Effects of IL-23 inhibition in patients with very early axial spondyloarthritis – evidence for a true disease modification?

Overview

Sponsor-declared trial summary

Key facts

Sponsor

St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Musculoskeletal Diseases [C05], Diseases [C] - Immune System Diseases [C20]

Trial duration

19 Dec 2024 → ongoing

Decision date (initial)

2024-08-16

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

AbbVie

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

To investigate the effects of risankizumab treatment on disease activity in patients with very early active axSpA

Secondary objectives 1

1. To investigate the effects of risankizumab on MRI related inflammatory lesions and on overall clinical function

Conditions and MedDRA coding

AXIAL SPONDYLOARTHRITIS

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 10

1. A written informed consent form approved by the Institutional Review Board (IRB)/Independent Ethics Committee (IEC) has been signed by the patients.
2. Patients are considered reliable and are able to adhere to the protocol, comply with the schedule of visits, or take medications as judged by the investigator
3. Patients are at least 18 years and not older than 40 years of age at the time of the screening visit
4. Patients must have a documented diagnosis of very early axSpA with symptom duration of at least 3 months but below 2 years
5. Patients must have active disease, at the screening and the baseline visit, defined by: - BASDAI score ≥ 4/10 and spinal pain ≥ 4/10 on an NRS. - Either elevated CRP level and/or current evidence of sacroiliitis on an MRI scan within 3 months prior to baseline
6. Patients must be HLA-B27 positive at screening
7. Patients must have demonstrated intolerance or inadequate response to at least 2 NSAIDs. Inadequate response to an NSAID is defined as a lack of response to at least 14 days of continuous NSAID therapy with the highest tolerated dose of the NSAID administered
8. Patients must not have received pre-treatment b- and ts-DMARDs prior to screening ('bDMARD naïve')
9. Female patients of childbearing potential (FCBP) must use an effective method of contraception (including oral/parenteral/implantable hormonal contraceptives, intrauterine device or barrier, and spermicide or contraceptive methods considered at least as safe for contraception). Exclusive abstinence would not be an acceptable method. FCBP must agree to use effective contraception during the study and for at least 5 months (according to the Summary of Product Characteristics) after the last dose of study treatment. Male subjects who are not documented to be sterile must agree to ensure that they or their partner(s) use adequate contraception for the duration of the study.
10. Baseline-MRI must be available, and patients must agree to the planned MRI procedures

Exclusion criteria 20

1. Patients have participated within the past 3 months or are currently participating in another study with an investigational drug (or medical device)
2. Patients who are unable to speak and read German
3. Patients have a history of chronic alcohol or drug abuse
4. Patients have a medical or psychiatric condition that, in the opinion of the investigator, would jeopardize or impair the ability to participate in this study
5. Patients have a known hypersensitivity to the active substance (risankizumab) or to any of the excipients
6. Patients must not have any other inflammatory arthritis, e.g., RA, systemic lupus erythematosus, sarcoidosis, or others
7. Patients must not have a secondary, non-inflammatory condition (e.g., osteoarthritis or fibromyalgia) that, in the opinion of the investigator, is sufficiently prominent to interfere with the evaluation of the effect of study drug on the primary diagnosis of axial SpA
8. Female patients who are breastfeeding, pregnant, or plan to become pregnant during the study
9. Patients who have received a live vaccination within the last 8 weeks prior to baseline
10. Current malignancy or history of malignancy, although patients with less than 3 completely excised basal cell carcinomas or with one successfully operated cervical carcinoma in situ more than 5 years prior to screening may be included
11. Patients with severe, progressive, and/or uncontrolled renal, hepatic, hematologic, endocrine, pulmonary, cardiac, or neurologic disease or with a history of such disease
12. Patients with any other condition, including the presence of laboratory abnormalities, which, in the judgment of the investigator, makes the subject unsuitable for participation in the study
13. Patients with any contraindication to perform MRI or failure to perform MRI prior to baseline
14. Patients with clinically important active infections
15. Female patients with positive urine pregnancy test
16. Positive interferon gamma release assay (IGRA) test at screening and/or abnormal chest x-ray (within 3 months prior to screening) suggestive for past or present tuberculosis. Patients with positive IGRA test but with negative x-ray and without clinical symptoms for tuberculosis may participate in the study after initiation of standard prophylactic antimycobacterial treatment
17. Chronic infection such as hepatitis B or C infection
18. Immunocompromised patients or history of HIV infection
19. Patients who possibly are dependent on the Sponsor, the Principal Investigator or Investigator (e.g., family members)
20. Have participated in this study before

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Proportion of patients in low disease activity, defined as ASDAS status of <2.1 after 28 weeks of treatment (primary endpoint), assessed 4 weeks after the last injection (week 32 of the study)
2. Proportion of patients who stay in low disease activity for at least 6 months after treatment withdrawal

Secondary endpoints 6

1. Improvement of patient´s global assessment after 28 weeks of treatment, assessed 4 weeks after the last injection (week 32 of the study)
2. Proportion of patients in inactive disease, defined as ASDAS status of <1.3 at week 32 and at week 56
3. Improvement in MRI-related inflammatory lesions (quantified by Berlin score for spine and sacroiliac joints) at week 32 and week 56
4. Proportion of patients with good overall clinical function (ASAS Health Index (HI) ≤ 5) at week 32 and at week 56
5. Proportion of patients with a major clinical response, defined as a 50% improvement of the initial BASDAI (BASDAI 50) after 28 weeks of treatment, assessed 4 weeks after the last injection (week 32 of the study)
6. Change from baseline in BASMI and BASFI after 28 weeks of treatment, assessed 4 weeks after the last injection (week 32 of the study)

Investigational products

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

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr

Sponsor organisation

St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr

Address

Hospitalstrasse 19, Wanne Wanne

City

Herne

Postcode

44649

Country

Germany

Scientific contact point

Organisation

St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr

Contact name

Rheumazentrum Ruhrgebiet

Public contact point

Organisation

St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr

Contact name

Rheumazentrum Ruhrgebiet

Third parties 1

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

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 4 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

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