A Phase 2, Open-label Study to Evaluate the Safety, Tolerability, and Efficacy of Intravenous NVG-2089 in Participants with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Conditions

Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Brief summary

Incidence, nature, and severity of treatment-emergent adverse events (TEAEs), and serious adverse events (SAEs), Clinically significant findings of laboratory, vital signs, electrocardiogram, and physical examinations

Detailed description

Treatment-naïve Participants: Percentage of participants with evidence of clinical improvement (ECI) at Week 14. ECI is defined as improvement of 1 point on the adjusted Inflammatory Neuropathy Cause and Treatment (adjusted INCAT) score, or 4 points on Inflammatory Rasch-built Overall Disability Scale (I-RODS) or 8 kilopascal (kPa) on mean grip strength (dominant hand)., Treatment-experienced Participants: Percentage of participants who meet any of the following conditions: - Achieving ECI at Week 14 - No worsening in adjusted INCAT between Weeks 4 and 14 - Worsening in adjusted INCAT between Day 1 and Week 4 (and have not received rescue medication) followed by an improvement to baseline by Week 4 and maintained through Week 14, Treatment-experienced Participants: Percentage of participants who meet any of the following conditions: - No worsening in adjusted INCAT between Weeks 4 and 14 - Worsening in adjusted INCAT between Day 1 and Week 4 (and have not received rescue medication) followed by an improvement to baseline by Week 4 and maintained through Week 14, Treatment-experienced Participants: Percentage of participants with ECI at Week 14, Change from baseline over time in: - Adjusted INCAT score - Medical Research Council (MRC) sum score - I-RODS disability scores - Mean grip strength, The PK parameters of NVG-2089 concentrations in plasma, Incidence and characteristics of ADA after dosing, PK concentrations and safety profile in participants with ADA

Related papers

No related papers found yet.

Papers published before 2007-09-01 may not appear yet. Historical indexing is in progress.

Interventions

DRUGNVG-2089

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Incidence, nature, and severity of treatment-emergent adverse events (TEAEs), and serious adverse events (SAEs), Clinically significant findings of laboratory, vital signs, electrocardiogram, and physical examinations	—

Secondary

Measure	Time frame
Treatment-naïve Participants: Percentage of participants with evidence of clinical improvement (ECI) at Week 14. ECI is defined as improvement of 1 point on the adjusted Inflammatory Neuropathy Cause and Treatment (adjusted INCAT) score, or 4 points on Inflammatory Rasch-built Overall Disability Scale (I-RODS) or 8 kilopascal (kPa) on mean grip strength (dominant hand)., Treatment-experienced Participants: Percentage of participants who meet any of the following conditions: - Achieving ECI at Week 14 - No worsening in adjusted INCAT between Weeks 4 and 14 - Worsening in adjusted INCAT between Day 1 and Week 4 (and have not received rescue medication) followed by an improvement to baseline by Week 4 and maintained through Week 14, Treatment-experienced Participants: Percentage of participants who meet any of the following conditions: - No worsening in adjusted INCAT between Weeks 4 and 14 - Worsening in adjusted INCAT between Day 1 and Week 4 (and have not received rescue medication) f	—

Measure

Time frame

Treatment-naïve Participants: Percentage of participants with evidence of clinical improvement (ECI) at Week 14. ECI is defined as improvement of 1 point on the adjusted Inflammatory Neuropathy Cause and Treatment (adjusted INCAT) score, or 4 points on Inflammatory Rasch-built Overall Disability Scale (I-RODS) or 8 kilopascal (kPa) on mean grip strength (dominant hand)., Treatment-experienced Participants: Percentage of participants who meet any of the following conditions: - Achieving ECI at Week 14 - No worsening in adjusted INCAT between Weeks 4 and 14 - Worsening in adjusted INCAT between Day 1 and Week 4 (and have not received rescue medication) followed by an improvement to baseline by Week 4 and maintained through Week 14, Treatment-experienced Participants: Percentage of participants who meet any of the following conditions: - No worsening in adjusted INCAT between Weeks 4 and 14 - Worsening in adjusted INCAT between Day 1 and Week 4 (and have not received rescue medication) f

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Countries

Belgium, Bulgaria, France, Italy, Poland, Spain

Outcome results

None listed