About Bolder Science

Our mission is to provide healthcare professionals with unbiased clinical research information, easily.

Currently, you can access the following clinical trials being conducted worldwide:

359,057 studies
in
219 countries
Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/25/2021.
This website is for US healthcare professionals

Log In to Bolder Science

or

Don't have an account? Sign Up

Please enter your email address.

You will receive a link to create a new password via email.

Log In

Create an Account

or
(optional) ?

Welcome, !

Please complete the following 4 questions to ensure you receive the information that best suits your needs.

Clinical Trials of Interest

When I’m looking for information on clinical trials, I usually am interested in...

finding clinical trials in which to enroll my patients

Rarely Often

finding newly launched clinical trials (for all phases)

Rarely Often

updates on status changes for clinical trials

Rarely Often

pipeline molecules

Rarely Often

Drug Interventions

Enter up to 3 drug interventions you are currently interested in:

Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/25/2021.

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

Clinicaltrials.gov identifier NCT03927352

Recruitment Status Not yet recruiting

First Posted April 25, 2019

Last update posted April 25, 2019

Study Description

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.

  • Condition or Disease:Psoriasis
  • Intervention/Treatment: Biological: SCT630
    Biological: Adalimumab
  • Phase: Phase 3
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 330 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Double (Participant, Investigator)
  • Primary Purpose: Treatment
  • Official Title: A Phase 3, Randomized, Double-blind Study Evaluating the Efficacy and Safety of SCT630 Compared With Adalimumab in Subjects With Moderate to Severe Plaque Psoriasis
  • Estimated Study Start Date: June 2019
  • Estimated Primary Completion Date: December 2021
  • Estimated Study Completion Date: December 2022
Arms and interventions
Arm Intervention/treatment
Experimental: SCT630
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
Administered by subcutaneous injection
Active Comparator: adalimumab-EU source
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
Administered by subcutaneous injection
Outcome Measures
  • Primary Outcome Measures: 1. Percent Improvement From Baseline in Psoriasis Area and Severity Index (PASI) at Week 16 [ Time Frame: Baseline and 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).
  • Secondary Outcome Measures: 1. Minimum Concentration of SCT630 and EU-licensed Humira [ Time Frame: Week1、4、16、32、48、50 ]
  • 2. Percent Improvement From Baseline in PASI at Week 4、8、12、24、32、48、50 [ Time Frame: Baseline and week 4、8、12、24、32、48、50 ]
    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 is calculated as (value at baseline - value at post-baseline visit) × 100 / (value at baseline).
  • 3. Percentage of Participants With a PASI 75 Response at Week 4、8、12、16、24、32、48、50 [ Time Frame: Baseline and Week 4、8、12、16、24、32、48、50 ]
    A PASI 75 response is a 75% or greater improvement (reduction) from baseline in PASI score. 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.
  • 4. Percentage of Participants With a PASI 50 Response at Week 4、8、12、16、24、32、48、50 [ Time Frame: Baseline and Week 4、8、12、16、24、32、48、50 ]
    A PASI 50 response is a 50% or greater improvement (reduction) from baseline in PASI score. 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.
  • 5. Percentage of Participants With a PASI 90 Response at Week 4、8、12、16、24、32、48、50 [ Time Frame: Baseline and Week 4、8、12、16、24、32、48、50 ]
    A PASI 90 response is a 90% or greater improvement (reduction) from baseline in PASI score. 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.
  • 6. Percentage of Participants With a PASI 100 Response at Week 4、8、12、16、24、32、48、50 [ Time Frame: Baseline and Week 4、8、12、16、24、32、48、50 ]
    A PASI 100 response is a 100% or greater improvement (reduction) from baseline in PASI score. 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.
  • 7. Percentage of Participants With a Static Physician's Global Assessment (sPGA) Response at Week 4、8、12、16、24、32、48、50 [ Time Frame: Week 4、8、12、16、24、32、48、50 ]
    The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). A sPGA response is defined as a sPGA value of clear (score 0) or almost clear (score 1).
  • 8. Change From Baseline in the Percentage of Body Surface Area (BSA) Involved With Psoriasis at Week 4、8、12、16、24、32、48、50 [ Time Frame: Baseline and Week 4、8、12、16、24、32、48、50 ]
    A measurement of psoriasis involvement, given as the physician's assessment of the percentage of the participant's total body surface area (BSA) involved with psoriasis. The percent of BSA affected was estimated by assuming that the subject's palm, excluding the fingers and thumb, represented roughly 1% of the body's surface. Change from baseline is calculated as (value at post-baseline visit - value at baseline). A decrease from baseline (negative value) indicates improvement.
  • 9. Change From Baseline of dermatology life quality index (DLQI)at Week 4、8、12、16、24、32、48、50 [ Time Frame: Baseline and Week 4、8、12、16、24、32、48、50 ]
  • 10. Positive rate of ADA and NAb [ Time Frame: Week1、4、16、32、48、50、52 ]
    Comparision of the positive rate of ADA and NAb between the SCT630 and EU-licensed Humira
  • 11. Number of Participants With Adverse Events [ Time Frame: Week2、4、8、12、16、24、32、40、48、52 ]
Eligibility Criteria
  • Ages Eligible for Study: 18 to 70 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

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 plaque
psoriasis 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 become
pregnant; and must not be lactating.

7. From the screening period to the end (Six months after the last administration),female
participants must agree to employ a highly effective contraceptive measure.

Exclusion Criteria:

1. Other forms of psoriasis,skin conditions(eg, eczema) or systemic autoimmune diseases
which 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,including
methotrexate,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 to
baseline.

6. Be receiving or had received any biologics ≤ five half-lives.

7. Patients who previously used adalimumab or a biosimilar of adalimumab ineffectively or
intolerantly.

8. History of tuberculosis, active tuberculosis or latent tuberculosis infection.

9. 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.

10. 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)

11. Moderate to severe congestive heart failure (New York Heart Association Classes III or
IV).

12. 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.

13. 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 2.5 times upper limit of normal (ULN) at Screening.

14. Received any live vaccines ≤4 weeks prior to investigational product administration,or
patients who are expecting to receive any live vaccines during the trial.

15. 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.

16. Positive test for anti-nuclear antibody(ANA) or anti-double-stranded DNA antibody at
screening.

17. Subjects were accompanied by active neuropathy, including but not limited to multiple
sclerosis, Guillain-Barre syndrome, optic neuritis, transverse myelitis, or
neurological symptoms suggesting demyelinating lesions of the central nervous system.

18. Positive test for HIV antibodies, hepatitis B surface antigen (HBsAg), hepatitis C
virus (HCV) antibodies ,or Treponema pallidum antibody at screening.

19. The results of five tests for hepatitis B virus infection should be further tested for
hepatitis B virus DNA, if it is greater than or equal to the upper limit of the
reference value of each hospital.

20. Women who are pregnant or nursing.

Contacts and Locations
Contacts

Contact: Guo Ming +86-10-58628288-9138 ming_guo@sinocelltech.com

Locations
Sponsors and Collaborators

Sinocelltech Ltd.

More Information
  • Responsible Party: Sinocelltech Ltd.
  • ClinicalTrials.gov Identifier: NCT03927352 History of Changes
  • Other Study ID Numbers: SCT630PS03
  • First Posted: April 25, 2019 Key Record Dates
  • Last Update Posted: April 25, 2019
  • Last Verified: April 2019
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Psoriasis