Tocilizumab for Painful Chronic Pancreatitis

Sponsor
Soren Schou Olesen
Study ID
NCT06426160
Phase
PHASE2
Status
Recruiting
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Conditions

  • Pancreatitis, Chronic

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tocilizumab 20 MG/ML [Actemra] — DRUG
    Tocilizumab 8 mg/kg every four weeks for 24 weeks.
  • Sodium Chloride 0.9% Inj — DRUG
    Placebo (Sodium chloride) every four weeks for 24 weeks.

Study Details

This placebo-controlled study will investigate the effect of tocilizumab (an anti-interleukin-6 receptor antibody) on symptom burden, physical functioning, and quality of life in patients with chronic pancreatitis.

Key Dates

Start date
May 21, 2024
Status verified
Jun 2024
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
36 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Tocilizumab
    8 mg / kg Tocilizumab will be diluted to a final volume of 100 mL with sterile, non-pyrogenic sodium chloride 9 mg/mL (0.9 %)
  • Placebo Comparator: Placebo
    100 ml sodium chloride 9 mg/mL (0.9 %).

Primary Outcome Measure

The Comprehensive Pain Assessment Tool Short Form (COMPAT-SF) Questionnaire [ Time Frame: The intervention period is 24 weeks (assessed every 4 weeks from baseline to finalization) ]

Central Contacts

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