Multiple Ascending Doses (MAD) of Anti-A Disintegrin and Metalloproteinase With Thrombospondin Motifs-5 (Anti-ADAMTS-5) Nanobody in Participants With Knee Osteoarthritis (OA)

Merck KGaA (EMD Serono)

Status and phase

Completed

Phase 1

Conditions

Osteoarthritis, Knee

Treatments

Drug: M6495

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT03583346

MS200572_0003

2018-000797-29 (EudraCT Number)

Details and patient eligibility

About

The study will be conducted in participants with symptomatic knee OA to explore the safety, tolerability, immunogenicity, pharmacokinetics (PK), and pharmacodynamics (PD) of MAD of M6495.

Enrollment

32 patients

Sex

All

Ages

40 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Kellgren Lawrence (KL) radiological Grade of 2 to 4 in the target knee
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscore of greater than or equal to (>=) 40 out of 100 in the target knee at screening
Primary or post-traumatic femorotibial OA according to American College of Rheumatology clinical and radiographic criteria
Have completed at least 4 days of the participant 7-day diary in the period from Day -8 to Day 1
Can give signed informed consent
Other protocol defined inclusion criteria could apply

Exclusion criteria

History of arthroscopy or intra-articular administration of corticosteroids or hyaluronic acid into the target knee within 6 months before screening
Intention of having major knee surgeries or total knee replacement during the time frame of this study in either knee
Secondary OA in target knee joint because of joint dysplasia, aseptic osteonecrosis, acromegaly, Paget disease, Stickler syndrome, hemochromatosis, gout, chondrocalcinosis, or calcium pyrophosphate deposition disease
Any known active systemic infection, including infection that might compromise the immune system such as human immunodeficiency virus, or hepatitis B or C
History of myocardial infarction or cerebrovascular event within 6 months prior to screening, or current active angina pectoris, symptomatic heart failure, seizures, untreated hypertension, gastrointestinal bleeding, or any other significant medical condition in the Investigator's opinion
History of cancer, except adequately treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ/cervical intraepithelial neoplasia of the uterine cervix, unless considered cured >= 5 years
Other protocol defined exclusion criteria could apply