Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06398652
Status:
RECRUITING
Last Update Posted:
2024-05-03
First Post:
2024-05-01
Brief Title:
Comparative Study of CMAB015 and Secukinumab for Patients With Moderate to Severe Plaque Psoriasis
Sponsor:
Taizhou Mabtech Pharmaceutical CoLtd
Organization:
Taizhou Mabtech Pharmaceutical CoLtd
Study Overview
Official Title:
Comparative Study of the Efficacy Safety and Immunogenicity of CMAB015 and Secukinumab in Adult Patients With Moderate-severe Chronic Plaque Psoriasis
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this trial is to assess whether the efficacy of CMAB015 is similar to that of Secukinumab in patients with moderate-severe chronic plaque psoriasis It will also learn about the similarity of CMAB015 and Secukinumab in terms of safety and immunogenicity in patients with moderate-severe chronic plaque psoriasis The main question it aims to answer is
In subjects with moderate to severe plate psoriasis treated with CMAB015 Is the proportion of patients achieving a 75 improvement in PASI Psoriasis area and severity index scores relative to baseline PASI 75 the same as those treated with Secukinumab
Participants will
Receive treatment with 300 mg CMAB015 or Secukinumab by subcutaneous injection at weeks 0 1 2 3 4 and 8 followed by every 4 weeks until week 48
Visit the clinic at weeks 0 1 2 3 4 and 8 followed by every 4 weeks until week 52
Be evaluated with PASI scores body surface area BSA scores and investigators global assessment IGA mod 2011 scores
In subjects with moderate to severe plate psoriasis treated with CMAB015 Is the proportion of patients achieving a 75 improvement in PASI Psoriasis area and severity index scores relative to baseline PASI 75 the same as those treated with Secukinumab
Participants will
Receive treatment with 300 mg CMAB015 or Secukinumab by subcutaneous injection at weeks 0 1 2 3 4 and 8 followed by every 4 weeks until week 48
Visit the clinic at weeks 0 1 2 3 4 and 8 followed by every 4 weeks until week 52
Be evaluated with PASI scores body surface area BSA scores and investigators global assessment IGA mod 2011 scores
Detailed Description:
This study was a multicenter randomized double-blind secukinumab controlled 11 ratio parallel grouping equivalent design The study treatment period would be 52 weeks including a 12-week induction therapy period and a 40-week maintenance therapy period The primary endpoint was the proportion of patients achieving at least a 75 improvement in PASI scores from baseline at 12 weeks with an equivalence cut-off of 15 A total of 336 adult patients with moderate-to-severe plaque psoriasis are planned to be enrolled with 168 cases in each group Eligible subjects received 300 mg CMAB015 or Secukinumab subcutaneous injection Patients who do not achieve at least a 50 improvement in PASI scores at week 12 would withdraw from the study and patients who achieve a 50 improvement continue on maintenance therapy until the last treatment at week 48
This study is a double-blind design and a central randomization system woud be used to randomize subjects The control factors for randomization are body weight 60 kg 60 kg prior treatment prior systemic therapy with no prior biologics prior systemic therapy with biologics concomitant psoriatic arthritis yes no and PK intensive sampling yes no
This study is a double-blind design and a central randomization system woud be used to randomize subjects The control factors for randomization are body weight 60 kg 60 kg prior treatment prior systemic therapy with no prior biologics prior systemic therapy with biologics concomitant psoriatic arthritis yes no and PK intensive sampling yes no
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None