Evaluating the Role of IL-17 as an Orchestrator of Peripheral-central Cross Talk in Depressive Symptoms

Launched by NHS GREATER GLASGOW AND CLYDE · Jan 15, 2025

Keywords

ClinConnect Summary

This clinical trial is focused on understanding how a specific immune response, known as IL-17, may affect depression in people who have conditions like psoriatic arthritis and psoriasis. Researchers want to see if targeting IL-17 can help improve depressive symptoms by examining how this immune response interacts with the brain. They will use advanced brain imaging techniques to look closely at changes in brain activity and connectivity while participants receive treatment.

To be eligible for this trial, participants need to be adults aged 18 to 75 with a confirmed diagnosis of psoriasis or psoriatic arthritis. They must be starting a treatment called secukinumab, bimekizumab, or ixekizumab as part of their routine care. Participants will undergo safety screenings and, if chosen, will engage in MRI scans to help assess their brain function. It’s important for potential participants to understand that they will need to provide informed consent and may be asked about their health history to ensure they can safely participate.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Adults ≥18 years \< 75years
• • Diagnosis of PsO or PsA, made by a dermatologist or rheumatologist.
• • Selected to start secukinumab/ bimekizumab/ Ixekizumab as part of their standard clinical care by their usual dermatology team for PsO or rheumatology clinical team for PsA in line with the license for secukinumab/ bimekizumab/ Ixekizumab and NICE/SMC criteria.
• • No contraindications to MRI (for example metal fragments or implantable devices not compatible with MRI. (no extra x-ray images will be obtained to check placement of metal fragments or clips insitu. Existing images may be used to check for possible contraindications)
• • Satisfactory completion of standard pre-biologic safety screening (including, but not limited to, exclusion of latent TB infection according to local protocol, chest X-ray, negative HIV screen, negative Hepatitis screen antibody, negative Hepatitis B surface antigen \[Hep B sAg\] and negative Hepatitis B anti-core antibody \[Hep B cAb\])
• • Recent (but not within 4 weeks prior baseline) use of intra-muscular or intra-articular steroid injections
• • Women of Child-Bearing Potential (WoCBP) must be willing to use effective contraception for study duration. Further information is provided in appendix 1.
• • Willing to participate and give informed consent
• Exclusion Criteria:
• • Inability to provide written informed consent
• • Severe physical impairment (e.g., blindness, deafness, paraplegia).
• • Clinically important, active infections e.g. active TB
• • History of inflammatory bowel disease
• • Pregnant or breast feeding
• • Severe claustrophobia precluding MRI
• • Contraindications to 7T MRI (metal implants in the ears, head or neck, microbladed/ tattooed eyebrows, metal fragments in the eyes)
• • Confounding neurological disease including MS, Stroke, Traumatic Brain Injury
• • Previous exposure to IL-17A, IL-17A/F, IL-17R inhibitors or IL-23 p19/p40 inhibitors in the last 6 months
• • Hypersensitivity to any of the excipients in secukinumab/ bimekizumab/ ixekizumab.
• • Any reason which, at the investigator's discretion, would make them unsuitable to take part in the study.