Alfasigma S.p.A.

Pediatric Rheumatology and Inflammatory Joint Disorders

The sponsor maintains an active research programme in pediatric rheumatology, with particular emphasis on juvenile idiopathic arthritis and its various manifestations. Research efforts concentrate on understanding disease mechanisms in children and adolescents, exploring therapeutic interventions specifically designed for younger patient populations. The programme includes investigations into polyarticular-course juvenile idiopathic arthritis, addressing the unique challenges of managing chronic inflammatory joint conditions in developing patients.

  • Pharmacokinetic characterization in pediatric populations
  • Safety and tolerability assessment in children and adolescents
  • Long-term extension studies in juvenile arthritis
  • Treatment efficacy evaluation in polyarticular disease

The research extends to evaluating treatment responses across different age groups within the pediatric spectrum, from school-age children through adolescence, ensuring comprehensive understanding of therapeutic profiles in growing patients.

Adult Rheumatoid Arthritis

A significant focus area encompasses rheumatoid arthritis in adult populations, with research directed toward understanding long-term treatment outcomes and sustained therapeutic benefits. The sponsor investigates approaches to managing signs and symptoms of this chronic autoimmune condition, with particular attention to maintaining disease control over extended periods. Studies explore both the immediate therapeutic effects and the durability of treatment responses in patients with established disease.

  • Long-term safety monitoring in rheumatoid arthritis
  • Efficacy assessment in active disease states
  • Treatment maintenance and sustained response

The research programme includes open-label extension protocols designed to capture comprehensive safety data and evaluate the continued effectiveness of interventions beyond initial treatment periods.

Inflammatory Bowel Disease

The sponsor demonstrates substantial commitment to ulcerative colitis research, investigating therapeutic strategies for both disease induction and maintenance phases. Research activities encompass adult and pediatric ulcerative colitis populations, examining approaches to achieving and sustaining remission in patients with active inflammatory bowel disease. The programme addresses the complex nature of intestinal inflammation and explores interventions aimed at controlling disease activity across different patient demographics.

  • Remission induction in active ulcerative colitis
  • Maintenance of therapeutic effect
  • Pediatric inflammatory bowel disease management
  • Long-term safety in ulcerative colitis populations

Extension studies form an integral component of this research area, enabling longitudinal assessment of treatment safety and effectiveness in patients who have completed primary intervention protocols.

Axial Spondyloarthritis

The research portfolio includes investigation of axial spondyloarthritis, a chronic inflammatory condition affecting the spine and sacroiliac joints. The sponsor’s work in this domain focuses on evaluating therapeutic interventions for patients with active disease, contributing to the understanding of treatment options for this debilitating condition. Research activities examine the impact of interventions on disease activity and patient outcomes in this specific form of inflammatory arthritis.

  • Treatment evaluation in active axial spondyloarthritis
  • Assessment of therapeutic efficacy in spinal inflammation

The programme employs comprehensive evaluation methodologies to assess treatment responses and monitor disease progression in affected individuals.

Gastrointestinal Motility Disorders

The sponsor engages in research addressing chronic intestinal pseudo-obstruction, a rare and challenging gastrointestinal motility disorder. This work includes pharmacokinetic profiling and bioavailability studies of therapeutic agents, examining both intravenous and oral formulation characteristics. Research activities incorporate detailed assessment of drug absorption, distribution, and systemic exposure following different routes of administration.

  • Absolute bioavailability determination
  • Pharmacokinetic characterization across formulations
  • Treatment approaches for intestinal motility disorders

The investigation encompasses comparative studies of different delivery methods to optimize therapeutic approaches for patients with complex gastrointestinal dysfunction.

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Matched clinical trials

  • A study to evaluate the safety and effectiveness of filgotinib in children and adolescents aged 8 to 17 years with polyarticular juvenile idiopathic arthritis

    Recruiting

    3 1 1 1
    Investigated drugs:
    Belgium Bulgaria Czechia France Germany Greece +4
  • A study to evaluate the safety and effectiveness of filgotinib in children and adolescents with juvenile idiopathic arthritis.

    Recruiting

    3 1 1 1
    Investigated drugs:
    France Germany
  • Study on the Effects of Filgotinib for Children and Teenagers with Moderate to Severe Ulcerative Colitis

    Recruiting

    3 1 1 1
    Investigated drugs:
    Belgium Croatia France Germany Greece Ireland +6
  • Long-term safety study of filgotinib tablets in adults with ulcerative colitis who completed previous filgotinib treatment

    Not recruiting

    3 1 1
    Investigated drugs:
    Hungary
  • Study on the Long-Term Safety and Effectiveness of Filgotinib for Patients with Rheumatoid Arthritis

    Not recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Bulgaria Germany Hungary
  • Study on Filgotinib for Children and Teens with Juvenile Idiopathic Arthritis

    Not recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    France Germany Poland Spain