Daphne

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Rigshospitalet

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Musculoskeletal Diseases [C05]

Trial duration

28 Aug 2024 → ongoing

Decision date (initial)

2024-04-05

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Funding sources

Eli Lilly

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

To assess the effect of ixekizumab (IXE) on the total inflammatory burden in the entire body (peripheral and axial joints and entheses) of patients with axSpA and PsA, as assessed by WB-MRI

Conditions and MedDRA coding

Axial Spondyloarthritis

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Inclusion criteria for both groups Age ≥ 18 years at the time of consent. Clinical indication for a biologic drug as assessed by the treating physician. Sufficient contraception for women. Subjects must be able and willing to provide written informed consent and comply with the requirements of the study protocol.
2. Inclusion criteria for patients with axSpA • AxSpA according to ASAS classification criteria for axSpA • Active inflammation on MRI of the SIJs and/or spine as evaluated by a central SpA imaging expert and/or radiographic modified New York criteria fulfilled as judged by a central SpA imaging expert. • Total back pain as measured on a VAS scale ≥ 40 mm (0-100 mm) at baseline.
3. Inclusion criteria for patients with PsA • PsA according to CASPAR criteria. • Negative rheumatoid factor (RF) and anti-cyclic citrullinated peptide (anti-CCP). • For patients with axial PsA involvement: o Imaging documented axial involvement on MRI, X-ray, or low-dose CT as judged by a central SpA imaging expert. • A minimum of 1 tender and swollen joint in addition to 2 further anatomical localizations with clinical signs of inflammation (i.e., tender enthesis and/or tender and/or swollen joint) assessed at screening and baseline.

Exclusion criteria 1

1. • Contraindications for ixekizumab. • Contraindication for MRI. • Previous exposure to ixekizumab or other biologic drug directly targeting IL-17 or IL-17 receptor • Has received more than 1 prior anti-TNF inhibitor • Previous exposure to other types of bDMARDs than TNF inhibitor. • Active inflammatory bowel disease • DMARDs are allowed during the study, but the dose cannot be changed from 1 month before the first MRI. • Use of any investigational drug and/or devices within 1 month before randomization or a period of 5 half-lives of the investigational drug, whichever is longer. • Any use of oral, intravenous, intra-articular, or intra-muscular corticosteroids within 1 month before the baseline MRI. • Pregnant or nursing (lactating) women. • Known recent drug or alcohol abuse. • Known severe psychiatric disease. • Incapable of complying with the examination program for physical or mental reasons. • Unable to speak, read, or understand Danish.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Change from baseline to month 12 in total inflammatory burden in the entire body (peripheral and axial joints and entheses), as assessed by WB-MRI, in patients with axSpA and PsA treated with IXE

Investigational products

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

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Rigshospitalet

Sponsor organisation

Rigshospitalet

Address

Valdemar Hansens Vej 1-23

City

Glostrup

Postcode

2600

Country

Denmark

Scientific contact point

Organisation

Rigshospitalet

Contact name

Mikkel Østergaard

Public contact point

Organisation

Rigshospitalet

Contact name

Mikkel Østergaard

Third parties 1

Locations

1 EU/EEA country · 4 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 7 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