NCT03905109

Phase 2b/3 Study of ABX464 in Moderate to Severe Active Crohn's Disease Patients

Withdrawn Phase 2, PHASE3 Last updated 31 July 2024

What this trial tests

Phase 2, PHASE3 trial testing ABX464 in Crohn Disease. Withdrawn.

Timeline

19 September 2022

Primary endpoint
19 September 2022

19 September 2022

Quick facts

Lead sponsor	Abivax S.A.
Phase	Phase 2, PHASE3
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Start date	19 September 2022
Primary completion	19 September 2022
Estimated completion	19 September 2022
Sites	1 location across Belgium

Drugs / interventions tested

• ABX464 — full drug profile →
• Placebo

Conditions studied

• Crohn Disease — all drugs for Crohn Disease →

Sponsor

Abivax S.A. — full company profile →

Who can join

Adults 18 to 75, any sex, with Crohn Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a multicenter, randomized, placebo controlled study to evaluate the efficacy and safety of ABX464, administered once daily (QD), in inducing clinical remission and endoscopic response in patients with moderate to severe active Crohn's disease (CD) who have inadequate response, loss of response, or intolerance to prior corticosteroid and/or immunosuppressant treatment and/or biologics. This study consists of a 28 day Screening Period, a 52 week Treatment Period; including a 12 week double blinded (Cohort 1) or open label (Cohort 2) Induction Phase and a 40 week double blinded (responders) or open label (nonresponders) Maintenance Phase; and a 4 week Follow up Period, which will consist of an End of Study (EOS) visit

Publications & conference data

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

1. Immunology of Inflammatory Bowel Disease: Molecular Mechanisms and Therapeutics.
   Lu Q, Yang MF, Liang YJ, Xu J, et al · · 2022 · cited 139× · PMID 35310454 · DOI 10.2147/jir.s353038
2. Strategies to Modulate MicroRNA Functions for the Treatment of Cancer or Organ Injury.
   Lee TJ, Yuan X, Kerr K, Yoo JY, et al · · 2020 · cited 55× · PMID 32554488 · DOI 10.1124/pr.119.019026
3. The Role of MicroRNAs in Acute Respiratory Distress Syndrome and Sepsis, From Targets to Therapies: A Narrative Review.
   Lee LK, Medzikovic L, Eghbali M, Eltzschig HK, et al · · 2020 · cited 40× · PMID 33079870 · DOI 10.1213/ane.0000000000005146
4. Targeting miR-30d reverses pathological cardiac hypertrophy.
   Li J, Sha Z, Zhu X, Xu W, et al · · 2022 · cited 39× · PMID 35752105 · DOI 10.1016/j.ebiom.2022.104108
5. miRNA Molecules-Late Breaking Treatment for Inflammatory Bowel Diseases?
   Aggeletopoulou I, Mouzaki A, Thomopoulos K, Triantos C. · · 2023 · cited 22× · PMID 36768556 · DOI 10.3390/ijms24032233
6. Expression, Regulation and Function of microRNA as Important Players in the Transition of MDS to Secondary AML and Their Cross Talk to RNA-Binding Proteins.
   Bauer M, Vaxevanis C, Heimer N, Al-Ali HK, et al · · 2020 · cited 20× · PMID 32992663 · DOI 10.3390/ijms21197140
7. MicroRNA (miR)-124: A Promising Therapeutic Gateway for Oncology.
   Gourishetti K, Balaji Easwaran V, Mostakim Y, Ranganath Pai KS, et al · · 2023 · cited 9× · PMID 37508353 · DOI 10.3390/biology12070922
8. Drug Development in Inflammatory Bowel Diseases: What Is Next?
   Petronio L, Dal Buono A, Gabbiadini R, Migliorisi G, et al · · 2025 · cited 3× · PMID 40006003 · DOI 10.3390/ph18020190