months ,and stable moderate to severe plaque psoriasis within 2 months prior to randomized.
• 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.
• Negative test for Interferon-gamma-release assay an chest X-ray at time of screening.
• Subject is a candidate for systemic therapy or phototherapy procedures.
• Female participants must have a negative pregnancy test; are not planning to become pregnant; and must not be lactating.
• From the screening period to the end (Six months after the last administration),female participants must agree to employ a highly effective contraceptive measure.

You may not qualify if:

• Other forms of psoriasis,skin conditions(eg, eczema) or systemic autoimmune diseases which affected the evaluation of treatment outcomes .
• Received local anti-psoriasis drugs within 2weeks prior to baseline;
• Received PUVA ,UVB or non-biologics within 4weeks prior to baseline,including methotrexate,Cyclosporine,tretinoins,traditional Chinese medicine,and so on.
• Received etanercept or its biosimilars within 4weeks prior to baseline.
• Received other anti-TNF ,IL-12/23inhibitors or IL-17inhibitors within12months prior to baseline.
• Be receiving or had received any biologics ≤ five half-lives.
• Patients who previously used adalimumab or a biosimilar of adalimumab ineffectively or intolerantly.
• History of tuberculosis, active tuberculosis or latent tuberculosis infection.
• Suffering from active infection or history of infection :Systemic anti-infective therapy was performed 4 weeks before screening, severe infections with hospitalization or intravenous anti-infective treatment within 8 weeks before screening or recurrent, chronic or other active infections which were assessed by researchers to increase the risk of subjects.
• Subjects were known to have malignant tumors or a history of malignant tumors (except for skin squamous cell carcinoma in situ, basal cell carcinoma, cervical cancer in situ, or skin squamous cell carcinoma with no evidence of recurrence after thorough treatment, or five years prior to investigational product administration)
• Moderate to severe congestive heart failure (New York Heart Association Classes III or IV）.
• Subjects with a significant disease other than psoriasis and/or a significant uncontrolled disease (such as, but not limited to, nervous system, renal, hepatic, endocrine, hematological, autoimmune or gastrointestinal disorders)，and which were assessed by researchers to increase the risk of subjects.
• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 2.5 times upper limit 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.
• Received any live vaccines ≤4 weeks prior to investigational product administration,or patients who are expecting to receive any live vaccines during the trial.
• Subjects had hypersensitivity to test drugs and their excipients, or drugs with the same pharmacological and biological classification as test drugs, and had a history of allergy to active substances or excipients of adalimumab or SCT630.

Sponsors & Collaborators

• Sinocelltech Ltd.: lead

Study Sites (1)

First Affiliated Hospital of Fourth Military Medical University

Xi'an, Shaanxi, China

Location

MeSH Terms

Conditions

Psoriasis

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2019
• First Posted: April 25, 2019
• Study Start: September 5, 2019
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2022
• Last Updated: January 29, 2021

Record last verified: 2021-01

Locations

CN (1)