Psoriatic ArthritisELATENCT06786936
Evaluating the Role of IL-17 as an Orchestrator of Peripheral-central Cross Talk in Depressive Symptoms
An observational study of Psoriatic Arthritis and Depression, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
Trial summary
The investigators seek clinically actionable understanding of the mechanisms that underlie depression in the context of immune mediated inflammatory diseases (IMIDs), delivered by a focused immune intervention study examining brain circuitry using state of the art imaging in the context of exquisitely specific… Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Psoriatic Arthritis, Depression, Psoriatic Plaque
- What is being tested?
- Secukinumab, Bimekizumab and Ixekizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Jun 2025to 30 Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- All sexes
- Adult, Older adult
Study population: 50 participants with active PsD attending clinics in NHS Greater Glasgow and Clyde, NHS Grampian, NHS Lothian, NHS Tayside, NHS Lanarkshire, NHS Forth Valley starting IL-17 antagonism as part of their usual care by either their NHS dermatology clinical care team for psoriasis, or NHS rheumatology clinical care team for PsA, and in line with the licence and SMC/NICE guidance for these agents. The decision to prescribe anti-IL17 treatment for active PsD will be made by the patients' clinical team in advance, and independently, of the study.
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Neil Basu, MD, PhD contact
United Kingdom1 site, 1 recruiting
- Recruiting
Queen Elizabeth University Hospital
Glasgow, Scotland, G51 4TF
Maxine Arnott, 07890059695, maxine.arnott@glasgow.ac.uk
Neil Basu, MD, PhD
About this study
The investigators seek clinically actionable understanding of the mechanisms that underlie depression in the context of immune mediated inflammatory diseases (IMIDs), delivered by a focused immune intervention study examining brain circuitry using state of the art imaging in the context of exquisitely specific therapeutic immune interception in human immune disease.
Glutamate concentration in the NAcc will be positively correlated with the magnitude of the inflammatory response and will be attenuated by IL-17A inhibition. Ultimately, this will be associated with an improvement in depressive symptoms.
Read more
The strength of coupling between early and late systems will be attenuated in the context of IL-17A-driven inflammation and will be correlated with less frequent switching behaviour following negative outcomes and ultimately depressive symptoms. This coupling will be re-established following IL-17 antagonism.
Patients whose depressive symptoms benefit most from IL-17A antagonism will exhibit greatest resting-state and task-specific functional connectivity between Th-NAcc.
Read the detailed description
Approximately 30-40% of patients with immune-mediated inflammatory diseases (IMIDs), such as psoriatic disease, experience depression. These symptoms negatively affect clinical outcomes, quality of life and treatment adherence. There is accumulating evidence that peripheral inflammation may contribute to the origins of depression. In particular, a) stimulation of active phase inflammation results in remitting-relapsing depressive symptoms b) abnormal neural connectivity linked to this depression is correlated with peripheral inflammation and c) biologic therapies targeting specific peripheral inflammation components (cytokines) improve depressive symptoms.
In this proposal, psoriatic disease (PsD), encompassing both psoriasis and PsA, will be our IMID exemplar. In this condition, the IL-23/IL-17 cytokine axis is central to pathogenesis, as proven by successful application of inhibitors to this pathway. Moreover, this axis has also recently been implicated in the neurobiology of depression in both preclinical and clinical studies.
The investigators aim to uncover the mechanisms that underlie depression in the context of IMIDs, delivered by a focused immune intervention study examining brain circuitry using state of the art imaging in the context of exquisitely specific therapeutic immune interception in human immune disease.
The rationale for this study is to use this specific therapeutic immune intervention to leverage mechanistic understanding of brain changes that drive depressive symptoms. Prior animal studies have clearly demonstrated the deleterious effects of proinflammatory cytokines on neural functioning. The investigators will integrate current therapy with innovative neuroimaging technologies to obtain data for the first time in humans that have hitherto only been possible in animal studies.
The intervention tools proposed herein (secukinumab, bimekizumab or Ixekizumab) are IL-17 inhibitors licensed for treatment of active PsO and PsA. Secukinumab, bimekizumab and Ixekizumab are widely used in clinical practice globally and across the UK as a first/second-line biologic disease modifying antirheumatic drug (DMARD), in line with national/international NICE (TA350, TA445, TA723, TA916, TA442, TA537) treatment recommendations. Secukinumab is given by self-administered subcutaneous injection weekly for the first five weeks of treatment and thereafter by monthly maintenance injections. Bimekizumab is given by self-administered subcutaneous injection 4 weekly, Ixekizumab is given by self -administered subcutaneous injection either 2 or 4 weekly. Typically, depressive symptoms are attenuated within weeks of therapeutic initiation. Prior study data indicate a beneficial effect of IL17 antagonism on depressive symptoms, but the mechanism of action has not yet been explored.
- Conditions
- Psoriatic Arthritis, Depression, Psoriatic Plaque
- Being tested
- Secukinumab, Bimekizumab, Ixekizumab, Placebo
- Medical subject headings
- Arthritis, Psoriatic, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SecukinumabDrug
Also called N/A (Not applicable)
Initial dosing of Secukinimab at week 0, 1, 2, 3, 4 and maintenance doses will be determined by the standard care team. This will be 150mg or 300mg. This will be administered by the study team once confirmed and randomisation has occurred for secukinimab/ placebo allocation.
