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Phase 3 N=568 Randomized Quadruple-blind Treatment

Study to Assess Efficacy and Safety of Cx601, Adult Allogeneic Expanded Adipose-derived Stem Cells (eASC) for the Treatment of Complex Perianal Fistula(s) in Participants With Crohn's Disease (CD)

Crohn's Disease

Enrolled (actual)
568
Serious AEs
13.8%
Results posted
Sep 2024
Primary outcome: Primary: Percentage of Participants With Combined Remission at Week 24 — 46.32; 48.76 percentage of participants — p==0.571

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
Cx601 (Drug); Placebo (Other)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Tigenix S.A.U.
Primary completion
Jan 2023

Outcome Measures

OutcomeResultp-value
PRIMARY
Percentage of Participants With Combined Remission at Week 24
46.32; 48.76 =0.571
SECONDARY
Percentage of Participants With Clinical Remission at Week 24
47.02; 49.82 =0.515
SECONDARY
Time to Clinical Remission at Week 24
7.14; 7.00 =0.374
SECONDARY
Percentage of Participants With Combined Remission at Week 52
39.65; 40.99 =0.757
SECONDARY
Percentage of Participants With Clinical Remission at Week 52
41.40; 43.11 =0.697
SECONDARY
Percentage of Participants With Clinical Response at Week 24
58.60; 61.84 =0.428
SECONDARY
Percentage of Participants With Clinical Response at Week 52
50.88; 53.71 =0.497
SECONDARY
Time to Clinical Remission at Week 52
7.14; 7.00 =0.363
SECONDARY
Time to Clinical Response at Week 24
6.71; 6.71 =0.833
SECONDARY
Time to Clinical Response at Week 52
6.71; 6.71 =0.717
SECONDARY
Percentage of Participants With Relapse by Week 52 After Achieving Combined Remission at Week 24
31.06; 34.06 =0.599
SECONDARY
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (TESAEs), and Treatment-emergent Adverse Events of Special Interest (TEAESIs)
201; 203; 35; 41; 3; 0
SECONDARY
Number of Participants With Clinically Significant Changes in Vital Sign Parameters
0; 0
SECONDARY
Number of Participants With Clinically Significant Changes in Laboratory Parameters
0; 0

Summary

The purpose of this study is to evaluate the combined remission of complex perianal fistulas, defined as the clinical assessment at Week 24 of closure of all treated external openings that were draining at baseline despite gentle finger compression, and absence of collections greater than (>) 2 centimeter (cm) (in at least 2 dimensions) confirmed by blinded central magnetic resonance imaging (MRI) assessment at Week 24.

Eligibility Criteria

Inclusion Criteria

  • Signed informed consent.
  • Participants of either gender greater than or equal to (>=) 18 years and less than or equal to ( =2 external openings.
  • Associated perianal abscess(es). Note: Abscesses that are larger than 2 cm at least 2 dimensions on MRI must be confirmed to have been drained adequately by the surgeon during the preparation curettage in order to be eligible.
  • Clinically controlled, nonactive or mildly active CD, during the last six months prior to Screening visit with:
  • A patient reported outcomes (PRO-2) score =2.0 gram per deciliter (g/dL) or an unexplained rising C-reactive protein (CRP), > 5.0 milligram per liter (mg/L) to a concentration above the referenced upper limit of normal (ULN) (unless the rise is due to a known process other than luminal Crohn's Disease), since the last colonoscopy was performed as compared to results during the Screening visit.

AND

o no initiation or intensification of treatment with corticosteroids, immunosuppressants or monoclonal antibodies (mAbs) dose regimen since the last endoscopy up to Screening visit.

  • Participants whose perianal fistulas were previously treated and have shown an inadequate response or a loss of response while they were receiving either an immunosuppressive agent or tumour necrosis factor (TNF)-alpha antagonist or vedolizumab or ustekinumab, or having documented intolerance to any of these treatments administered at least at approved or recommended doses during the minimum period mentioned:
  • Immunosuppressive agents: at least 3 months treatment with azathioprine (2-3 milligram per kilogram per day [mg/kg/day]), 6-mercaptopurine (1-1.5 mg/kg/day), or subcutaneous/intramuscular methotrexate (25 mg/week) prior to Screening for the study.
  • TNFalpha antagonists:
  • Infliximab: at least 14 weeks treatment at the approved doses for induction and/or maintenance in Crohn´s disease prior to screening for the study. For induction: 1 intravenous dose of 5 milligram per kilogram (mg/kg) followed by the same dose 2 and 6 weeks after. For maintenance: 5-10 mg/kg intravenously every 8 weeks, or more frequently.
  • Adalimumab: at least 14 weeks treatment at the approved doses for induction and/or maintenance in Crohn's disease prior to screening for the study. For induction: 1 subcutaneous dose of 160 milligram (mg), followed by 80 mg 2 weeks after. For maintenance: 40 mg subcutaneously every other week, or weekly.
  • Certolizumab l: at least 14 weeks treatment at the approved doses for induction and/or maintenance in Crohn´s disease prior to screening for the study. For induction: 1 subcutaneous dose of 400 mg, followed by the same dose 2 and 4 weeks after. For maintenance: 400 mg subcutaneously every 2 to 4 weeks.
  • Anti-integrin: at least 14 weeks treatment of the approved dose for induction and/or maintenance in Crohn´s disease prior to screening for the study. For induction: Vedolizumab 300 mg. For maintenance: Vedolizumab 300 mg every 4 to 8 weeks.
  • Anti-interleukin (IL)-12/23: at least 16 weeks treatment of the approved dose in Crohn´s disease prior to screening for the study. For induction: Ustekinumab, approximately 6mg/kg intravenously initially then followed by 90 mg subcutaneously every 8 weeks.
  • Women of childbearing potential (WCBP) must have negative serum pregnancy test at screening (sensitive to 25 international units [IU] human chorionic gonadotropin [hCG]). Both WCBP or male participants participating in this study, with a WCBP as partner, must agree to use an adequate method of contraception during the entire duration of the study. An adequate method of contraception is defined as complete, non-periodic sexual abstinence (refraining from heterosexual intercourse), single-barrier method, vasectomy, adequate hormonal contraception (to have started at least 7 days prior to Screening visit), or an intra-uterine device (to have been in place for at least 2 months prior to Screening visit).

Exclusion Criteria

  • Concomit
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03279081). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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