A Study to Evaluate Deucravacitinib in Participants With Moderate-to-Severe Plaque Psoriasis in Germany (DELPHIN)

Study Purpose

The purpose of this observational study is to describe the effectiveness of deucravacitinib treatment and quality of life in adults with moderate-to-severe plaque psoriasis in routine clinical practice in Germany over a 5-year period

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Patients with a physician-reported diagnosis of moderate-to-severe plaque psoriasis initiating deucravacitinib according to approved label in the European Union.
  • - The decision upon treatment with deucravacitinib must have been made before enrollment and independently of this non-interventional observational study.
  • - Patient is at least 18 years of age at the time of treatment decision.
  • - Patient provided written informed consent to participate in the study.

Exclusion Criteria:

  • - Any contraindications according to the approved deucravacitinib Summary of Product Characteristics.
  • - Prior treatment with deucravacitinib.
- Simultaneous participation in an interventional clinical trial for moderate-to-severe psoriasis

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06104644
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Bristol-Myers Squibb
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Bristol-Myers Squibb
Principal Investigator Affiliation Bristol-Myers Squibb
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Germany
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Plaque Psoriasis
Study Website: View Trial Website
Arms & Interventions

Arms

: Moderate-to-severe plaque psoriasis

Interventions

Drug: - Deucravacitinib

Non-interventional observational study of patients receiving treatment with commercially available deucravacitinib 6 mg once daily according to the Summary of Product Characteristics

Contact a Trial Team

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International Sites

Selters, Rhineland-Palatinate, Germany

Status

Recruiting

Address

Dermatologische Spezial- und Schwerpunktpraxis Selters

Selters, Rhineland-Palatinate,

Selters, Germany

Status

Recruiting

Address

Company for Medical Study & Service Selters

Selters, , 56242

Site Contact

Ralph von Kiedrowski, Site 0001

Clinical.Trials@bms.com

0049 2626900775

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