PsoriasisPhase 3NCT03927352
The Purpose of This Research Study is to Compare the Efficacy and Safety of SCT630 and Adalimumab (HUMIRA®) in Adults With Plaque Psoriasis
A Phase 3 study testing SCT630 and Adalimumab in people with Psoriasis, run by Sinocelltech Ltd. at 1 site in China.
Trial summary
The purpose of this research study is to compare the efficacy and safety of SCT630 and adalimumab (HUMIRA®) in adults with plaque psoriasis. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Psoriasis
- What is being tested?
- SCT630 and Adalimumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 1 siteChina
- Study dates
- 5 Sep 2019to 31 Dec 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
- Positive test for anti-nuclear antibody(ANA) or anti-double-stranded DNA antibody at screening.
- 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.
- Positive test for HIV antibodies, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies ,or Treponema pallidum antibody at screening.
- 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.
- Women who are pregnant or nursing.
Trial locations and contacts
1 site in 1 country.
China1 site
First Affiliated Hospital of Fourth Military Medical University
Xi'an, Shaanxi
About this study
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
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
- Being tested
- SCT630, Adalimumab
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCT630Biological
Administered by subcutaneous injection
AdalimumabBiological
Administered by subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Biological: Adalimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline and Week 16
Secondary outcomes (11)
Percent Improvement From Baseline in PASI at 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).
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: Baseline and Week 4、8、12、16、24、32、48、50
Percentage of Participants With a Static Physician's Global Assessment (sPGA) Response at 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).
Measured: Week 4、8、12、16、24、32、48、50
Change From Baseline in the Percentage of Body Surface Area (BSA) Involved With Psoriasis at 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.
Measured: Baseline and Week 4、8、12、16、24、32、48、50
Change From Baseline of dermatology life quality index (DLQI)at Week 4、8、12、16、24、32、48、50
Measured: Baseline and Week 4、8、12、16、24、32、48、50
Positive rate of ADA and NAb
Comparision of the positive rate of ADA and NAb between the SCT630 and EU-licensed Humira
Measured: Week1、4、16、32、48、50、52
Number of Participants With Adverse Events
Measured: Week2、4、8、12、16、24、32、40、48、52
Minimum Concentration of SCT630 and EU-licensed Humira
Measured: Week1、4、16、32、48、50
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2019
- Study start5 Sep 2019
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by Sinocelltech Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sinocelltech Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03927352
- Sponsor's protocol ID
- SCT630PS03
- Status last verified
- Jan 2021
- First submitted
- 22 Apr 2019
- Last updated
- 29 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03927352
- Acronym / sponsor ID
- SCT630PS03
- Conditions
- Psoriasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- Sinocelltech Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Sep 2019 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 25 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to compare the efficacy and safety of SCT630 and adalimumab (HUMIRA®) in adults with plaque psoriasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SCT630 | Experimental | Biological: SCT630Participants 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. |
| adalimumab-EU source | Active comparator | Biological: AdalimumabParticipants 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SCT630Administered by subcutaneous injection | Biological | SCT630 |
| AdalimumabAdministered by subcutaneous injection | Biological | adalimumab-EU source |
Primary outcome
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).
11 secondary outcomes
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
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
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
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
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
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
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
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
Positive rate of ADA and NAb
Time frame: Week1、4、16、32、48、50、52
Number of Participants With Adverse Events
Time frame: Week2、4、8、12、16、24、32、40、48、52
Minimum Concentration of SCT630 and EU-licensed Humira
Time frame: Week1、4、16、32、48、50
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SCT630 and Adalimumab in people with Psoriasis, run by Sinocelltech Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Improvement From Baseline in Psoriasis Area and Severity Index (PASI) at Week 16 (time frame: Baseline and Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2021.