Discogenic PainPhase 2STA-02NCT04673461
Study Investigating STA363 Compared to Placebo in Patients With Chronic Discogenic Low Back Pain
A Phase 2 study testing STA363 containing 90 mg (60 mg/mL) lactic acid and STA363 containing 180 mg (120 mg/mL) lactic acid in people with Discogenic Pain, run by Stayble Therapeutics at 17 sites in 3 countries.
Trial summary
This is a phase IIb, prospective, multi-country, multicenter, randomized, double-blind, placebo-controlled, parallel group study to investigate the efficacy, safety and transformation of NP following single intradiscal injection of STA363 (lactic acid) into one or two IVDs compared to placebo for the treatment of… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Discogenic Pain
- What is being tested?
- STA363 containing 90 mg (60 mg/mL) lactic acid and STA363 containing 180 mg (120 mg/mL) lactic acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 17 sitesin 3 countries
- Study dates
- 31 Jul 2020to 31 Oct 2023
- Phase
- Phase 2
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent prior to any study related procedures.
- Male and female patients ≥18 and ≤70 years.
- Chronic discogenic low back pain present for more than 6 months prior to the screening visit.
- Insufficient response or lack of response to at least 6 months of non-operative treatment (analgesics and/or anti-inflammatory medications [paracetamol, non-steroidal anti-inflammatory agents (NSAIDs), opioids], physiotherapy, rehabilitation therapy etc.).
- Patients who meet all the following NRS selection criteria:
- Presence of ≥5 pain NRS assessments (entries) for 7 consecutive days.
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- NRS daily pain scores between 3-9.
- Not more than two ratings "3".
- One or two treatable IVDs of Pfirrmann grade 2 to 3 on MRI at L2/3 to L5/S1 as confirmed by a central reader, AND the following criteria are met:
- Treatable IVD(s) must be IVD(s) with the highest Pfirrmann grade observed in the patient (e.g. a patient with one IVD of grade 3 and four IVDs of grade 2 is considered eligible only if IVD of grade 3 will be injected).
- Patients with treatable IVD(s) of grade 2 must have all other lumbar discs rated as grade 1.
- Not more than two IVDs of grade 3 at any lumbar level.
- No IVDs of grade 4 or 5 at any lumbar level.
- Ability to understand the written and verbal information about the study.
Who cannot join
- Treatment with any investigational product within 3 months prior to the screening visit.
- Patients with more than two painful IVDs.
- A painful IVD above L2/3 level.
- Current infection or prior history of spinal infection (e.g., discitis, septic arthritis, epidural abscess) or an active systemic infection.
- Previous lumbar spine surgery.
- Previous disc invasive treatment procedures at the affected level(s) (e.g., intradiscal electrothermal therapy, intradiscal radiofrequency thermocoagulation).
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- Evidence of prior lumbar vertebral body fracture or trauma.
- Need for spinal decompression assessed by the Investigator.
- Presence of IVD extrusion or sequestration, or other radiologic findings that in the opinion of the investigator disqualify the patient from being included.
- Spondylolisthesis or retrolisthesis Grade 2 and above or spondylolysis at the index or adjacent level(s).
- Lumbar spondylitis or other undifferentiated spondyloarthropathy affecting the index IVD.
- Patients previously included in the study.
- Patients suffering from psychosomatic pain in the opinion of the Investigator.
- Leg pain of compressive origin.
- Patients requiring continuous treatment with warfarin or other anticoagulant therapy.
- History of significant neurologic or psychiatric disorders including dementia or seizures.
- Known alcohol and/or drug abuse.
- Severe intercurrent illness (e.g. rheumatic disease or chronic pain syndrome) or concomitant treatment (e.g. immunosuppressive drugs), which, in the opinion of the Investigator, may put the patient at risk when participating in the study, or affect the patient's ability to take part in the study.
- Pregnant or lactating females, or intention to become pregnant within the study period.
- Known allergy to any of the components of the drug product or placebo.
- Known allergy or intolerance to the contrast agent Omnipaque®.
- Known opioid allergy or intolerance.
- Any other condition that, in the opinion of the Investigator, precludes the patient from taking part in this study.
- Any specific contraindication for MRI such as claustrophobia, intracranial clips or pacemakers.
Trial locations and contacts
17 sites in 3 countries.
