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NCT05499416
Effect of Bimekizumab in Patients With Psoriasis Vulgaris and Active Psoriatic Arthritis Who Have an Inadequate Skin Response to Anti-IL23 Therapy
Phase 4 trial testing Bimekizumab in Psoriasis Vulgaris. Withdrawn.
1 September 2023
Quick facts
| Lead sponsor | Innovaderm Research Inc. |
|---|---|
| Phase | Phase 4 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Start date | 1 January 2023 |
| Primary completion | 1 September 2023 |
| Estimated completion | 1 April 2024 |
Drugs / interventions tested
- Bimekizumab (BIMEKIZUMAB) — full drug profile →
Conditions studied
- Psoriasis Vulgaris — all drugs for Psoriasis Vulgaris →
- Active Psoriatic Arthritis — all drugs for Active Psoriatic Arthritis →
Sponsor
Innovaderm Research Inc. — full company profile →
Who can join
18 and older, any sex, with Psoriasis Vulgaris or Active Psoriatic Arthritis. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Physician Global Assessment (PGA) x Body Surface Area (BSA)
Time frame: Week 24
The product of physician's global assessment and body surface area (PGA×BSA) is a measure of psoriasis severity (0-400), with higher scores indicating more severe disease. -
Proportion of patients achieving MDA
Time frame: Week 24
A patient will be considered to have achieved MDA when meeting 5/7 of the following criteria: tender joints count ≤ 1; swollen joints count ≤ 1; Psoriasis Area and Severity Index (PASI) ≤ 1 or body surface area (BSA) ≤ 3%; patient pain visual analog scale (VAS) ≤ 15 mm; patient's global assessment of arthritis visual analog scale (PtGA VAS) ≤ 20 mm; Health Assessment Questionnaire-Disability Index
Sponsor's own description
This is an open-label study to evaluate the effects of bimekizumab in patients with psoriasis vulgaris and who also have active psoriatic arthritis (PsA).
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05499416
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Bimekizumab
Trials testing the same drug.
- NCT07497620 — Bimzelx (Bimekizumab) For The Treatment Of Adult Onset PRP · Phase 4 · not yet recruiting
- NCT07352566 — Utilization of a Microdevice for Psoriasis and Atopic Dermatitis · Phase 4 · not yet recruiting
- NCT07219420 — A Study to Evaluate the Efficacy and Safety of Bimekizumab in Study Participants With Palmoplantar Pustulosis · Phase 3 · recruiting
- NCT06888193 — A Study to Assess the Concentration of Bimekizumab in Mature Breast Milk From Mothers Receiving Treatment With Bimzelx® · Phase 1 · recruiting
- NCT06742333 — Early Intervention in Plaque Psoriasis: is Bimekizumab Able to Delay Chronic Inflammation? · Phase 2 · recruiting
Other recruiting trials for Psoriasis Vulgaris
Currently open trials in the same condition.
- NCT07426120 — Efficacy and Safety of a Botanical Total Coumarin (TC) Cream in Treating Patients With Psoriasis Vulgaris (PLANTCOAT-III · Phase 3 · recruiting
- NCT07320872 — Correlation Between Vaspin Gene Polymorphism and Serum Vaspin Levels in Psoriasis Vulgaris · recruiting
- NCT06398106 — Proactive TDM Versus Standard Use of Biologics in Psoriasis · Phase 4 · recruiting
- NCT05185258 — Residual Disease MEMory in PSOriasis Skin During EnstiLAR® and Narrow-band Ultraviolet B Therapy: The MEMPSOLAR Study · Phase 4 · active not recruiting
- NCT04950218 — Prevalence and Risk Factors asSOciated With CArdiac comorbiDIty in psoriAsis · recruiting
Other Innovaderm Research Inc. trials
Trials by the same sponsor.
- NCT06283550 — Efficacy, Safety, and Tolerability of Abrocitinib in Subjects With Moderate to Severe Chronic Hand Eczema Refractory to · Phase 2 · completed
- NCT06261021 — Study to Evaluate the Efficacy of Ruxolitinib 1.5% Cream in Adult Subjects with Discoid Lupus Erythematosus · Phase 2 · recruiting
- NCT05835843 — Study to Assess the Reliability of PASI Scoring Using Digital-Based Images · completed
- NCT05844618 — Short-Term Efficacy of Triamcinolone Acetonide (Aristocort® C) in Subjects with Atopic Dermatitis · Phase 4 · completed
- NCT05602207 — Effects of Abrocitinib in Subjects With Atopic Dermatitis With an Unsatisfactory Response After Treatment With Dupilumab · Phase 4 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05499416 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Innovaderm Research Inc.
- Last refreshed: 13 March 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05499416.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing