Evaluating the role of IL-17 as an orchestrator of peripheral-central cross talk in depressive symptoms
| ISRCTN | ISRCTN34548434 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN34548434 |
| ClinicalTrials.gov (NCT) | NCT06786936 |
| Integrated Research Application System (IRAS) | 345892 |
| NHS Sponsor Protocol Number | GN22MH376 |
| Sponsor | NHS Greater Glasgow and Clyde |
| Funder | Medical Research Council |
- Submission date
- 02/04/2026
- Registration date
- 14/04/2026
- Last edited
- 09/04/2026
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Skin and Connective Tissue Diseases
Plain English summary of protocol
Background and study aims
People with psoriatic disease often experience inflammation in the body, and some also develop symptoms of depression. This study aims to understand whether a type of medicine that blocks a protein called IL‑17 can reduce inflammation in the brain and whether this affects depressive symptoms. The study will use advanced brain scans to measure chemicals linked to mood, such as glutamate, and will look at how different parts of the brain communicate with each other.
Who can participate?
Adults aged 18 years to less than 75 years who have psoriasis or psoriatic arthritis and who have already been selected by their usual clinical team to start an IL‑17‑blocking medicine (secukinumab, bimekizumab, or ixekizumab) may be able to take part. Participants must meet standard safety checks for starting biologic treatments and be able to have an MRI scan.
What does the study involve?
Participants will be randomly allocated to receive either the IL‑17‑blocking medicine straight away or a placebo for a short period. This waiting time is similar to current NHS waiting periods before starting biologic treatment. All participants will then receive the IL‑17‑blocking medicine as part of their normal care. The study will include brain scans such as MRI, MRS and EEG to measure brain chemicals and brain activity, along with questionnaires about mood and health.
What are the possible benefits and risks of participating?
Participants may not experience direct personal benefit, but the information gained may help improve understanding and future treatment of depression linked to inflammatory disease. Risks are expected to be low and similar to routine care, but may include discomfort during MRI scanning, possible side effects from the medicine, and the small chance that placebo may delay the start of active treatment for a short time. All medicines used later in the study are already routinely prescribed for psoriatic disease.
Where is the study run from?
The study is being run from the Imaging Centre of Excellence at the Queen Elizabeth University Hospital in Glasgow, Scotland.
When is the study starting and how long is it expected to run for?
June 2025 to October 2027.
Who is funding the study?
The study is funded by the Medical Research Council, a UK government organisation that supports medical research.
Who is the main contact?
The main scientific contact is Professor Jonathan Cavanagh at the University of Glasgow. A public contact is also available: Maxine Arnott, School of Immunology and Infection, University of Glasgow.
Contact information
Principal investigator, Scientific
School of Immunology and Infection
Sir Graeme Davies Building
120 University Place
Glasgow
Glasgow
G12 8TA
United Kingdom
 ORCID ID |
0000-0003-0640-8050 |
|---|---|
| Phone | +44 141 330 7769 |
| Jonathan.cavanagh@glasgow.ac.uk |
Public
School of Immunology and Infection
Sir Graeme Davies Building
120 University Place
Glasgow
G12 8TA
United Kingdom
| Phone | +44 7890059695 |
|---|---|
| Maxine.Arnott@glasgow.ac.uk |
Study information
| Primary study design | Observational |
|---|---|
| Observational study design | Other clinical trial to study a novel intervention or randomised clinical trial to compare interventions in clinical practice. |
| Scientific title | Impact of IL‑17 blockade on nucleus accumbens glutamate in psoriatic disease: a randomised placebo controlled waiting list study using 7T MRS |
| Study acronym | ELATE |
| Study objectives | To determine: 1. The effects of IL‑17 antagonism on 7T magnetic resonance spectroscopy glutamate concentration in the NAcc 2. The effects of IL‑17 antagonism on the strength of the EEG‑informed fMRI coupling between the thalamic and NAcc learning systems and its relationship with depressive symptoms 3. The relationship between glutamate concentration and depressive symptoms after IL‑17 antagonism 4. The ability of EEG‑informed fMRI thalamic‑NAcc systems coupling to predict depressive symptoms after IL‑17 antagonism 5. The relationship between resting state fMRI functional connectivity between the thalamus and the NAcc and depressive symptoms 6. The ability of resting state fMRI functional connectivity between the thalamus and the NAcc to predict depressive symptoms after IL‑17 antagonism 7. Whether changes in depressive symptoms correlate to peripheral blood immune cell alterations, particularly cells that produce or respond to IL‑17 |