17 sites in 3 countries
Russia11 sites
Belgorod Regional Clinical Hospital of Saint Joasaph
Belgorod
Regional Clinical Hospital #3
Chelyabinsk
Kirov State Medical University
Kirov
Ochapovsky Regional Clinical Hospital #1
Krasnodar
Krasnoyarsk Interdistrict Clinical Emergency Hospital
Krasnoyarsk
Siberian Research Clinical Center
Krasnoyarsk
Privolzhsky Research Medical University
Nizhny Novgorod
Bekhterev Psychiatry and Neurology Center
Saint Petersburg
LLC MART
Saint Petersburg
Smolensk Regional Clinical Hospital
Smolensk
Tula Regional Clinical Hospital
Tula
Spain4 sites
Hospital Quirónsalud Córdoba
Córdoba
Complejo Hospitalario Ruber Juan Bravo
Madrid
Hm Puerta Del Sur
Móstoles
Hospital Universitario Quirónsalud Madrid
Pozuelo de Alarcón
Netherlands2 sites
Alrijne Ziekenhuis Leiderdorp
Leiderdorp
Rijnstate Hospital Anesthesiology and Pain
Velp
About this study
Official title: A Multi-country, Randomized, Double-blind, Placebo-controlled Study Investigating the Efficacy and Safety of STA363 at Two Concentrations (60 mg/mL and 120 mg/mL) Compared to Placebo in Patients With Chronic Discogenic Low Back Pain
This is a phase IIb, prospective, multi-country, multicenter, randomized, double-blind, placebo-controlled, parallel group study to investigate the efficacy, safety and transformation of NP following single intradiscal injection of STA363 (lactic acid) into one or two IVDs compared to placebo for the treatment of discogenic low back pain. This study will be conducted in Russia, Spain and the Netherlands.
Read the detailed description
This is a phase IIb, prospective, multi-country, multicenter, randomized, double-blind, placebo-controlled, parallel group study to investigate the efficacy, safety and transformation of NP following single intradiscal injection of STA363 (lactic acid) into one or two IVDs compared to placebo for the treatment of discogenic low back pain. This study will be conducted in Russia, Spain and the Netherlands.
The primary objective is to demonstrate superiority of STA363 over placebo in reducing low back pain as measured by the NRS. A total of 168 patients will be screened in the study with the aim to recruit 126 patients to be randomly allocated to one of the three treatment groups:
Group 1 - 42 patients will receive STA363 containing 90 mg (60 mg/mL) lactic acid Group 2 - 42 patients will receive STA363 containing 180 mg (120 mg/mL) lactic acid Group 3 - 42 patients will receive placebo
The investigational medical product (IMP) will be injected into the center of up to two IVDs. Patients with two discs appropriate for treatment will be treated at both affected levels by two separate injections.
Each patient will have 5 visits to study site and 1 telephone call. The patient's total time in the study will be approximately 61 weeks (~15 months) including an 8-week screening period.
Each patient will perform a screening visit (Visit 1) maximum 60 days before planned treatment. Randomization and treatment will be performed at Visit 2 (Day 1) after confirmation of patient's eligibility for the study. The IMP will be administered, monitored by fluoroscopy or other available method of real-time x-ray imaging to ensure that an injection is correctly placed in the IVD nucleus and that no leakage occurs. Immediately after treatment the patients should remain supine for as long as possible (at least 1 hour). For safety reasons, patients will be allowed to leave the clinic not earlier than 2 hours after the last injection. After leaving the clinic, patients will be offered analgesics and/or other measures according to standard clinical practice. They will also be given advice on restricted physical activity during the first two weeks after injection. Patients should not drive or operate machinery for 12 hours following the treatment procedure.
Patients will be followed up at 1 month (Visit 3/Day 30±7, visit to study site), 3 months (Visit 4/Day 90±7, telephone call), 6 months (Visit 5/Day 180±7, visit to study site) and 12 months (Visit 6/Day 360±7, visit to study site) after treatment. Follow-up MRI will be conducted as part of Visit 5 and Visit 6, to assess the transformation of the NP into connective tissue and other disc characteristics.
- Conditions
- Discogenic Pain
- Being tested
- STA363 containing 90 mg (60 mg/mL) lactic acid, STA363 containing 180 mg (120 mg/mL) lactic acid, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STA363 containing 90 mg (60 mg/mL) lactic acidDrug
STA363 (90 mg) will be injected into maximally two pain-generating degenerated intervertebral discs
STA363 containing 180 mg (120 mg/mL) lactic acidDrug
STA363 (180 mg) will be injected into maximally two pain-generating degenerated intervertebral discs
PlaceboDrug
Placebo will be injected into maximally two pain-generating degenerated intervertebral discs
| Study group | Role | What they receive |
|---|---|---|
| STA363 containing 90 mg (60 mg/mL) lactic acid | Experimental | STA363 containing 90 mg (60 mg/mL) lactic acid will be injected into the center of up to two intervertebral discs. Patients with two discs appropriate for treatment will be treated at both affected levels by two separate injections.
