L40
Conditions
Interventions
Group 1: Bimekizumab (BKZ) for active PsO (as indicated in clinical routine care)
Group 2: Non-biologic conventional systemic therapy (nbCST) for active PsO (as indicated in clinical routine care)
Sponsors
Fraunhofer ITMP
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: • Dermatologically confirmed moderate to severe PsO (plaque-type), fulfilling at least 2 out of 5 criteria of the following: o Presence of Nail Matrix Psoriasis o Early onset of PsO (onset = 30 years of age) o Positive family history of PsA o Disease duration of PsO = 20 years o No presence of PsO-involvement of palms/soles • Positive signal intensities in NIR-FOI rated as early inflammatory changes in microvascularization, equivalent to the definition of NIR-FOI+ (see above) • Age 18 - 75 years • Written informed consent obtained prior to the initiation of any protocol required procedures • Willing and able to comply to study procedures and study protocol
Exclusion criteria
Exclusion criteria: • PsA diagnosis according to CASPAR criteria • Disease duration of PsO = 25 years • Late onset type of PsO • Forms of psoriasis other than chronic plaque type psoriasis (e.g., pustular psoriasis, palmoplantar pustulosis, erythrodermic and guttate psoriasis) • Previous use of biological (systemic) treatment for PsO • nbCST for PsO within 4 weeks before BL (generally, previous nbCST for PsO is allowed; only not within 4 weeks before BL) • Hypersensitivity to ICG • Pregnancy or breast feeding • Wounds at hands at the physician's discretion • Iodine allergy • Manifest hyperthyroidism, autonomic thyroid adenomas, focal and diffuse autonomies of the thyroid gland • Renal insufficiency • Evidence of significant uncontrolled concomitant diseases or serious and/or uncontrolled diseases that are likely to interfere with the evaluation of the patient’s safety and of study outcomes • Evidence or indication of drug and/or alcohol abuse or dependence, according to the judgement of the investigator • Patient is considered to belong to a vulnerable population (e.g., placed under guardianship, imprisoned) • Participation in a blinded interventional trial so that it is unclear if the patient receives study drug or placebo
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with reduction in fluorescence optical imaging activity (FOIAS) sum score in at least one phase (Phase1, Phase2, or Phase3) or prima vista mode (PVM) in the BKZ group compared to non-biological conventional systemic therapy (nbCST) at week 16. | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of incidence and diagnosis of clinically classified psoriatic arthritis (PsA) o Incidence of clinical PsA (PsA diagnosis by physician) in the bimekizumab (BKZ) group compared to the incidence in the non-biological conventional systemic therapy (nbCST) group o Number of patients maintaining negative PsA diagnosis according to clinical examination (CE) +/- ultrasound (US) assessment (US only if indicated in clinical routine care). These patients are described as CE-. o Number, proportion and incidence of patients with a clinical PsA diagnosis (CE+) in the three FOI groups (near-infrared-fluorescence optical imaging (NIR-FOI)++, NIR-FOI+ and NIR-FOI-). o Time to onset of PsA Assessment of NIR-FOI signal (comparison only between the two treatment groups for all following endpoints under this objective) o Fluorescence optical imaging activity score (FOIAS) for phase 1 (P1), phase 2 (P2), phase 3 (P3) and prima vista mode (PVM) (each considered separately) for every single joint o FOIAS sum score for P1, P2, P3 and PVM (each considered separately) and change to baseline (BL) o Proportion of patients with a reduction of FOIAS sum score for P1, P2, P3 and PVM (each considered separately) o Correlation of the change of FOIAS sum score for P1, P2, P3 and PVM (each considered separately) and new PsA diagnosis within the 3-year follow-up. Change of FOIAS sum score is defined as difference of FOIAS sum score between time of PsA diagnosis and BL. o Number and proportion of NIR-FOI++, NIR-FOI+ and NIR-FOI- patients o Determination if NIR-FOI signal (FOIAS score) and its relationship to subclinical PsA (e.g., signal close to joints). Subclinical PsA (silent synovio-entheseal inflammation) is defined as a negative CE regarding PsA, but positive findings in FOI and/or US with distinct musculoskeletal changes. Sensitivity, specificity and predictive value of NIR-FOI o Sensitivity and specificity of NIR-FOI+ and NIR-FOI++ findings to determine clinical P | — |
Countries
Germany
Contacts
Public ContactSabrina Zierof
Fraunhofer ITMP
Outcome results
None listed