| Ethics approval(s) |
Approved 02/06/2025, Yorkshire & The Humber - South Yorkshire Research Ethics Committee (NHSBT Newcastle Blood Donor Centre, Holland Drive, Newcastle upon Tyne, NE2 4NQ, United Kingdom; no telephone number provided; southyorks.rec@hra.nhs.uk), ref: 25/YH/0039 |
| Health condition(s) or problem(s) studied | Depressive symptoms in people with active psoriatic disease and how IL-17 inhibition affects inflammation in brain and immune processes. |
| Intervention | Randomised placebo-controlled waiting list experimental medicine study. Participants will be randomised 1:1 to either immediately receive (fast-tracked) IL-17 blockade (secukinumab/ bimekizumab/ Ixekizumab) as per normal dose loading regime or a placebo. The duration of placebo exposure is justified on the basis that it is consistent with current local routine screening and waiting times to start biologics from treatment decision. Active treatment period is 6 weeks, with IL 17 inhibitors administered according to the participants local care prescription: • Secukinumab 150mg or 300mg every week for 5 doses; • Bimekizumab 160mg or 320mg every 4 weeks; • Ixekizumab 160mgs for one dose then 80mgs 2 weekly or 4 weekly. • Placebo (normal saline 0.9%) is administered on the same schedule to mirror the chosen biologic. Participants undergo Baseline assessments (Week 0) and Follow-up assessments at Week 6 (Day 42). After 6 weeks, all participants transition back to local standard care, including initiation or continuation of IL-17 inhibitors. Randomisation is performed centrally using a computer generated randomisation system (Interactive Voice Response System) managed by the Robertson Centre for Biostatistics using randomised permuted blocks of variable size. The randomisation schedule is prepared by the study statistician without involvement of the investigators. |
| Intervention type | Other |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) |
|
| Completion date | 31/10/2027 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 74 Years |
| Sex | All |
| Target sample size at registration | 50 |
| Key inclusion criteria | 1. Adults aged 18 years to less than 75 years 2. Diagnosis of PsO or PsA made by a dermatologist or rheumatologist 3. Selected to start secukinumab, bimekizumab, or ixekizumab by their usual dermatology team for PsO or rheumatology team for PsA in line with the drug licence and eligible using NICE or SMC criteria 4. No contraindications to MRI, for example metal fragments or implantable devices not compatible with MRI; no additional x‑ray imaging will be obtained and existing images may be used to check for possible contraindications 5. 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, and negative hepatitis B anti‑core antibody 6. Recent use of intramuscular or intra‑articular steroid injections, but not within 4 weeks prior to baseline 7. Women of child‑bearing potential must be willing to use effective contraception for the study duration 8. Willing to participate and give informed consent |
| Key exclusion criteria | 1. Inability to provide written informed consent 2. Severe physical impairment (e.g. blindness, deafness, paraplegia) 3. Clinically important active infections e.g. active TB 4. History of inflammatory bowel disease 5. Pregnant or breast feeding 6. Severe claustrophobia precluding MRI 7. Contraindications to 7T MRI 8. Confounding neurological disease including MS, stroke, traumatic brain injury 9. Previous exposure to IL‑17A, IL‑17A/F, IL‑17R inhibitors or IL‑23 (p19/p40) inhibitors in the last 6 months 10. Hypersensitivity to any of the excipients in secukinumab, bimekizumab, or ixekizumab 11. Any clinical, psychological, social or geographical reason which, at the investigator’s discretion, would make them unsuitable to take part in the study |
| Date of first enrolment | 27/06/2025 |
| Date of final enrolment | 28/02/2027 |
Locations
Countries of recruitment
- United Kingdom
- Scotland
Study participating centre
Langlands Drive
Queen Elizabeth University Hospital
Glasgow
G51 4LB
Scotland
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 2.1 | 20/03/2026 | 02/04/2026 | No | No |
Additional files
- 49314 ELATE_PROTOCOL_V2.1_20.03.2026_CLEAN.pdf
- Protocol file
Editorial Notes
02/04/2026: Trial's existence confirmed by Yorkshire & The Humber - South Yorkshire Research Ethics Committee.
