Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06643260
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-09
Brief Title:
A Phase 3 Study in Moderate-to-Severe Plaque Psoriasis With Piclidenoson to Study Safety and Efficacy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 3 Randomized Double-Blind Placebo-Controlled Study of the Efficacy and Safety of Daily Piclidenoson CF101 Administered Orally in Subjects With Moderate-to-Severe Plaque Psoriasis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a double-blind placebo-controlled study in adults with a diagnosis of moderate-to-severe chronic plaque psoriasis to test the efficacy and safety of piclidenoson in this patient population
Detailed Description:
This is a multicenter randomized double-blind placebo-controlled study in adult males and females aged 18 years and above with a diagnosis of moderate-to-severe chronic plaque psoriasis
This trial will be conducted in 2 sequential Segments When the required number of subjects have completed Segment 1 enrollment will be paused to perform an interim analysis for futility If futility is not declared enrollment in Segment 2 will commence No subject will participate in both Segment 1 and Segment 2
For subjects in Segment 1 the design is as follows
At the Screening Visit Visit 1 performed within 4 weeks prior to randomization subjects who provide written informed consent will have screening procedures performed including a complete medical history medication history physical examination including height weight sitting blood pressure respiratory rate pulse rate and temperature ECG Patient Health Questionnaire-9 PHQ-9 Columbia Suicide Severity Rating Scale C-SSRS and assessment of psoriasis including Psoriasis Area and Severity Index PASI Static Physicians Global Assessment sPGA Body Surface Area BSA involved Psoriasis Symptoms and Signs Diary PSSD and Dermatology Life Quality Index DLQI and clinical laboratory tests
For subjects enrolled in Segment 2 the design is as follows
At the Screening Visit Visit 1 performed within 4 weeks prior to randomization subjects who provide written informed consent will have screening procedures performed including a complete medical history medication history physical examination including height weight sitting blood pressure respiratory rate pulse rate and temperature ECG PHQ-9 C-SSRS and assessment of psoriasis including PASI score sPGA BSA involved PSSD DLQI Psoriasis Scalp Severity Index PSSI for subjects with scalp involvement and Nail Psoriasis Severity Index NAPSI for subjects with nail involvement and clinical laboratory tests
The trial for Segment 2 subjects will be conducted in 3 Periods Period A Primary Efficacy Period Weeks 0-16 Period B Crossover Period Weeks 17-32 and Period C Randomized Withdrawal Period Weeks 33-52
For the patients included in Segment 1 of the trial only Period A Primary Efficacy Period Weeks 0-16 will be applicable
For the patients included in Segment 2 of the trial all the 3 study periods A B and C will be applicable
In Period A both Segments subjects will be randomized in a 21 ratio activeplacebo to receive oral piclidenoson 3 mg or matching placebo twice a day BID in double-blinded fashion The primary efficacy evaluation will occur at the end of Period AWeek 16 visit
In Period B Segment 2 only beginning at the Week 16 visit all subjects initially assigned to the placebo group will be switched to piclidenoson 3 mg BID
At the Week 24 visit and beyond including Period C subjects who do not achieve and maintain at least a PASI 50 response will be withdrawn from dosing
In Period C Segment 2 only subjects who were initially randomized to piclidenoson and achieve PASI 75 a 75 reduction from Baseline in PASI OR an sPGA of 0 or 1 with at least a 2-point improvement from Baseline at Week 32 will be rerandomized 11 blinded to continue piclidenoson or switch to placebo ie treatment withdrawal Subjects rerandomized to placebo at Week 32 will resume piclidenoson if at any in-clinic visit before Week 52 they lose treatment response defined as losing at least 50 of the PASI improvement absolute numerical score experienced at Week 32 compared to Baseline PASI score OR an sPGA 1 Subjects who were initially randomized to placebo in Period A and crossed over to piclidenoson in Period B will continue piclidenoson through Period C ie through Week 52
At Week 32 and every in-clinic visit thereafter subjects with less than PASI 75 response PASI 75 or an sPGA 1 regardless of initial treatment or current study drug treatment will be allowed to add topical treatment such as salicylic acid and low-potency or weak corticosteroids US Class 6 or 7 such as hydrocortisone desonide alclometasone dipropionate andor ultraviolet B phototherapy per Investigator judgment
Blinding for Period A Primary Efficacy Period will be maintained for the duration of the trial defined as all subjects Segment 1 and Segment 2 having completed all of their visits Due to the nature of the study design prospective double-blinding is impossible to maintain for Segment 2 Period B and Period C However effort shall be made to maintain a single blind subjects blinded as to treatment assignment during Period C
At the Week 52End of Study visit all subjects remaining on treatment in Segment 2 will be offered the opportunity to enroll in a companion open-label long-term safety and efficacy trial of piclidenoson 3 mg BID for up to an additional 4 years
Disease will be assessed using PASI sPGA the percentage of BSA involved DLQI and PSSD and where applicable PSSI andor NAPSI
Subjects enrolled in Segment 1 of the trial will return for efficacy and safety assessments and a new supply of study medication at Weeks 4 and 8 will be contacted remotely for safety monitoring at Weeks 2 and 12 and the final study assessments will be done at Week 16
