A safety and efficacy study of ABT-494 in subjects with Giant Cell Arteritis.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

AbbVie Deutschland GmbH & Co. KG

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

Trial duration

5 Apr 2019 → 11 Mar 2025

Decision date (initial)

2024-07-29

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2023-505476-29-00

EudraCT number

2017-003978-13

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

To evaluate the efficacy of ABT-494 in combination with a corticosteroid taper regimen compared to placebo in combination with a corticosteroid taper regimen, as measured by the proportion of subjects in sustained remission at Week 52, and to assess the safety and tolerability of ABT- 494 in subjects with GCA in Period 1.

Secondary objectives 1

1. To evaluate the safety and efficacy of continuing versus withdrawing ABT-494 in maintaining remission in subjects who achieved remission in Period 1.

Conditions and MedDRA coding

Giant Cell Arteritis

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. 1. Diagnosis of GCA according to the following criteria: • Adult male or female, at least 50 years of age • History of ESR ≥ 50 mm/hour or hsCRP/CRP ≥ 1.0 mg/dL • Presence of at least one of the following: • Unequivocal cranial symptoms of GCA, OR • Unequivocal symptoms of PMR • Presence of at least one of the following: • Temporal artery biopsy revealing features of GCA, OR • Evidence of large vessel vasculitis by angiography or cross-sectional imaging (such as magnetic resonance imaging [MRI], computed tomography [CT] or positron emission tomography [PET]) assessed by a qualified radiologist experienced in evaluating large vessel vasculitis, or ultrasound of temporal arteries assessed by a qualified physician experienced in evaluating large vessel vasculitis.
2. 2. Active GCA, either new onset or relapsing, within 8 weeks of study start.
3. 3. Has received treatment with ≥ 40 mg prednisone (or equivalent) at any time prior to study start and be receiving prednisone (or prednisolone) ≥ 20 mg QD at study start.
4. 4. Has GCA that is clinically stable.
5. 5. Females must either be postmenopausal or permanently surgically sterile or, practicing at least 1 specified method of birth control through the study.

Exclusion criteria 5

1. 1. Prior exposure to any JAK inhibitor
2. 2. Treatment with an interleukin-6 (IL-6) inhibitor within 4 weeks of study start, or prior treatment with an IL-6 inhibitor and experienced a disease flare during treatment.
3. 3. Subject must not have received a biologic or non-biologic DMARD within at least five times the mean terminal elimination half-life of the drug, or must follow the washout period specified in the protocol
4. 4. Current or past history of infection including herpes zoster or herpes simplex, HIV, active Tuberculosis, active or chronic recurring infection, active hepatitis B or C.
5. 5. Female who is pregnant, breastfeeding, or considering pregnancy during the study

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The proportion of subjects achieving sustained remission at Week 52 as defined as: • Absence of GCA signs and symptoms from Week 12 through Week 52 • Adherence to the protocol defined corticosteroid taper regimen

Secondary endpoints 8

1. 1. Proportion of subjects achieving sustained complete remission from Week 12 through Week 52
2. 2. Cumulative CS exposure
3. 3. Time to first disease flare. Disease flare is defined as an event determined by the investigator to represent recurrence of GCA signs or symptoms or an ESR measurement > 30 mm/hr attributable to GCA, AND requiring an increase in CS dose.
4. 4. Proportion of subjects who experience at least 1 disease flare through Week 52.
5. 5. Proportion of subjects in complete remission at Week 52. Complete remission is defined as having achieved all of the following: - Absence of GCA signs and symptoms; - Normalization of ESR to < 30 mm/hr; - Normalization of hsCRP to < 1 mg/dL; and - Adherence to the protocol-defined CS taper regimen.
6. 6. Proportion of subjects in complete remission at Week 24.
7. 7. Change from Baseline in the 36-item Short Form Quality of Life Questionnaire (SF-36) Physical Component Score (PCS) at Week 52.
8. 8. Number of disease flares per subject during Period 1. • Change from Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) at Week 52. • Assessment of Treatment Satisfaction Questionnaire for Medication (TSQM) patient global satisfaction subscale at Week 52. • Rate of CS-related AEs.

Investigational products

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

Test 2

Comparator 4

Placebo 5

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

AbbVie Deutschland GmbH & Co. KG

Sponsor organisation

AbbVie Deutschland GmbH & Co. KG

Address

Knollstrasse

City

Ludwigshafen Am Rhein

Postcode

67061

Country

Germany

Scientific contact point

Organisation

AbbVie Deutschland GmbH & Co. KG

Contact name

Global Clinical Trials Helpdesk

Public contact point

Organisation

AbbVie Deutschland GmbH & Co. KG

Contact name

Global Clinical Trials Helpdesk

Third parties 5

Locations

10 EU/EEA countries · 20 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

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 75 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