NCT02108860

Abatacept for the Treatment of Relapsing, Non-Severe, Granulomatosis With Polyangiitis (Wegener's)

Completed Phase 3 Last updated 29 July 2024

What this trial tests

Phase 3 trial testing Abatacept in Granulomatosis With Polyangiitis (Wegener's) in 65 participants. Completed in 20 December 2023.

Timeline

25 April 2015

Primary endpoint
25 July 2023

20 December 2023

Quick facts

Lead sponsor	University of South Florida
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	65
Start date	25 April 2015
Primary completion	25 July 2023
Estimated completion	20 December 2023
Sites	20 locations across Ireland, United Kingdom, Germany, Canada, United States

Drugs / interventions tested

• Abatacept (abatacept) — full drug profile →
• placebo

Conditions studied

• Granulomatosis With Polyangiitis (Wegener's) — all drugs for Granulomatosis With Polyangiitis (Wegener's) →
• Granulomatosis With Polyangiitis — all drugs for Granulomatosis With Polyangiitis →
• Wegener's Granulomatosis — all drugs for Wegener's Granulomatosis →
• ANCA-Associated Vasculitis — all drugs for ANCA-Associated Vasculitis →

Sponsor

University of South Florida

Who can join

15 and older, any sex, with Granulomatosis With Polyangiitis (Wegener's) or Granulomatosis With Polyangiitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Multi-center, randomized, double-blind, placebo-controlled trial to evaluate the efficacy of abatacept to achieve sustained glucocorticoid-free remission in patients with relapsing non-severe granulomatosis with polyangiitis (Wegener's) (GPA) . Participants will be randomized 1:1 to receive either abatacept 125 mg or placebo administered by subcutaneous injection once a week. Participants will continue on study treatment for a minimum of 12 months unless they experience a disease relapse or disease flare.

Participants who experience a non-severe disease relapse, non-severe disease worsening, or who have not achieved remission by month 6 will have the option of entering an open-label trial period whereby they would receive open-label abatacept.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Proteinase 3-ANCA Vasculitis versus Myeloperoxidase-ANCA Vasculitis.
   Hilhorst M, van Paassen P, Tervaert JW, Limburg Renal Registry. · · 2015 · cited 154× · PMID 25956510 · DOI 10.1681/asn.2014090903
2. Targeted Immunotherapy for Autoimmune Disease.
   Jung SM, Kim WU. · · 2022 · cited 113× · PMID 35291650 · DOI 10.4110/in.2022.22.e9
3. ANCA-Associated Vasculitis: An Update.
   Almaani S, Fussner LA, Brodsky S, Meara AS, et al · · 2021 · cited 113× · PMID 33916214 · DOI 10.3390/jcm10071446
4. Updates in ANCA-associated vasculitis.
   Pagnoux C. · · 2016 · cited 89× · PMID 27733943 · DOI 10.5152/eurjrheum.2015.0043
5. Primary Vasculitis in Childhood: GPA and MPA in Childhood.
   Jariwala MP, Laxer RM. · · 2018 · cited 42× · PMID 30167431 · DOI 10.3389/fped.2018.00226
6. T Cells in Autoimmunity-Associated Cardiovascular Diseases.
   Schwartz DM, Burma AM, Kitakule MM, Luo Y, et al · · 2020 · cited 38× · PMID 33117403 · DOI 10.3389/fimmu.2020.588776
7. ANCA-Associated Vasculitic Neuropathies: A Review.
   Koike H, Nishi R, Ohyama K, Morozumi S, et al · · 2022 · cited 34× · PMID 35044596 · DOI 10.1007/s40120-021-00315-7
8. Updates in ANCA-associated vasculitis.
   Ross C, Makhzoum JP, Pagnoux C. · · 2022 · cited 22× · PMID 35156630 · DOI 10.5152/eujrheum.2022.20248