Study of Targeted Therapies for the Treatment of Adult Participants With Moderate to Severe Crohn's Disease

Study acronym: Target CD
StatusRecruiting
PhasePhase 2
SponsorAbbVie
Started

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Record History

The 50 most recent of 129 record versions are listed below. See every version on ClinicalTrials.gov ↗

  1. Trial arms changed: 7 → 8 Show 4 more changesShow less
    • Enrollment target: 540 to 590
    • Eligibility criteria shortened, about 59 words
    • Secondary endpoints: details revised at 3 of 3 entries
    • Study sites revised (255)
  2. Study sites revised (255)v128
  3. Site details revised at 1 of 255 sitesv127
  4. Site details revised at 2 of 255 sitesv126
  5. Primary completion pushed from Dec 2027 to Jan 2030
    • Primary endpoint(s) modified
    • Study completion pushed from Aug 2028 to Jan 2030
    • Study sites: 254 to 255
    v125
Show 45 earlier versionsHide 45 earlier versions
  1. Study sites revised (254)v124
  2. Site details revised at 2 of 254 sitesv123
  3. Site details revised at 1 of 254 sitesv122
  4. Re-verified, no change to tracked fieldsv121
  5. Study sites revised (254)v120
  6. Study sites: 253 to 254v119
  7. Enrollment target: 500 to 540
    • Study sites: 252 to 253
    • Interventions: ABBV-382 (Drug), ABBV-382 (Drug), Lutikizumab (Drug), Risankizumab (Drug), Risankizumab (Drug) to ABBV-8736 (Drug), Lutikizumab (Drug), Risankizumab (Drug), Risankizumab (Drug), Trosunilimab (Drug), Trosunilimab (Drug)
    • Study arms: 6 to 7
    v118
  8. Site details revised at 1 of 252 sitesv117
  9. Site details revised at 1 of 252 sitesv116
  10. Site details revised at 2 of 252 sitesv115
  11. Site details revised at 1 of 252 sitesv114
  12. Study sites: 235 to 252v113
  13. Study sites: 233 to 235v112
  14. Site contacts updated at 1 of 233 sitesv111
  15. Study sites: 232 to 233v110
  16. Study sites: 231 to 232v109
  17. Study sites: 230 to 231v108
  18. Study sites: 229 to 230v107
  19. Study sites: 225 to 229v106
  20. Study sites: 224 to 225v105
  21. Study sites: 223 to 224v104
  22. Study sites revised (223)v103
  23. Study sites: 221 to 223v102
  24. Study sites revised (221)v101
  25. Study sites revised (221)v100
  26. Study sites: 220 to 221v99
  27. Site details revised at 1 of 220 sitesv98
  28. Study sites: 219 to 220v97
  29. Study sites: 217 to 219v96
  30. Study sites revised (217)v95
  31. Re-verified, no change to tracked fieldsv94
  32. Study sites: 216 to 217v93
  33. Study sites revised (216)v92
  34. Study sites: 215 to 216v91
  35. Study sites: 213 to 215v90
  36. Study sites: 212 to 213v89
  37. Study sites: 211 to 212v88
  38. Study sites: 210 to 211v87
  39. Study sites: 209 to 210v86
  40. Study sites revised (209)v85
  41. Study sites: 208 to 209v84
  42. Study sites: 207 to 208v83
  43. Study sites: 204 to 207v82
  44. Re-verified, no change to tracked fieldsv81
  45. Study sites: 203 to 204v80
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
AbbVie
349 trials monitored
See 27 trials at risk
Crohn's Disease
643 trials monitored
See 36 trials at risk
Crohn's disease (CD) is a long-lasting disease that causes severe inflammation (redness, swelling), in the digestive tract, most frequently affecting the bowels. It can cause many different symptoms including belly pain, diarrhea, tiredness, and weight loss. Treatments are available but do not work the same for all patients or may stop working over time. This study will evaluate the effectiveness and adverse events of targeted therapies (TaTs) for adult participants with moderate to severe CD. The medicines assessed in this study are risankizumab, trosunilimab, lutikizumab, and ABBV-8736. When participants join the study, they will be randomized into available study treatment groups. Adult participants with CD will be enrolled. Around 590 participants will be enrolled in the study at approximately 300 sites worldwide. Risankizumab and trosunilimab are given as an injection under the skin or as an infusion into the vein. Lutikizumab is given as an injection under the skin. ABBV-8736 is given as an infusion into the vein. There may be higher treatment burden for participants in this trial compared to their standard of care treatment without participating in this study. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, endoscopies, checking for side effects and completing questionnaires and a daily diary.
Trial Details
NCT Number NCT06548542
Lead Sponsor AbbVie
Conditions
(from sponsor)		 Crohn's Disease
Related terms Crohn Disease
Enrollment 590 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov