Clinical trial · Interventional
A Dose Finding Study of AEB071 Assessing Psoriasis Area and Severity Index in Patients With Plaque Psoriasis
A Double Blind, Randomized, Placebo Controlled, Multicenter, Dose Finding Study of Oral AEB071 Assessing Psoriasis Area and Severity Index (PASI) Response and a Function of Dose and Treatment Duration (Primary Outcome) in Patients With Plaque Psoriasis
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is designed to provide efficacy and safety data of several doses of AEB071 so that the optimal dose and treatment duration can be chosen for testing in later studies in patients with plaque psoriasis (with a disease severity such that systemic treatment is justified). The treatment free Follow-up Period is designed to provide additional safety data and information on disease recurrence after the last dose of the study drug.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Moderate and Severe Plaque Psoriasis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AEB071 | Drug | Sotrastaurin Acetate | ALIAS |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- AEB071 200 mg BID
- interventionNames
- Drug: AEB071
- type
- EXPERIMENTAL
- label
- AEB071 400 mg OD
- interventionNames
- Drug: AEB071
- type
- EXPERIMENTAL
- label
- AEB071 300 mg BID
- interventionNames
- Drug: AEB071
- type
- PLACEBO_COMPARATOR
- label
- Placebo BID
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Moderate and Severe Plaque psoriasis diagnosed for at least 12 months (with or without psoriatic arthritis as comorbidity)that requires systemic therapy * Severity of disease meeting all of the following three criteria: * PASI score of 10 or greater * Total Body Surface Area (BSA) affected by plaque psoriasis of 10% or greater * Investigator's Global Assessment (IGA) score of 3 or greater Exclusion Criteria: * Hematological abnormalities * Heart rate \< 50 or \> 90 bpm when resting for 5 minutes * Family history of long QT syndrome * History of tachyarrhythmia * History of conduction abnormality i.e., PR \> 200 msec, 2nd or 3rd degree AV block, complete left or right branch bundle block, pre-excitation syndrome * Uncontrolled or unstable angina pectoris; history of myocardial infarction within the previous 12 months * Known history of congestive heart failure * History of percutaneous coronary intervention (PCI) or cardiac ablation * History of stroke or transient ischemic attack (TIA) * Implanted cardiac pacemaker or defibrillator * History of malignancy of any organ system * Current guttate, generalized erythrodermic, or pustular psoriasis * Current drug associated psoriasis Other protocol-defined inclusion/exclusion criteria may apply
References
Publications (0)
Data not yet available