Clinical Trial of YH14618 in Patients With Degenerative Disc Disease

NCT02320019 | Completed Phase 2

• 1 other identifier: YH14618-202
• Study Type: interventional
• Target: 326
• Locations: 1 country
• Sites: 1

Brief Summary

Research Hypothesis: There will be a greater proportion of VAS responders defined as those who achieve ≥ 50% reduction from baseline in VAS for low back pain at week 12 following intradiscal injection of YH14618 compared to placebo. Patients have been diagnosed as one or two symptomatic lumbar degenerative disc disease defined as Pfirrmann grade 2 to 4 using MRI. Patients have suffered from persistent low back pain with at least 3 months of conservative therapy and must have low back pain measured by VAS≥4 cm and modified Oswestry disability index (mODI) ≥30% at the baseline.

Conditions

Disc Degenerative Disease

Outcome Measures

Primary Outcomes (1)

• Proportion of VAS responders

  Proportion of VAS responders defined as those who achieve ≥ 50% reduction in VAS at week 12 from baseline

  at 12-week

Secondary Outcomes (4)

• Proportion of VAS responders

  at 24-week

• Proportion of mODI responder

  at 12-week, 24-week

• Changes in VAS score from baseline

  Each visit for 24 weeks

• Changes in mODI score from baseline

  Each visit for 24 weeks

Other Outcomes (17)

• Proportion of moderate VAS responder

  at 12-week, 24-week

• Percent change from baseline to Week 12 and 24 for VAS

  Each visit between Week 12 and 24

• Proportion of patients who are being VAS responders at Week 12 and maintain the treatment effect of ≥ 50% reduction in VAS up to week 16, 20, and 24

  Each visit between Week 12 and 24

Study Arms (5)

Placebo group

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Group A

EXPERIMENTAL

YH14618 A mg/disc

Drug: YH14618

Group B

EXPERIMENTAL

YH14618 B mg/disc

Drug: YH14618

Group C

EXPERIMENTAL

YH14618 C mg/disc

Drug: YH14618

Group D

EXPERIMENTAL

YH14618 D mg/disc

Drug: YH14618

Interventions

Placebo DRUG

Placebo matching YH14618

Placebo group

YH14618 DRUG

Group A; Group B; Group C; Group D

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed as one or two symptomatic early lumbar (L1/L2 \~ L5/S1) degenerative disc disease defined as Pfirrmann grade 2 to 4 using MRI performed within 4 weeks prior to randomization.
• Patients have suffered from persistent low back pain with at least 3-month conservative therapy.
• Patients have low back pain measured by VAS≥4cm and mODI≥30% at screening and randomization visit (Day 0).

You may not qualify if:

• Clinically significant spine compression fracture, spinal stenosis, or spinal instability.
• Clinically significant sacroiliac joint dysfunction, facet joint pain, or those who are suspected.
• Modic change type III assessed by X-ray and MRI
• History of spine surgery
• Neurologic disorders.
• Any other systemic disease which can influence spine such as rheumatoid arthritis, ankylosing spondylitis, or autoimmune disease.
• Participation in other clinical trials with intradiscal injection (eg, Phase 1/2a YH14618-201 trial, or Cell therapy, etc.)

Sponsors & Collaborators

• Yuhan Corporation: lead

Study Sites (1)

Severance Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Su Youn Nam, M.D., Ph.D.

  Yuhan Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2014
• First Posted: December 19, 2014
• Study Start: March 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: August 1, 2016
• Last Updated: November 10, 2016

Record last verified: 2016-11

Locations

KR (1)