Rapid pain control in Ixekizumab targeted axial spondyloarthritis

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Universitaetsklinikum Erlangen AöR

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

Trial duration

29 Apr 2024 → 22 Dec 2025

Decision date (initial)

2024-01-29

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Therapy

To evaluate early CNS pain response detected by BOLD signal changes in fMRI of the brain to Ixekizumab treatment

Conditions and MedDRA coding

axial spondyloarthritis

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 10

1. male or female subject aged ≥ 18 years at time of consent
2. understand and voluntarily sign informed consent form
3. able to follow trial instructions and likely to attend and complete all required visits
4. fulfils ASAS classification criteria for axSpA
5. BASDAI > 4
6. VAS pain (0 - 10) > 4
7. indication for systemic treatment with bDMARDs (active disease, inadequate response to 2 NSAIDs at maximum tolerable dosage)
8. current NSAID and/or analgesic therapy at stable dose for at least 2 weeks prior to screening and maintenance for the duration of the trial (if applicable)
9. current Glucocorticoids treatment (≤ 10 mg/day) at stable dose for at least 4 weeks prior to screening and maintenance for the duration of the trial (if applicable)
10. negative pregnancy test in women of childbearing potential (WOCBP) and willing to use at least 1 acceptable method of contraception throughout trial participation and for at least 10 weeks after treatment period

Exclusion criteria 14

1. prior exposure to bDMARDs
2. previous Ixekizumab treatment within 4 weeks (or 5 half-lives, whichever is longer) prior to enrolment
3. any contraindication to perform MRI
4. any severe active infection, e.g. hepatitis B or C, SARS-CoV 2 (COVID 19), or active tuberculosis as defined by a positive Quantiferon Tb-test. (if presence of latent tuberculosis is established then treatment according to local guidelines must have been initiated prior to enrolment) or history of recurrent infections
5. any other autoimmune or inflammatory disease (e.g. but not limited to RA, SLE, SSc, MCTD, Behcet disease, vasculitis, or autoimmune hepatitis)
6. presence of fibromyalgia or other forms of widespread pain at the discretion of the investigator
7. requirement for immunization with live vaccine during trial participation or within the four weeks prior to screening
8. history of venous thrombosis or pulmonary embolism
9. any condition, including the presence of laboratory abnormalities, which would impact the safety of the subject or the interpretation of the trial results
10. history of or presence of inflammatory bowel disease including Crohn’s disease and ulcerative colitis
11. Clinically significant cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, neurologic, gastrointestinal, immunologic, or other major diseases
12. Evidence of severe renal dysfunction defined as: eGFR < 30 ml/min/1,73 m2 (calculated using the MDRD formula) at screening (Visit 1)
13. Evidence of severe hepatic insufficiency defined as Child-Pugh score ≥ 10 (C)
14. treatment with Glucocorticoids of more than 10 mg/day

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Change in fMRI BOLD signal voxel count during initial treatment with Ixekizumab (day 17 vs. day 14) as compared to change in fMRI BOLD signal voxel count during pre-treatment (day 3 vs. day 0)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Universitaetsklinikum Erlangen AöR

Sponsor organisation

Universitaetsklinikum Erlangen AöR

Address

Maximiliansplatz 2, Innenstadt Innenstadt

City

Erlangen

Postcode

91054

Country

Germany

Scientific contact point

Organisation

Universitaetsklinikum Erlangen AöR

Contact name

PD Dr. med. Jürgen Rech

Public contact point

Organisation

Universitaetsklinikum Erlangen AöR

Contact name

PD Dr. med. Jürgen Rech

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Application history

1 submissions — initial application plus substantial / non-substantial modifications