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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06382987
Other study ID # IM011-1124
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 22, 2024
Est. completion date December 31, 2029

Study information

Verified date April 2024
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
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

This is a prospective, observational, real-world study of adult participants in Japan with physician-reported diagnosis of plaque psoriasis treated with deucravacitinib or apremilast.


Recruitment information / eligibility

Status Recruiting
Enrollment 600
Est. completion date December 31, 2029
Est. primary completion date December 31, 2029
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Japanese adult participants aged 18 years old or older - Physician-reported diagnosis of plaque psoriasis - Newly initiating deucravacitinib or apremilast according to the label - Participants who have signed informed consent Exclusion Criteria: - Participants currently participating in or planning to participate in an interventional clinical trial - Patients enrolled in deucravacitinib post-marketing surveillance study (ClinicalTrial.gov ID: NCT05633264) - Previous treatment experience with the treatment of interest (e.g. patients who have history of apremilast will not be eligible to be enrolled in apremilast arm of the study and similar for deucravacitinib)

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Deucravacitinib
According to the product label
Apremilast
According to the product label

Locations

Country Name City State
Japan Fukuoka University Hospital Fukuoka
Japan Mebix. Inc. Minato-ku Tokyo

Sponsors (1)

Lead Sponsor Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in percent Body Surface Area (BSA) involved affected by plaque psoriasis from baseline to follow up in participants treated with deucravacitinib. 1 month, 3 months, 6 months and every 6 months up to 5 years
Primary Number of participants who achieved Physician's Global Assessment (PGA) of 0/1 from baseline to follow-up 1 month, 3 months, 6 months and every 6 months up to 5 years
Primary Number of participants who achieved Absolute Psoriasis Area and Severity Index (aPASI) of =2 from baseline to follow-up 1 month, 3 months, 6 months and every 6 months up to 5 years
Primary Number of participants who achieved Dermatology Life Quality Index (DLQI) of 0 /1 from baseline to follow-up 1 month, 3 months, 6 months and every 6 months up to 5 years
Primary Participant duration of treatment (time difference between date of treatment initiation to date of discontinuation) 1 month, 3 months, 6 months and every 6 months up to 5 years
Secondary Change in percent Body Surface Area (BSA) involved affected by plaque psoriasis from baseline to follow up in participants treated with deucravacitinib or apremilast 1 month, 3 months, 6 months and every 6 months up to 5 years
Secondary Number of participants who achieved Dermatology Life Quality Index (DLQI) of 0/1 from baseline to follow-up 1 month, 3 months, 6 months and every 6 months up to 5 years
Secondary Participant duration of treatment (time difference between date of treatment initiation to date of discontinuation) from baseline to follow-up 1 month, 3 months, 6 months and every 6 months up to 5 years
Secondary Number of participants treated with deucravacitinib with a change in Physician's Global Assessment (PGA) from baseline to follow-up 1 month, 3 months, 6 months and every 6 months up to 5 years
Secondary Number of participants treated with deucravacitinib with a change in Dermatology Life Quality Index (DLQI) from baseline to follow-up 1 month, 3 months, 6 months and every 6 months up to 5 years
Secondary Number of participants achieving a Dermatology Life Quality Index (DLQI) score of =5 from baseline to follow-up 1 month, 3 months, 6 months and every 6 months up to 5 years
Secondary Number of participants who achieve a Psoriasis Area Severity Index (PASI) response of 75 from baseline to follow-up 1 month, 3 months, 6 months and every 6 months up to 5 years
Secondary Number of participants who achieve a Psoriasis Area Severity Index (PASI) response of 90 from baseline to follow-up 1 month, 3 months, 6 months and every 6 months up to 5 years
Secondary Number of participants who achieve an absolute Psoriasis Area Severity Index (aPASI) score =5 from baseline to follow-up 1 month, 3 months, 6 months and every 6 months up to 5 years
Secondary Number of participants who achieve an absolute Psoriasis Area Severity Index (aPASI) score =3 from baseline to follow-up 1 month, 3 months, 6 months and every 6 months up to 5 years
Secondary Number of participants who achieve a National Psoriasis Foundation (NPF) Acceptable Body Surface Area response from baseline to follow-up 1 month, 3 months, 6 months and every 6 months up to 5 years
Secondary Number of participants who achieve an absolute scalp-specific Physician's Global Assessment (ss-PGA) of 0/1 from baseline to follow-up 1 month, 3 months, 6 months and every 6 months up to 5 years
Secondary Number of participants who achieve an absolute Physician's Global Assessment-Fingernail (PGA-F) of 0/1 from baseline to follow-up 1 month, 3 months, 6 months and every 6 months up to 5 years
Secondary Number of participants who achieve an absolute Palmoplantar Physician's Global Assessment (pp-PGA) of 0/1 from baseline to follow-up 1 month, 3 months, 6 months and every 6 months up to 5 years
See also
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