A Real-world Observational Study to Compare Effectiveness of Deucravacitinib Vs Apremilast in Adults With Plaque Psoriasis

Psoriasis Clinical Trial

— RePhlect  

Official title:

A Real-world, Prospective, Observational Study of the Comparative Effectiveness of Deucravacitinib Versus Apremilast in Adults With Plaque Psoriasis - North American Region

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05744466
• Other study ID #: IM011-1105
• Status: Recruiting
• Start date: September 30, 2022
• Est. completion date: December 10, 2027

Study information

• Verified date: December 2023
• Source: Bristol-Myers Squibb
• Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com
• Phone: 855-907-3286
• Email: Clinical.Trials[@]bms.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to understand the comparative effectiveness of deucravacitinib versus apremilast in adults with plaque psoriasis.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: December 10, 2027
• Est. primary completion date: December 10, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Have been diagnosed with plaque psoriasis by a dermatologist
• Newly initiating an eligible medication for enrollment (i.e., deucravacitinib, apremilast)
• Actively enrolled in the CorEvitas Psoriasis Registry and have documented consent to allow copies of information from the registry be used for research purposes

Exclusion Criteria:

• Currently participating in an interventional clinical trial (does not include observational registry or study)

Related Conditions & MeSH terms

• Psoriasis

Locations

Country	Name	City	State
United States	Local Institution	Waltham	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in body surface area (BSA)		At baseline and every 6 months up to 60 months or treatment discontinuation
Primary	Investigator global assessment (IGA) response 0/1		Up to 60 months
Primary	Dermatology life quality index (DLQI) response 0/1		Up to 60 months
Primary	Time from date of treatment initiation to date of discontinuation		Up to 60 months
Secondary	75 percent improvement in Psoriasis area and severity index (PASI) score		At baseline and every 6 months up to 60 months or treatment discontinuation
Secondary	PASI score response = 5		At baseline to follow-up, up to 60 months
Secondary	PASI score response = 3		At baseline to follow-up, up to 60 months
Secondary	National psoriasis foundation (NPF) acceptable body surface area (BSA) response		At baseline to follow-up, up to 60 months
Secondary	NPF target BSA response		At baseline to follow-up, up to 60 months
Secondary	Change in investigator global assessment (IGA) score		Up to 60 months
Secondary	Change in dermatology life quality index (DLQI) response		At baseline to follow-up, up to 60 months
Secondary	Change in DLQI response =5		At baseline to follow-up, up to 60 months
Secondary	Change in visual analog scale (VAS): Itch response		At baseline to follow-up, up to 60 months
Secondary	Change in VAS: Skin Pain response		At baseline to follow-up, up to 60 months
Secondary	Change in VAS: Fatigue Response		At baseline to follow-up, up to 60 months

External Links

•   BMS Clinical Trial Information