Phase
Condition
N/ATreatment
DNTH103
Placebo
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Must have given written informed consent before any study-related activities arecarried out
Adult males and females, 18 to 75 years of age (inclusive).
Weight range between 40 to 120 kilograms (kg).
Confirmed diagnosis of definite or probable MMN.
Evidence of:
Responsiveness to Ig treatment; and
Receiving a stable Ig regimen
Documented vaccinations against encapsulated bacteria in accordance with localrequirements and vaccine availability.
Female participants must be of nonchildbearing potential or if of childbearingpotential, must agree not to donate ova, not to attempt to become pregnant and, ifengaging in sexual intercourse with a male partner, must agree to use a highlyeffective method of contraception.
Male participants must be surgically sterile for at least 90 days prior to Screeningor agree not to donate sperm and, if engaging in sexual intercourse with a femalepartner who could become pregnant, must agree to use an acceptable method ofcontraception.
Exclusion
Exclusion Criteria:
History or presence of significant medical/surgical condition including any acuteillness or major surgery considered to be clinically significant or that couldimpact efficacy assessments.
Any coexisting conditions which may interfere with outcome assessments (eg, severediabetic neuropathy).
Concurrent or previous use of rituximab, cyclophosphamide, mycophenolate mofetil,azathioprine, or cyclosporine. If a participant has previously used thesemedications, the last dose must be at least 6 months prior to randomization.
Currently or previously on complement inhibitors including in a clinical trialsetting.
Prior history (at any time) of N. meningitidis infection.
Diagnosis of an autoimmune disorder other than MMN.
Positive test results for active human immunodeficiency virus (HIV-1 or HIV-2),hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibodies duringScreening.
History of active malignancy within 5 years prior to Screening, except basal cellcarcinoma of the skin, curatively resected squamous cell carcinoma of the skin,cervical carcinoma in situ curatively treated or low-grade prostate adenocarcinomafor which appropriate management is observation alone.
Participation in another clinical study of an investigational drug within 90 days or 5 half-lives of the investigational agent (whichever is longer) prior torandomization (Day 1).
Any other overlapping condition for which the condition or treatment of thecondition may affect the study assessments or outcomes.
Any other condition, including mental illness or prior therapy, that in the opinionof the Investigator would make the participant unsuitable for this study, includinginability to cooperate fully with the requirements of the study protocol orlikelihood of noncompliance with any study requirements.
Study Design
Connect with a study center
Clinical Study Site
Aarhus,
DenmarkSite Not Available
Clinical Study Site
Aarhus 2624652, 8200
DenmarkActive - Recruiting
Clinical Study Site
Copenhagen 2618425, 1172
DenmarkActive - Recruiting
Clinical Study Site
Marseille 2995469, 13005
FranceActive - Recruiting
Clinical Study Site
Paris 2988507, 94000
FranceActive - Recruiting
Clinical Study Site
Rome 3169070, 00189
ItalyActive - Recruiting
Clinical Study Site
Amsterdam 2759794, 1105
NetherlandsActive - Recruiting
Clinical Study Site
Utrecht 2745912,
NetherlandsActive - Recruiting
Clinical Study Site
Skopje 785842,
North MacedoniaActive - Recruiting
Clinical Study Site
Bydgoszcz, 85-090
PolandSite Not Available
Clinical Study Site
Bydgoszcz 3102014, 85-090
PolandActive - Recruiting
Clinical Study Site
Katowice, 40-689
PolandSite Not Available
Clinical Study Site
Katowice 3096472, 40-689
PolandActive - Recruiting
Clinical Study Site
Krakow 3094802, 30-688
PolandActive - Recruiting
Clinical Study Site
Belgrade 792680, 11000
SerbiaActive - Recruiting
Clinical Study Site
Barcelona 3128760, 08035
SpainActive - Recruiting
Clinical Study Site
London 2643743, England 6269131
United KingdomActive - Recruiting
Clinical Study Site
Oxford 2640729, England 6269131
United KingdomActive - Recruiting
Clinical Study Site
Scottsdale, Arizona 85251
United StatesSite Not Available
Clinical Study Site
Scottsdale 5313457, Arizona 5551752 85251
United StatesActive - Recruiting
Clinical Study Site
Los Angeles 5368361, California 5332921 90048
United StatesActive - Recruiting
Clinical Study Site
Bradenton, Florida 34205
United StatesSite Not Available
Clinical Study Site
Bradenton 4148708, Florida 4155751 34205
United StatesActive - Recruiting
Clinical Study Site
Tampa 4174757, Florida 4155751 33620
United StatesActive - Recruiting
Clinical Study Site
Honolulu 5856195, Hawaii 5855797 96817
United StatesActive - Recruiting
Clinical Study Site
Kansas City 4273837, Kansas 4273857 66103
United StatesActive - Recruiting
Clinical Study Site
Chapel Hill 4460162, North Carolina 4482348 27599
United StatesActive - Recruiting
Clinical Study Site
Cincinnati, Ohio 45219
United StatesSite Not Available
Clinical Study Site
Columbus, Ohio 43210
United StatesSite Not Available
Clinical Study Site
Cincinnati 4508722, Ohio 5165418 45219
United StatesActive - Recruiting
Clinical Study Site
Columbus 4509177, Ohio 5165418 43210
United StatesActive - Recruiting
Clinical Study Site
Houston, Texas 77030
United StatesSite Not Available
Clinical Study Site
Houston 4699066, Texas 4736286 77030
United StatesActive - Recruiting

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