BimekizumabDrug
Also called N/A (Not applicable)
Initial dosing of bimkizumab at week 0 \& 4 and maintenance doses will be determined by the standard care team. This will be 160mg or 320mg. This will be administered by the study team once confirmed and randomisation has occurred for bimekizumab/ placebo allocation.
IxekizumabDrug
Also called N/A (Not applicable)
Initial dosing of Ixekizumab at week 0 \& 4 or week 0, 2 \& 4, maintenance doses will be determined by the standard care team. The initial dose will be 160mgs then 80mg dose will either be given 2 or 4 weekly. This will be administered by the study team once confirmed and randomisation has occurred for Ixekizumab/ placebo allocation.
PlaceboDrug
Also called N/A (Not applicable)
Sodium chloride 0.9% for injection will be used as a placebo. A 1ml volume will be drawn up into a suitable sized syringe and labelled in accordance with standard practice at site. The dose will be administered as a subcutaneous injection in line with the Secukinumab/ Bimekizumab/ Ixekizumab dosing regimen. No dose adjustments are permitted.
| Study group | Role | What they receive |
|---|---|---|
| Psoriatic Disease | Encompasses both Psoriatic Arthritis and and Plague Psoriasis . Receives: Drug: Secukinumab; Drug: Bimekizumab; Drug: Ixekizumab; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in glutamate concentration in the NAcc as measured by 7T MRS.
Changes in glutamate concentration in the NAcc as measured by 7T MRS, from Week 0 to Week 6 (before and after IL17 antagonism).
Measured: Week 0 to Week 6
Secondary outcomes (2)
Differences in the EEG amplitude during positive and negative response outcomes.
Changes in the EEG amplitude between the thalamic and NAcc learning systems before and after IL-17 antagonism.
Measured: Week 0 to Week 6
Correlating fMRI signals with differences in EEG amplitude.
fMRI signals that correlate with the changing EEG amplitude, before and after IL17 antagonism.
Measured: Week 0 to Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2025
- Study start2 Jun 2025
- Primary completion28 Feb 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriatic ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Collaborators
- University of Glasgow, Medical Research Council
- Responsible party
- Sponsor
- Investigators
- Jonathan Cavanagh, MD, PhD, Principal investigator, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06786936
- Sponsor's protocol ID
- GN22MH376
- Acronym
- ELATE
- Status last verified
- Jun 2025
- First submitted
- 9 Jan 2025
- Last updated
- 19 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Analysed by the study team at University of Glasgow.
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Role of IL-17 as an Orchestrator of Peripheral-central Cross Talk in Depressive Symptoms
- ClinicalTrials.gov ID
- NCT06786936
- Acronym / sponsor ID
- ELATE / GN22MH376
- Conditions
- Psoriatic Arthritis, Depression, Psoriatic Plaque
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Collaborators
- University of Glasgow, Medical Research Council
- Study start
- 2 Jun 2025 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 22 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators seek clinically actionable understanding of the mechanisms that underlie depression in the context of immune mediated inflammatory diseases (IMIDs), delivered by a focused immune intervention study examining brain circuitry using state of the art imaging in the context of exquisitely specific therapeutic immune interception in human immune disease.
Glutamate concentration in the NAcc will be positively correlated with the magnitude of the inflammatory response and will be attenuated by IL-17A inhibition. Ultimately, this will be associated with an improvement in depressive symptoms.
The strength of coupling between early and late systems will be attenuated in the context of IL-17A-driven inflammation and will be correlated with less frequent switching behaviour following negative outcomes and ultimately depressive symptoms. This coupling will be re-established following IL-17 antagonism.
Patients whose depressive symptoms benefit most from IL-17A antagonism will exhibit greatest resting-state and task-specific functional connectivity between Th-NAcc.
Detailed description
Approximately 30-40% of patients with immune-mediated inflammatory diseases (IMIDs), such as psoriatic disease, experience depression. These symptoms negatively affect clinical outcomes, quality of life and treatment adherence. There is accumulating evidence that peripheral inflammation may contribute to the origins of depression. In particular, a) stimulation of active phase inflammation results in remitting-relapsing depressive symptoms b) abnormal neural connectivity linked to this depression is correlated with peripheral inflammation and c) biologic therapies targeting specific peripheral inflammation components (cytokines) improve depressive symptoms.
In this proposal, psoriatic disease (PsD), encompassing both psoriasis and PsA, will be our IMID exemplar. In this condition, the IL-23/IL-17 cytokine axis is central to pathogenesis, as proven by successful application of inhibitors to this pathway. Moreover, this axis has also recently been implicated in the neurobiology of depression in both preclinical and clinical studies.
The investigators aim to uncover the mechanisms that underlie depression in the context of IMIDs, delivered by a focused immune intervention study examining brain circuitry using state of the art imaging in the context of exquisitely specific therapeutic immune interception in human immune disease.
