Plaque PsoriasisDELPHINNCT06104644
A Study to Evaluate Deucravacitinib in Participants With Moderate-to-Severe Plaque Psoriasis in Germany
An observational study of Plaque Psoriasis, run by Bristol-Myers Squibb at 2 sites in Germany.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- Deucravacitinib
- How many people
- 550 participants
- Where
- 2 sitesGermany
- Study dates
- 13 Apr 2023to 31 May 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with moderate-to-severe plaque psoriasis in Germany
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
Germany2 sites
Dermatologische Spezial- und Schwerpunktpraxis Selters
Selters, Rhineland-Palatinate
Local Institution - 0001
Selters, 56242
About this study
Official title: Deucravacitinib in Routine Clinical Practice: A 5-year, Multicenter, Prospective, Non-Interventional Cohort Study to Evaluate Effectiveness and Quality of Life in Patients With Moderate-to-Severe Plaque Psoriasis in Germany (DELPHIN)
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
- Conditions
- Plaque Psoriasis
- Being tested
- Deucravacitinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DeucravacitinibDrug
Non-interventional observational study of patients receiving treatment with commercially available deucravacitinib 6 mg once daily according to the Summary of Product Characteristics
| Study group | Role | What they receive |
|---|---|---|
| Moderate-to-severe plaque psoriasis | Not described Receives: Drug: Deucravacitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients achieving an absolute Psoriasis Area Severity Index (aPASI) score ≤ 3 at Week 24 or nearest visit
Measured: Approximately 24 weeks after treatment initiation (data to be collected at visit nearest to this timepoint)
Secondary outcomes (15)
Effectiveness of deucravacitinib treatment measured by the number of participants who achieve an absolute Psoriasis Area Severity Index (aPASI) score ≤ 3 and ≤ 6
Measured: 5 years
Effectiveness of deucravacitinib treatment measured by the number of participants who achieve Psoriasis Area Severity Index (PASI) 75/90/100
Measured: 5 years
Effectiveness of deucravacitinib treatment measured by the number of participants who achieved static Physician's Global Assessment (sPGA) 0/1 and change in sPGA over time
Measured: 5 years
Effectiveness of deucravacitinib treatment measured by body surface area (BSA) affected by psoriasis and changes in BSA from baseline and over time
Measured: 5 years
Effectiveness of deucravacitinib treatment in sensitive body areas measured by Physician's Global Assessment (PGA) for the genital area
Measured: 5 years
Effectiveness of deucravacitinib treatment in sensitive body areas measured by Physician's Global Assessment (PGA) for the intertriginous areas
Including but not limited to axilla, popliteal fossa, inguinal, genital, submammary, anal region
Measured: 5 years
Effectiveness of deucravacitinib treatment in sensitive body areas measured by palmoplantar psoriasis Physician's Global Assessment (pp-PGA) for the palmoplantar area
Measured: 5 years
Effectiveness of deucravacitinib treatment in sensitive body areas measured by target Nail Psoriasis Severity Index (NAPSI) for the nails
Measured: 5 years
Effectiveness of deucravacitinib treatment in sensitive body areas measured by scalp-specific Physician's Global Assessment (ss-PGA) for the scalp
Measured: 5 years
Treatment modalities and patient's satisfaction with deucravacitinib therapy measured by the Treatment Satisfaction Questionnaire for Medication (TSQM)-9
Measured: 5 years
Treatment modalities and patient's satisfaction with deucravacitinib therapy measured by the persistence of deucravacitinib therapy
Time from therapy initiation until discontinuation visualized using Kaplan-Meier methods
Measured: 5 years
Treatment modalities and patient's satisfaction with deucravacitinib therapy measured by reasons for therapy discontinuation
Discontinuation of deucravacitinib defined as a treatment interruption of >90 days with or without resumption of deucravacitinib treatment, with or without start of a follow-up therapy
Measured: 5 years
Patient-reported outcomes measured by the Dermatology Life Quality Index (DLQI)
Measured: 5 years
Patient-reported outcomes evaluating pruritus measured by the Itch Numeric Rating Scale (NRS)
Measured: 5 years
Patient-reported outcomes measured by the Patient Benefit Index standard version (PBI-S)
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2023
- Study start13 Apr 2023
- Primary completion18 Aug 2025
