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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Dianthus Therapeutics
Study ID
NCT06858579
Phase
PHASE3
Status
Recruiting
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Conditions

  • Chronic Inflammatory Demyelinating Polyneuropathy

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Claseprubart — DRUG
    IV Infusion
  • Claseprubart — DRUG
    SC injection
  • Placebo — DRUG
    SC injection

Study Details

The purpose of this Phase 3 study is to demonstrate the efficacy of claseprubart (DNTH103) as compared to placebo in participants with chronic inflammatory demyelinating polyneuropathy (CIDP).

Key Dates

Start date
Feb 10, 2025
Status verified
Apr 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2030

Study Design

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

Arms

  • Experimental: Claseprubart (Part A)
    Claseprubart intravenous (IV) loading dose on Day 1. Claseprubart subcutaneous (SC) once every 2 weeks for up to 13 weeks.
  • Experimental: Claseprubart (Part B)
    Claseprubart SC once every 2 weeks for up to 52 weeks.
  • Placebo Comparator: Placebo (Part B)
    Placebo SC once every 2 weeks for up to 52 weeks.
  • Experimental: Claseprubart (Optional OLE)
    Claseprubart SC once every 2 weeks for up to 104 weeks.

Primary Outcome Measure

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

Central Contacts

Locations (31)

FacilityCityStateZIPSite coordinators
Clinical Study SiteBirminghamAlabama35294-
Clinical Study SitePhoenixArizona85028-
Clinical Study SiteScottsdaleArizona85251'-
Clinical Study SiteLos AngelesCalifornia90048-
Clinical Study SiteSan FranciscoCalifornia94109-
Clinical Study SiteSan FranciscoCalifornia94158-
Clinical Study SiteWashington D.C.District of Columbia20007-
Clinical Study SiteMaitlandFlorida32751-
Clinical Study SiteTampaFlorida33620-
Clinical Study SiteHonoluluHawaii96817-
Clinical Study SiteChicagoIllinois60611-
Clinical Study SiteEdwardsvilleIllinois62025-
Clinical Study SiteIndianapolisIndiana46202-
Clinical Study SiteKansas CityKansas66160-
Clinical Study SiteBurlingtonMassachusetts01805-
Clinical Study SiteEast LansingMichigan48824-
Clinical Study SiteOmahaNebraska68198-
Cinical Study SiteLebanonNew Hampshire03766-
Clinical Study SiteNew YorkNew York10021-
Clinical Study SiteNew YorkNew York10032-
Clinical Study SiteCincinnatiOhio45219-
Clinical Study SiteColumbusOhio43221-
Clinical Study SitePortlandOregon97239-
Cinical Study SiteNashvilleTennessee37232-
Clinical Study SiteDallasTexas75243-
Clinical Study SiteDentonTexas76208-
Cinical Study SiteHoustonTexas77030-
Texas LocationsHoustonTexas77054-
Clinical Study SiteRound RockTexas78681-
Clinical Study SiteSugar LandTexas77478-
Clinical Study SiteSeattleWashington98195-

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By research site
Clinical Study Site· Birmingham, ALClinical Study Site· Phoenix, AZClinical Study Site· Scottsdale, AZClinical Study Site· Los Angeles, CAClinical Study Site· San Francisco, CAClinical Study Site· Washington D.C., DC

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