Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06333860
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-03-21
Brief Title:
A Study to Learn How Safe and Effective Risankizumab is When Compared to Deucravacitinib to Treat Participants With Moderate Plaque Psoriasis and Who Need to Try Systemic Treatment Works Throughout the Whole Body
Sponsor:
AbbVie
Organization:
AbbVie
Study Overview
Official Title:
A Phase 4 Multicenter Randomized Open-label Efficacy Assessor Blinded Study of Risankizumab Compared to Deucravacitinib for the Treatment of Adult Subjects With Moderate Plaque Psoriasis Who Are Candidates for Systemic Therapy
Status:
RECRUITING
Status Verified Date:
2024-10
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:
IMMpactful
Brief Summary:
Psoriasis is a long-term skin disease which causes red itchy scaly patches most commonly on the knees elbows scalp and torso chest back and abdomen In participants with psoriasis certain skin cells multiply much faster and the skin can develop rough patches that may be red or white with scales There are many types of psoriasis but plaque psoriasis is the most common The exact cause of psoriasis is unknown but researchers think it may be caused by the bodys immune system not working properly
This study is designed to enroll 336 participants 18 years of age and older with have been diagnosed with moderate chronic plaque psoriasis for at least 6 months prior to Baseline Day 1 and who have not previously been treated with a biologic treatment natural substance that is made by using living cells in a laboratory This is a Phase 4 randomized open-label assessor blinded active comparator study with 2 Parts Phase 4 studies test treatments that have already been approved to treat patients with a condition or disease This study is open-label which means that both participants and study doctors know which study treatment is given to participants
Participants will be administered subcutaneous SC treatment of risankizumab every 12 weeks for up to 44 weeks or provided deucravacitinib oral tablets to be taken once daily
There may be higher treatment burden for participants in this trial compared to their standard of care due to study procedures Participants will attend regular weekly monthly visits during the study at a hospital or clinic The effect of the treatment will be checked by medical assessments blood tests checking for side effects and completing questionnaires
This study is designed to enroll 336 participants 18 years of age and older with have been diagnosed with moderate chronic plaque psoriasis for at least 6 months prior to Baseline Day 1 and who have not previously been treated with a biologic treatment natural substance that is made by using living cells in a laboratory This is a Phase 4 randomized open-label assessor blinded active comparator study with 2 Parts Phase 4 studies test treatments that have already been approved to treat patients with a condition or disease This study is open-label which means that both participants and study doctors know which study treatment is given to participants
Participants will be administered subcutaneous SC treatment of risankizumab every 12 weeks for up to 44 weeks or provided deucravacitinib oral tablets to be taken once daily
There may be higher treatment burden for participants in this trial compared to their standard of care due to study procedures Participants will attend regular weekly monthly visits during the study at a hospital or clinic The effect of the treatment will be checked by medical assessments blood tests checking for side effects and completing questionnaires
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None