Phase
Condition
N/ATreatment
Claseprubart
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 agree not to donate sperm and, if engaging in sexualintercourse with a female partner who could become pregnant, must agree to use anacceptable method of contraception or be surgically sterile for at least 90 daysprior to Screening.
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
Cinical Study Site
Toronto,
CanadaActive - Recruiting
Cinical Study Site
Beijing, 100053
ChinaActive - Recruiting
Clinical Study Site
Beijing, 100730
ChinaActive - Recruiting
Cinical Study Site
Shanghai, 200031
ChinaActive - Recruiting
Clinical Study Site
Aarhus, 8200
DenmarkActive - Recruiting
Clinical Study Site
Copenhagen, 1172
DenmarkActive - Recruiting
Clinical Study Site
Marseille, 13005
FranceActive - Recruiting
Clinical Study Site
Paris, 94000
FranceActive - Recruiting
Clinical Study Site
Rome, 00189
ItalyActive - Recruiting
Clinical Study Site
Kota Kinabalu, 88200
MalaysiaActive - Recruiting
Cinical Study Site
Kuala Lumpur, 50586
MalaysiaActive - Recruiting
Cinical Study Site
Permatang Pauh, 13700
MalaysiaActive - Recruiting
Cinical Study Site
Sarawak, 93586
MalaysiaActive - Recruiting
Clinical Study Site
Amsterdam, 1105
NetherlandsActive - Recruiting
Clinical Study Site
Utrecht,
NetherlandsActive - Recruiting
Clinical Study Site
Skopje,
North MacedoniaActive - Recruiting
Clinical Study Site
Bydgoszcz, 85-090
PolandActive - Recruiting
Clinical Study Site
Katowice, 40-689
PolandActive - Recruiting
Clinical Study Site
Krakow, 30-688
PolandActive - Recruiting
Clinical Study Site
Krakow 3094802, 31-202
PolandActive - Recruiting
Clinical Study Site
Belgrade, 11000
SerbiaActive - Recruiting
Cinical Study Site
Daegu,
South KoreaActive - Recruiting
Cinical Study Site #2
Seoul,
South KoreaActive - Recruiting
Clinical Study Site
Seoul,
South KoreaActive - Recruiting
Cinical Study Site
Alicante, 03010
SpainActive - Recruiting
Cinical Study Site
Barcelona, 08041
SpainActive - Recruiting
Clinical Study Site
Barcelona, 08035
SpainActive - Recruiting
Cinical Study Site
Istanbul, 34093
Turkey (Türkiye)Active - Recruiting
Clinical Study Site
London, England
United KingdomActive - Recruiting
Clinical Study Site
Oxford, England
United KingdomActive - Recruiting
Clinical Study Site
Salford, England
United KingdomActive - Recruiting
Clinical Study Site
Scottsdale, Arizona 85251
United StatesActive - Recruiting
Clinical Study Site
Los Angeles, California 90048
United StatesActive - Recruiting
Clinical Study Site
Bradenton, Florida 34205
United StatesActive - Recruiting
Clinical Study Site
Tampa, Florida 33620
United StatesActive - Recruiting
Clinical Study Site
Honolulu, Hawaii 96817
United StatesActive - Recruiting
Clinical Study Site
Kansas City, Kansas 66103
United StatesActive - Recruiting
Clinical Study Site
Cincinnati, Ohio 45219
United StatesActive - Recruiting
Clinical Study Site
Columbus, Ohio 43210
United StatesActive - Recruiting
Clinical Study Site
Houston, Texas 77030
United StatesActive - Recruiting

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