AzTrials
AzTrials

Degenerative Disc DiseasePhase 1NCT03246399

A Study of the Safety, Tolerability, and Pharmacokinetics of SM04690 Injectable Suspension Following Single Intradiscal Injection in Subjects With Degenerative Disc Disease

A Phase 1 study testing SM04690 in people with Degenerative Disc Disease, run by Biosplice Therapeutics, Inc. at 4 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

SM04690-DDD-01 is a Phase 1, open-label, dose escalation study. SM04690 Injectable Suspension will be administered via a single intradiscal injection to subjects with degenerative disc disease (DDD) under fluoroscopic guidance. Groups of 6 subjects will be enrolled in successive cohorts. Read more about this study

Who is it for?
Ages 25 to 55 years
Conditions the study is for
Degenerative Disc Disease
What is being tested?
SM04690
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
4 sitesUnited States
Study dates
26 Jul 2017to 4 Dec 2018
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Degenerative disease in a maximum of two and a minimum of one lumbar disc (L4/L5 or L5/S1)
  • Persistent low back pain due to DDD for at least 3 months prior to study start
  • Full understanding of the requirements of the study and willingness to comply with all study visits and assessments
  • Subjects must have read and understood the informed consent form, and must have signed it prior to any study-related procedure being performed

Who cannot join

  • Women who are pregnant, lactating, or have a positive pregnancy result at study start
  • Women of child bearing potential who are sexually active and are not willing to use a highly effective method of birth control during the study period
  • Males who are sexually active and have a partner who is capable of becoming pregnant, neither of whom have had surgery to become sterilized or whom are not using a highly effective method of birth control
  • Body mass index (BMI) > 35
  • Previous participation in a Samumed clinical trial investigating SM04690
  • History of compression fractures and/or osteoporosis
Show all 23Show fewer
  • Any herniation in the lumbar spine as identified by MRI
  • Congenital or acquired diseases leading to spine deformations
  • History of hypersensitivity or allergies to any ingredient of the study medication
  • Participation in a clinical research trial that included the receipt of an investigational product or any experimental therapeutic procedure, or an observational research trial related to DDD within 8 weeks prior to any study injection, or planned participation in any such trial; the last date of participation in the trial, not the last date of receipt of investigational product, must be at least 8 weeks prior to study start
  • Poor peripheral venous access
  • Any contraindications to MRI according to MRI guidelines
  • History of malignancy; however, subjects with prior history of in situ cancer or basal or squamous cell skin cancer, completely cured, are eligible.
  • Any diagnosed psychiatric condition that includes, but is not limited to, a history of mania, bipolar disorder, psychotic disorder, schizophrenia, schizoaffective disorder, major depressive disorder, or generalized anxiety disorder
  • Prior surgical procedures (e.g., discectomy, intradiscal electrothermal therapy, intradiscal radiofrequency, artificial disc replacement, and interbody fusion) on the lumbar spine
  • Any planned or elective surgery during the study period
  • Any known active infections, including hepatitis B or hepatitis C infection, and/or infections that may compromise the immune system such as human immunodeficiency virus (HIV)
  • Current or prior history of any spinal infection (i.e., discitis, septic arthritis, or epidural abscess)
  • Any lumbar intradiscal injection procedure (e.g., injection of corticosteroids, methylene blue, dextrose, etc.), myelograms, discography, and/or lumbar epidural or transforaminal injections with corticosteroids or nerve-blocking anesthetics (e.g, lidocaine, bupivacaine) within 3 months prior to study start
  • Any electrotherapy (i.e., transcutaneous electrical nerve stimulation [TENS] unit) or acupuncture for DDD within 4 weeks prior to study medication injection
  • History of or current/pending disability claim, workers' compensation, or litigation(s) related to back pain/injury
  • Subjects who are immediate family members (spouse, parent, child, or sibling; biological or legally adopted) of personnel directly affiliated with the study at any investigative site, or are directly affiliated with the study at any investigative site
  • Subjects employed by Samumed, LLC, or any of its affiliates or development partners (that is, an employee, temporary contract worker, or designee) responsible for the conduct of the study, or who are immediate family members (spouse, parent, child, or sibling; biological or legally adopted) of said employees responsible for the conduct of the study

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Research Site

    Charleston, South Carolina, 29406

  • Research Site

    Richmond, Virginia, 23235

  • Research Site

    San Diego, California, 92103

  • Research Site

    Tyler, Texas, 75701

Other trials in United States

About this study

Official title: A Phase 1, Open-label Study of the Safety, Tolerability, and Pharmacokinetics of SM04690 Injectable Suspension Following Single Intradiscal Injection in Subjects With Degenerative Disc Disease

SM04690-DDD-01 is a Phase 1, open-label, dose escalation study. SM04690 Injectable Suspension will be administered via a single intradiscal injection to subjects with degenerative disc disease (DDD) under fluoroscopic guidance. Groups of 6 subjects will be enrolled in successive cohorts. Subjects will participate in a 6 month follow-up period. Clinic visits will be Screening, Treatment Visit Day 1, and Follow-up Visit Days 2, 15, 28, 60, 90, 135, and 180.