Subjects enrolled in Segment 2 of the trial will return for efficacy and safety assessments and a new supply of study medication at Weeks 4 8 16 20 24 32 36 44 will be contacted remotely for safety monitoring at Weeks 2 12 28 40 and 48 and will then have the final study assessments at Week 52
PK assessment is applicable for the patients enrolled in Segment 2 only Dose proportionality effects of gender age renal function and body weight on the PK parameters will be assessed if data permit PK will be assessed through sparse sampling
This trial will be conducted in 2 sequential Segments When the required number of subjects have completed Segment 1 enrollment will be paused to perform an interim analysis for futility If futility is not declared enrollment in Segment 2 will commence No subject will participate in both Segment 1 and Segment 2
For subjects in Segment 1 the design is as follows
At the Screening Visit Visit 1 performed within 4 weeks prior to randomization subjects who provide written informed consent will have screening procedures performed including a complete medical history medication history physical examination including height weight sitting blood pressure respiratory rate pulse rate and temperature ECG Patient Health Questionnaire-9 PHQ-9 Columbia Suicide Severity Rating Scale C-SSRS and assessment of psoriasis including Psoriasis Area and Severity Index PASI Static Physicians Global Assessment sPGA Body Surface Area BSA involved Psoriasis Symptoms and Signs Diary PSSD and Dermatology Life Quality Index DLQI and clinical laboratory tests
For subjects enrolled in Segment 2 the design is as follows
At the Screening Visit Visit 1 performed within 4 weeks prior to randomization subjects who provide written informed consent will have screening procedures performed including a complete medical history medication history physical examination including height weight sitting blood pressure respiratory rate pulse rate and temperature ECG PHQ-9 C-SSRS and assessment of psoriasis including PASI score sPGA BSA involved PSSD DLQI Psoriasis Scalp Severity Index PSSI for subjects with scalp involvement and Nail Psoriasis Severity Index NAPSI for subjects with nail involvement and clinical laboratory tests
The trial for Segment 2 subjects will be conducted in 3 Periods Period A Primary Efficacy Period Weeks 0-16 Period B Crossover Period Weeks 17-32 and Period C Randomized Withdrawal Period Weeks 33-52
For the patients included in Segment 1 of the trial only Period A Primary Efficacy Period Weeks 0-16 will be applicable
For the patients included in Segment 2 of the trial all the 3 study periods A B and C will be applicable
In Period A both Segments subjects will be randomized in a 21 ratio activeplacebo to receive oral piclidenoson 3 mg or matching placebo twice a day BID in double-blinded fashion The primary efficacy evaluation will occur at the end of Period AWeek 16 visit
In Period B Segment 2 only beginning at the Week 16 visit all subjects initially assigned to the placebo group will be switched to piclidenoson 3 mg BID
At the Week 24 visit and beyond including Period C subjects who do not achieve and maintain at least a PASI 50 response will be withdrawn from dosing
In Period C Segment 2 only subjects who were initially randomized to piclidenoson and achieve PASI 75 a 75 reduction from Baseline in PASI OR an sPGA of 0 or 1 with at least a 2-point improvement from Baseline at Week 32 will be rerandomized 11 blinded to continue piclidenoson or switch to placebo ie treatment withdrawal Subjects rerandomized to placebo at Week 32 will resume piclidenoson if at any in-clinic visit before Week 52 they lose treatment response defined as losing at least 50 of the PASI improvement absolute numerical score experienced at Week 32 compared to Baseline PASI score OR an sPGA 1 Subjects who were initially randomized to placebo in Period A and crossed over to piclidenoson in Period B will continue piclidenoson through Period C ie through Week 52
At Week 32 and every in-clinic visit thereafter subjects with less than PASI 75 response PASI 75 or an sPGA 1 regardless of initial treatment or current study drug treatment will be allowed to add topical treatment such as salicylic acid and low-potency or weak corticosteroids US Class 6 or 7 such as hydrocortisone desonide alclometasone dipropionate andor ultraviolet B phototherapy per Investigator judgment
Blinding for Period A Primary Efficacy Period will be maintained for the duration of the trial defined as all subjects Segment 1 and Segment 2 having completed all of their visits Due to the nature of the study design prospective double-blinding is impossible to maintain for Segment 2 Period B and Period C However effort shall be made to maintain a single blind subjects blinded as to treatment assignment during Period C
At the Week 52End of Study visit all subjects remaining on treatment in Segment 2 will be offered the opportunity to enroll in a companion open-label long-term safety and efficacy trial of piclidenoson 3 mg BID for up to an additional 4 years
Disease will be assessed using PASI sPGA the percentage of BSA involved DLQI and PSSD and where applicable PSSI andor NAPSI
Subjects enrolled in Segment 1 of the trial will return for efficacy and safety assessments and a new supply of study medication at Weeks 4 and 8 will be contacted remotely for safety monitoring at Weeks 2 and 12 and the final study assessments will be done at Week 16
Subjects enrolled in Segment 2 of the trial will return for efficacy and safety assessments and a new supply of study medication at Weeks 4 8 16 20 24 32 36 44 will be contacted remotely for safety monitoring at Weeks 2 12 28 40 and 48 and will then have the final study assessments at Week 52
PK assessment is applicable for the patients enrolled in Segment 2 only Dose proportionality effects of gender age renal function and body weight on the PK parameters will be assessed if data permit PK will be assessed through sparse sampling
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None