Table of Contents
- Clinical trial overview
- Conditions being studied
- Trial phases and study design
- What the trials measure
- Who can participate
- Key trials at a glance
- Patient-friendly terms
Clinical trial overview
The available studies are testing Sonelokimab in adults with inflammatory diseases. These studies are designed to see whether the treatment can improve symptoms, reduce disease activity, and remain safe over time.[1][2]
Most of the trials are interventional studies, which means the research team gives the study treatment and then measures the results.[1]
Conditions being studied
The trials cover several conditions. These include psoriatic arthritis, hidradenitis suppurativa, palmoplantar pustulosis, and axial spondyloarthritis.[1][2][3][4]
Some studies focus on one condition only, such as hidradenitis suppurativa or palmoplantar pustulosis. Other studies include more than one condition, such as psoriatic arthritis and axial spondyloarthritis together.[5]
These conditions are described in the trial records as active, moderate to severe, or both. That means the studies are looking at people whose disease is already causing clear symptoms and burden.[1][2]
Trial phases and study design
The trial set includes both Phase 2 and Phase 3 studies.[1][2][3]
Phase 2 studies in the data are smaller and are used to explore treatment effects and imaging changes. For example, one completed Phase 2 study in palmoplantar pustulosis included 30 participants, and one imaging study in axial spondyloarthritis included 25 participants.[1][4]
Phase 3 studies are larger and compare Sonelokimab with placebo, which is a look-alike treatment with no active medicine, or with an active reference arm in one study.[2][3][6]
Several Phase 3 trials are authorised and have large enrollment numbers, including 694, 809, 1162, 400, 400, and 1560 participants.[2][3][6]
What the trials measure
The main outcomes are different depending on the disease being studied. In palmoplantar pustulosis, the key measure is the change in PPPASI score at Week 16, which tracks how severe the skin disease is and whether it improves.[1]
In psoriatic arthritis, the main outcome in two large studies is ACR50 at Week 16. This means at least 50% improvement on a standard arthritis response scale.[2][6]
In hidradenitis suppurativa, the studies measure HiSCR75 at Week 16. This is a response score used to show improvement in skin lesions.[3][7]
Some studies focus on safety and tolerability, including treatment-emergent adverse events, serious adverse events, study withdrawal because of side effects, special safety events, vital signs, ECG results, and lab tests.[3][8]
Two imaging studies measure inflammation in the body using PET-based scans. One looks at 18F-NaF SUVmax in the sacroiliac joints and spine, and another looks at 68Ga-FAPI SUVmax per lesion at Week 12.[4][5]
Who can participate
Most studies are for adults, and one psoriatic arthritis study specifically includes participants aged 18 years and over.[2][6]
Some psoriatic arthritis studies require an inadequate response to anti-TNFα, meaning the person did not improve enough on a previous biologic treatment that blocks tumor necrosis factor alpha.[2]
Another psoriatic arthritis study includes adults who are naive to biologic DMARDs, meaning they have not yet used biologic disease-modifying anti-rheumatic drugs.[6]
The hidradenitis suppurativa studies include adults with moderate to severe disease, and the palmoplantar pustulosis study includes patients with moderate-to-severe disease as well.[1][3][7]
Key trials at a glance
The table below shows the main studies in the data set and the broad purpose of each one.[1][2][3][4][5][6][7][8]
| Trial ID | Phase | Condition | Main purpose | Status |
|---|---|---|---|---|
| 2024-513305-32-00 | Phase 2 | Palmoplantar pustulosis | Measure improvement in PPPASI at Week 16 | Completed |
| 2024-516219-25-00 | Phase 3 | Psoriatic arthritis | Compare Sonelokimab with placebo and an active reference arm using ACR50 | Authorised |
| 2025-520564-17-00 | Phase 3 | Hidradenitis suppurativa | Study long-term safety, tolerability, and efficacy | Authorised |
| 2024-516213-20-00 | Phase 3 | Psoriatic arthritis | Compare Sonelokimab with placebo using ACR50 | Authorised |
| 2024-513498-36-00 | Phase 2 | Axial spondyloarthritis | Explore imaging changes on PET scan | Completed |
| 2024-511363-28-00 | Phase 3 | Hidradenitis suppurativa | Compare Sonelokimab with placebo using HiSCR75 | Authorised |
| 2024-511360-87-00 | Phase 3 | Hidradenitis suppurativa | Compare Sonelokimab with placebo using HiSCR75 | Authorised |
| 2024-514504-13-00 | Phase 2 | Psoriatic arthritis, axial spondyloarthritis | Explore imaging changes with FAPI-PET/low-dose CT | Authorised |
| 2025-522471-28-00 | Phase 3 | Psoriatic arthritis | Study long-term safety, tolerability, and efficacy | Authorised |
Patient-friendly terms
PPPASI is a score used to track how bad palmoplantar pustulosis is and whether it gets better.[1]
ACR50 is a standard arthritis measure showing at least 50% improvement in symptoms and signs of disease activity.[2][6]
HiSCR75 is a skin study response measure used in hidradenitis suppurativa trials.[3][7]
PET scan is an imaging test that can show where inflammation is active in the body.[4][5]
ECG stands for electrocardiogram, a test that records the heart’s electrical activity.[3][8]
