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

• Status: Completed
• Trial end date: 2019-07-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck KGaA; Merck KGaA, Darmstadt, Germany

Criteria

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