- Study completion31 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plaque PsoriasisStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 550 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06104644
- Sponsor's protocol ID
- IM011-250
- Acronym
- DELPHIN
- Status last verified
- Nov 2025
- First submitted
- 6 Oct 2023
- Last updated
- 4 Dec 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deucravacitinib in Routine Clinical Practice: A 5-year, Multicenter, Prospective, Non-Interventional Cohort Study to Evaluate Effectiveness and Quality of Life in Patients With Moderate-to-Severe Plaque Psoriasis in Germany (DELPHIN)
- ClinicalTrials.gov ID
- NCT06104644
- Acronym / sponsor ID
- DELPHIN / IM011-250
- Conditions
- Plaque Psoriasis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 550 participants (estimated)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 13 Apr 2023 (actual)
- Primary completion
- 18 Aug 2025 (actual)
- Study completion
- 31 May 2030 (estimated)
- First posted
- 27 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Moderate-to-severe plaque psoriasis | – | Drug: Deucravacitinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with moderate-to-severe plaque psoriasis in Germany
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DeucravacitinibNon-interventional observational study of patients receiving treatment with commercially available deucravacitinib 6 mg once daily according to the Summary of Product Characteristics | Drug | Moderate-to-severe plaque psoriasis |
Primary outcome
Proportion of patients achieving an absolute Psoriasis Area Severity Index (aPASI) score ≤ 3 at Week 24 or nearest visit
Time frame: Approximately 24 weeks after treatment initiation (data to be collected at visit nearest to this timepoint)
15 secondary outcomes
Effectiveness of deucravacitinib treatment measured by the number of participants who achieve an absolute Psoriasis Area Severity Index (aPASI) score ≤ 3 and ≤ 6
Time frame: 5 years
Effectiveness of deucravacitinib treatment measured by the number of participants who achieve Psoriasis Area Severity Index (PASI) 75/90/100
Time frame: 5 years
Effectiveness of deucravacitinib treatment measured by the number of participants who achieved static Physician's Global Assessment (sPGA) 0/1 and change in sPGA over time
Time frame: 5 years
Effectiveness of deucravacitinib treatment measured by body surface area (BSA) affected by psoriasis and changes in BSA from baseline and over time
Time frame: 5 years
Effectiveness of deucravacitinib treatment in sensitive body areas measured by Physician's Global Assessment (PGA) for the genital area
Time frame: 5 years
Effectiveness of deucravacitinib treatment in sensitive body areas measured by Physician's Global Assessment (PGA) for the intertriginous areas
Time frame: 5 years
Effectiveness of deucravacitinib treatment in sensitive body areas measured by palmoplantar psoriasis Physician's Global Assessment (pp-PGA) for the palmoplantar area
Time frame: 5 years
Effectiveness of deucravacitinib treatment in sensitive body areas measured by target Nail Psoriasis Severity Index (NAPSI) for the nails
Time frame: 5 years
Effectiveness of deucravacitinib treatment in sensitive body areas measured by scalp-specific Physician's Global Assessment (ss-PGA) for the scalp
Time frame: 5 years
Treatment modalities and patient's satisfaction with deucravacitinib therapy measured by the Treatment Satisfaction Questionnaire for Medication (TSQM)-9
Time frame: 5 years
Treatment modalities and patient's satisfaction with deucravacitinib therapy measured by the persistence of deucravacitinib therapy
Time frame: 5 years
Treatment modalities and patient's satisfaction with deucravacitinib therapy measured by reasons for therapy discontinuation
Time frame: 5 years
Patient-reported outcomes measured by the Dermatology Life Quality Index (DLQI)
Time frame: 5 years
Patient-reported outcomes evaluating pruritus measured by the Itch Numeric Rating Scale (NRS)
Time frame: 5 years
Patient-reported outcomes measured by the Patient Benefit Index standard version (PBI-S)
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- BMS Clinical Trial InformationLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Plaque Psoriasis, run by Bristol-Myers Squibb at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients achieving an absolute Psoriasis Area Severity Index (aPASI) score ≤ 3 at Week 24 or nearest visit (time frame: Approximately 24 weeks after treatment initiation (data to be collected at visit nearest to this timepoint)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.