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CAPTIVATENCT06858579

A Study to Evaluate the Efficacy and Safety of DNTH103 in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CAPTIVATE)

StatusRecruiting
PhasePhase 3
Primary completion (estimated)
Track this trial

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Record History

All 29 versions: 28 with changes below, 1 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Trial sites expanded: 192 → 201 locations
  2. Eligibility criteria expanded, about 25 words
    • Study sites: 192 to 191
    • Secondary endpoints: details revised at 4 of 17 entries
    • Study description expanded, about 4 words
  3. Trial sites expanded: 188 → 192 locationsv27
  4. Trial sites expanded: 180 → 188 locationsv26
  5. Trial sites expanded: 168 → 180 locationsv25
  6. Study sites: 167 to 168v24
  7. Trial sites expanded: 158 → 167 locationsv23
  8. Enrollment reduced: 480 → 256 participantsv22 Show 5 more changesShow less
    • Eligibility criteria revised
    • Trial arms changed: 5 → 4
    • Interventions: DNTH103 (Drug), DNTH103 (Drug), Placebo (Drug) to Claseprubart (Drug), Claseprubart (Drug), Placebo (Drug)
    • Secondary endpoints revised (17)
    • Site details revised at 5 of 158 sites
  9. Study sites: 139 to 158v21
  10. Study sites: 126 to 139v20
  11. Study sites: 120 to 126v19
  12. Study sites: 104 to 120v18
  13. Study sites: 93 to 104v17
  14. Study sites: 87 to 93v16
  15. Study sites: 86 to 87v15
  16. Study sites: 63 to 86v14
  17. Eligibility criteria expanded, about 20 wordsv13
  18. Study sites: 54 to 63v12
  19. Eligibility criteria shortened, about 25 words
    • Study sites: 48 to 54
    • Secondary endpoints revised (17)
    v11
  20. Study sites: 45 to 48v10
  21. Study sites: 35 to 45v9
  22. Study sites: 24 to 35v8
  23. Study sites: 19 to 24v7
  24. Study sites: 13 to 19v6
  25. Study sites: 10 to 13v4
  26. Study sites: 8 to 10v3
  27. Study sites: 1 to 8v2
  28. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Part B: Time From First Dose to Relapse as Assessed by the Adjusted Inflammatory Neuropathy Cause and Treatment (INCAT)
Timeframe: Part B baseline to Part B end of treatment period (up to Week 52)

Secondary (17)

Part B: Time to Decrease of ≥ 4 Points (Centile Metric) in Inflammatory Rasch-built Overall Disability Scale (I-RODS) Score
Part B: Time to Decrease of ≥ 8 kilopascal (kPa) in Grip Strength in the Dominant Hand
Part B: Percentage of Participants who Relapse as Assessed by the Adjusted INCAT
Parts A and B: Change in I-RODS Score (Centile Metric)
Parts A and B: Change in Grip Strength in the Dominant Hand
Show 12 moreShow less
Parts A and B: Change in Adjusted INCAT Score
Parts A and B: Change in Grip Strength in the Nondominant Hand
Parts A and B: Change in Medical Research Council Sum Score (MRC-SS)
Part A: Percentage of Participants with a Confirmed Response to DNTH103 as Assessed by the Adjusted INCAT
Parts A and B: Change in Euro-Quality of Life Visual Analogue Scale (EQ-VAS)
Parts A and B: Change in Fatigue Severity Scale (FSS)
Parts A and B and OLE: Change in Adjusted INCAT Score
Part B and OLE: Percentage of Participants With a Confirmed Relapse as Assessed by the Adjusted INCAT
Parts A, B, OLE, and Safety Follow-up: Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (SAEs)
Parts A, B, OLE, and Safety Follow-up: Serum Concentrations of DNTH103
Parts A, B, and OLE: Change from Baseline in Complement Total Blood Test (CH50)
Parts A, B, OLE, and Safety Follow-up: Incidence and Titer of Antidrug Antibodies (ADAs)

Arms and interventions

Claseprubart (Part A)Experimental

Claseprubart intravenous (IV) loading dose on Day 1. Claseprubart subcutaneous (SC) once every 2 weeks for up to 13 weeks.

Claseprubart (Part B)Experimental

Claseprubart SC once every 2 weeks for up to 52 weeks.

Placebo (Part B)Placebo comparator

Placebo SC once every 2 weeks for up to 52 weeks.

Claseprubart (Optional OLE)Experimental

Claseprubart SC once every 2 weeks for up to 104 weeks.

Drugs: Claseprubart, Placebo

Sites

201 sites in 31 countries

United States 32, China 18, Italy 17, Japan 13, France 12, Malaysia 12, Argentina 9, Brazil 9, Poland 8, Thailand 8, South Korea 7, Australia 6, Germany 6, Spain 5, Turkey (Türkiye) 5, Philippines 4, Serbia 4, Colombia 3, Israel 3, Belgium 2, Bulgaria 2, Denmark 2, Latvia 2, Netherlands 2, Romania 2, United Kingdom 2, Vietnam 2, Croatia 1, Eswatini 1, Georgia 1, North Macedonia 1