NIPH Clinical Trials Search

Phase III Clinical trial of NZ-C1909

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Degenerative lumbar diseases
Date of first enrollment	07/05/2026
Target sample size	300
Countries of recruitment
Study type	Interventional
Intervention(s)	The prepared investigational drug or autologous bone will be loaded into a spinal cage and inserted into a lumbar intervertebral disk space.

Outcome(s)

Primary Outcome

Bone fusion, as assessed using CT images at weeks 104

Secondary Outcome

1)Bone fusion, as assessed using CT images at weeks 26 and 52 2)Grade 1 bone fusion, as assessed using CT images at weeks 26, 52 and 104 3)Bone fusion, as assessed using X-ray images at weeks 26, 52 and 104 4)Changes from baseline in the scores on a visual analog scale for lower back or leg pain due to lumbar degenerative disease at weeks 6, 12, 26, 52, 78 and 104: Pain assessment scales 5)Changes in Oswestry Disability Index scores from baseline at weeks 6, 12, 26, 52, 78 and 104: Lumbar spine disease-specific functioning assessment 6)Changes in the scores on the JOA back pain evaluation questionnaire (JOABPEQ) at weeks 6, 12, 26, 52, 78 and 104: Lumbar spine disease-specific functioning assessment 7)Changes in EuroQol 5-Dimensions 5 Level (EQ-5D-5L) scores from baseline at weeks 6, 12, 26, 52, 78 and 104: Health-related QOL assessment

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include criteria	1)Lower back pain or leg pain due to lumbar degenerative disease for which intervertebral space lumbar interbody fusion is indicated 2)Fully matured skeleton at the time of surgery 3)Patients >=18 years of age at the time of consent 4)Patients who were fully informed of the details of this study and provided written informed consent
Exclude criteria	1)History of spinal fusion at the surgical site 2)Current or previous malignant tumor 3)Autoimmune diseases (such as systemic lupus erythematosus or rheumatoid arthritis) 4)Active systemic infection, infection at the intended surgical site, or significant risk factors, such as immunodeficiency 5)BMI >=30 6)History of smoking (including electronic cigarettes) within 12 weeks before the day of consent or inability to quit smoking during the study period 7)Diabetes mellitus with inadequate glycemic control (HbA1c >=7.0% at screening) 8)Undergoing dialysis 9)History of exposure to BMPs, whether human- or animal-derived, or known prior research use of another bone morphogenetic factor 10)History of hypersensitivity to a product containing nebotermin or rhBMP-2 11)Current and prior hypersensitivity to hydroxyapatite, beta-TCP, or protein derived from Escherichia coli 12)Contraindications for spinal instrumentation, including severe osteoporosis 13)Endocrine disorders (such as Graves' disease or Cushing syndrome) or metabolic disorders that affect bone metabolism 14)History of spinal surgery within 12 weeks before the first administration of the investigational drug 15)Treated with a drug that may affect bone fusion (such as teriparatide acetate, teriparatide, abaloparatide acetate, romosozumab, steroids [except for topical steroids and local injections], or immunosuppressants [except for topical immunosuppressants]) within 4 weeks before the first administration of the investigational drug 16)Pregnant or breastfeeding patients, female patients of childbearing potential, or male patients who are unable to practice appropriate contraception under the guidance of the investigator *A female patient of childbearing potential is defined as a patient who has experienced menarche, has not undergone contraceptive surgery (e.g., bilateral tubal ligation or total hysterectomy), and has not reached menopause (defined as having passed 52 weeks since the last menstrual period for which there are no other medical reasons) 17)Serious cardiac, renal, or hepatic disease (disease will be considered serious if it meets the criteria for Grade 3 disease specified in Notification No. 80 of the Safety Division, dated June 29, 1992, entitled "Seriousness grading criteria for adverse drug reactions") 18)Participation in another clinical study within 12 weeks before the first administration of the investigational drug or planning to participate in another study while participating in this one 19)Current or prior alcohol dependence, drug abuse, or narcotic addiction 20)Positive for HBs antigen, HCV antibody, or HIV antigen/antibody at screening 21)Any patient considered ineligible for participation in this study by the investigator