The rationale for this study is to use this specific therapeutic immune intervention to leverage mechanistic understanding of brain changes that drive depressive symptoms. Prior animal studies have clearly demonstrated the deleterious effects of proinflammatory cytokines on neural functioning. The investigators will integrate current therapy with innovative neuroimaging technologies to obtain data for the first time in humans that have hitherto only been possible in animal studies.
The intervention tools proposed herein (secukinumab, bimekizumab or Ixekizumab) are IL-17 inhibitors licensed for treatment of active PsO and PsA. Secukinumab, bimekizumab and Ixekizumab are widely used in clinical practice globally and across the UK as a first/second-line biologic disease modifying antirheumatic drug (DMARD), in line with national/international NICE (TA350, TA445, TA723, TA916, TA442, TA537) treatment recommendations. Secukinumab is given by self-administered subcutaneous injection weekly for the first five weeks of treatment and thereafter by monthly maintenance injections. Bimekizumab is given by self-administered subcutaneous injection 4 weekly, Ixekizumab is given by self -administered subcutaneous injection either 2 or 4 weekly. Typically, depressive symptoms are attenuated within weeks of therapeutic initiation. Prior study data indicate a beneficial effect of IL17 antagonism on depressive symptoms, but the mechanism of action has not yet been explored.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Psoriatic Disease | – | Drug: Secukinumab, Drug: Bimekizumab, Drug: Ixekizumab, Drug: PlaceboEncompasses both Psoriatic Arthritis and and Plague Psoriasis . |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 50 participants with active PsD attending clinics in NHS Greater Glasgow and Clyde, NHS Grampian, NHS Lothian, NHS Tayside, NHS Lanarkshire, NHS Forth Valley starting IL-17 antagonism as part of their usual care by either their NHS dermatology clinical care team for psoriasis, or NHS rheumatology clinical care team for PsA, and in line with the licence and SMC/NICE guidance for these agents. The decision to prescribe anti-IL17 treatment for active PsD will be made by the patients' clinical team in advance, and independently, of the study.
Key inclusion criteria (8 listed)
- 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])
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SecukinumabAlso: N/A (Not applicable)Initial dosing of Secukinimab at week 0, 1, 2, 3, 4 and maintenance doses will be determined by the standard care team. This will be 150mg or 300mg. This will be administered by the study team once confirmed and randomisation has occurred for secukinimab/ placebo allocation. | Drug | Psoriatic Disease |
| BimekizumabAlso: N/A (Not applicable)Initial dosing of bimkizumab at week 0 \& 4 and maintenance doses will be determined by the standard care team. This will be 160mg or 320mg. This will be administered by the study team once confirmed and randomisation has occurred for bimekizumab/ placebo allocation. | Drug | Psoriatic Disease |
| IxekizumabAlso: N/A (Not applicable)Initial dosing of Ixekizumab at week 0 \& 4 or week 0, 2 \& 4, maintenance doses will be determined by the standard care team. The initial dose will be 160mgs then 80mg dose will either be given 2 or 4 weekly. This will be administered by the study team once confirmed and randomisation has occurred for Ixekizumab/ placebo allocation. | Drug | Psoriatic Disease |
| PlaceboAlso: N/A (Not applicable)Sodium chloride 0.9% for injection will be used as a placebo. A 1ml volume will be drawn up into a suitable sized syringe and labelled in accordance with standard practice at site. The dose will be administered as a subcutaneous injection in line with the Secukinumab/ Bimekizumab/ Ixekizumab dosing regimen. No dose adjustments are permitted. | Drug | Psoriatic Disease |
Primary outcome
Changes in glutamate concentration in the NAcc as measured by 7T MRS.
Time frame: Week 0 to Week 6
Changes in glutamate concentration in the NAcc as measured by 7T MRS, from Week 0 to Week 6 (before and after IL17 antagonism).
2 secondary outcomes
Differences in the EEG amplitude during positive and negative response outcomes.
Time frame: Week 0 to Week 6
Correlating fMRI signals with differences in EEG amplitude.
Time frame: Week 0 to Week 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2025.
- Individual participant dataSharing planned: No. Analysed by the study team at University of Glasgow.
Related trials for Psoriatic Arthritis
Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Recruiting
Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis
Rhumatoid Arthisis, Spondyloarthritis (SA)
RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Psoriatic Arthritis, Axial Spondyloarthritis
RecruitingPhase 4
Impact of Glucagon-like Peptide-1 (GLP-1) Analogs on Disease Outcomes in Psoriatic Arthritis: A Pragmatic Randomized Controlled Trial
Psoriatic Arthritis (PsA)
Active, not recruitingPhase 3
Guselkumab vs Golimumab in PsA TNF Inadequate Responder Patients
Psoriatic Arthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Neil Basu, MD, PhD contact
Jonathan Cavanagh, MD, PhD principal investigator
University of Glasgow
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriatic Arthritis and Depression, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maxine Arnott, BSc (07890 059695, maxine.arnott@glasgow.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in glutamate concentration in the NAcc as measured by 7T MRS. (time frame: Week 0 to Week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2025.