Being tested
SM04690
Keywords
SM04690, Wnt pathway, Samumed
Medical subject headings
Intervertebral Disc Degeneration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SM04690Drug

    suspension formulation of SM04690, delivered via intradiscal injection (single injection)

Study groups in NCT03246399
Study groupRoleWhat they receive
0.03mg SM04690Experimental0.03mg SM04690 per 0.5 mL intradiscal injection (single injection at Day 1)
Receives: Drug: SM04690
0.07mg SM04690Experimental0.07mg SM04690 per 0.5 mL intradiscal injection (single injection at Day 1)
Receives: Drug: SM04690
0.15mg SM04690Experimental0.15mg SM04690 per 0.5 mL intradiscal injection (single injection at Day 1)
Receives: Drug: SM04690

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety and tolerability: treatment emergent adverse events (TEAEs)

    Evaluate the safety and tolerability of SM04690 Injectable Suspension as measured by TEAEs during the entire treatment and observation period

    Measured: Day 180

  2. Safety and tolerability: change from baseline in electrocardiogram (ECG) parameters

    Evaluate the safety and tolerability of SM04690 Injectable Suspension as measured by change from baseline in ECG parameters

    Measured: Baseline and Day 180

  3. Safety and tolerability: change from baseline in physical examination

    Evaluate the safety and tolerability of SM04690 Injectable Suspension as measured by change from baseline in physical examination (number of subjects with clinically significant change in physical examination)

    Measured: Baseline and Day 180

  4. Safety and tolerability: change from baseline in clinical laboratory tests

    Evaluate the safety and tolerability of SM04690 Injectable Suspension as measured by change from baseline in clinical laboratory tests (number of subjects with clinically significant changes in laboratory test parameters)

    Measured: Baseline and Day 180

  5. Safety and tolerability: change from baseline in vital signs

    Evaluate the safety and tolerability of SM04690 Injectable Suspension as measured by change from baseline in vital signs (number of subjects with clinically significant changes in vital signs)

    Measured: Baseline and Day 180

  6. Incidence of dose-limiting toxicities (DLTs)

    Evaluate incidence and severity of DLTs in each cohort

    Measured: Day 180

  7. Pharmacokinetics (PK) of SM04690: Cmax

    Maximum plasma concentration (Cmax) estimate for a single intradiscal injection of SM04690 Injectable Suspension

    Measured: Day 1

  8. PK of SM04690: tmax

    Time to Cmax estimate for a single intradiscal injection of SM04690 Injectable Suspension

    Measured: Day 1

  9. PK of SM04690: AUC

    Area under the plasma-concentration time curve (AUC) estimate for a single intradiscal injection of SM04690 Injectable Suspension

    Measured: Day 1

  10. PK of SM04690: half-life

    Plasma terminal phase half-life estimate for a single intradiscal injection of SM04690 Injectable Suspension

    Measured: Day 1

Secondary outcomes (2)

  1. Change in spine bone mineral density

    Evaluate change from baseline spine bone mineral density as measured by dual-energy x-ray absorptiometry (DXA)

    Measured: Baseline and Day 180

  2. Change in hip bone mineral density

    Evaluate change from baseline hip bone mineral density as measured by DXA

    Measured: Baseline and Day 180

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Aug 2017
  2. Study start26 Jul 2017
  3. Primary completion14 Nov 2018
  4. Study completion4 Dec 2018

Why it stopped: Study stopped due to business reasons, following full enrollment of the first dose cohort.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03246399
Sponsor's protocol ID
SM04690-DDD-01
Status last verified
Apr 2019
First submitted
29 Jun 2017
Last updated
23 Apr 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SM04690 in people with Degenerative Disc Disease, run by Biosplice Therapeutics, Inc. at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 23 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Study stopped due to business reasons, following full enrollment of the first dose cohort.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and tolerability: treatment emergent adverse events (TEAEs) (time frame: Day 180). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03246399.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in