Each patient will have 5 visits to study site and 1 telephone call. The patient's total time in the study will be approximately 61 weeks (~15 months) including an 8-week screening period. Receives: Drug: STA363 containing 90 mg (60 mg/mL) lactic acid |
| STA363 containing 180 mg (120 mg/mL) lactic acid | Experimental | STA363 containing 180 mg (120 mg/mL) lactic acid will be injected into the center of up to two intervertebral discs. Patients with two discs appropriate for treatment will be treated at both affected levels by two separate injections.
Each patient will have 5 visits to study site and 1 telephone call. The patient's total time in the study will be approximately 61 weeks (~15 months) including an 8-week screening period. Receives: Drug: STA363 containing 180 mg (120 mg/mL) lactic acid |
| Placebo | Placebo comparator | Placebo will be injected into the center of up to two intervertebral discs. Patients with two discs appropriate for treatment will be treated at both affected levels by two separate injections.
Each patient will have 5 visits to study site and 1 telephone call. The patient's total time in the study will be approximately 61 weeks (~15 months) including an 8-week screening period. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity at 6 months on a Numerical rating scale
Change from baseline at Month 6 in mean pain intensity measured on a Numerical rating scale (minimum value: 0; maximum value: 10) for 7 consecutive days. Lower scores means a better outcome.
Measured: 6 months
Secondary outcomes (4)
Pain intensity at Month 1, Month 3 and Month 12 on a Numerical rating scale
Change from baseline at Month 1, 3 and 12 in mean pain intensity measured on a Numerical rating scale (minimum value: 0; maximum value: 10) for 7 consecutive days. Lower scores means a better outcome.
Measured: 1 month, 3 months and 12 months
Oswestry Disability Index
Change from baseline in Oswestry Disability Index score (minimal-maximal values: 0-100 where a lower number means better outcome) at Month 1, Month 3, Month 6 and Month 12. Lower scores means a better outcome.
Measured: 1 month, 3 months, 6 months and 12 months
EuroQoL 5-dimension 5-level
Change from baseline in EuroQoL 5-dimension 5-level-index at Month 1, Month 3, Month 6 and Month 12. Higher scores means a better outcome.
Measured: 1 month, 3 months, 6 months and 12 months
Nucleus pulposus transformation
Quantitative changes in nucleus pulposus (NP) water content (reflecting transformation of NP into connective tissue) at Month 6 and Month 12 (T2-weighted magnetic resonance imaging [MRI] and quantification of T2). Lower scores means a better outcome.
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start31 Jul 2020
- Primary completion1 Sep 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Discogenic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three treatment groups: * STA363 60 mg/mL * STA363 120 mg/mL * Placebo
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stayble Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jan Willem Kallewaard, MD, PhD, Principal investigator, Rijnstate Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04673461
- Sponsor's protocol ID
- STA-02
- Other IDs
- 2019-004943-54, 2019
- Acronym
- STA-02
- Status last verified
- Dec 2025
- First submitted
- 1 Dec 2020
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-country, Randomized, Double-blind, Placebo-controlled Study Investigating the Efficacy and Safety of STA363 at Two Concentrations (60 mg/mL and 120 mg/mL) Compared to Placebo in Patients With Chronic Discogenic Low Back Pain
- ClinicalTrials.gov ID
- NCT04673461
- Acronym / sponsor ID
- STA-02 / STA-02
- Conditions
- Discogenic Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Stayble TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 31 Jul 2020 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 17 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase IIb, prospective, multi-country, multicenter, randomized, double-blind, placebo-controlled, parallel group study to investigate the efficacy, safety and transformation of NP following single intradiscal injection of STA363 (lactic acid) into one or two IVDs compared to placebo for the treatment of discogenic low back pain. This study will be conducted in Russia, Spain and the Netherlands.
Detailed description
This is a phase IIb, prospective, multi-country, multicenter, randomized, double-blind, placebo-controlled, parallel group study to investigate the efficacy, safety and transformation of NP following single intradiscal injection of STA363 (lactic acid) into one or two IVDs compared to placebo for the treatment of discogenic low back pain. This study will be conducted in Russia, Spain and the Netherlands.
The primary objective is to demonstrate superiority of STA363 over placebo in reducing low back pain as measured by the NRS. A total of 168 patients will be screened in the study with the aim to recruit 126 patients to be randomly allocated to one of the three treatment groups:
Group 1 - 42 patients will receive STA363 containing 90 mg (60 mg/mL) lactic acid Group 2 - 42 patients will receive STA363 containing 180 mg (120 mg/mL) lactic acid Group 3 - 42 patients will receive placebo
The investigational medical product (IMP) will be injected into the center of up to two IVDs. Patients with two discs appropriate for treatment will be treated at both affected levels by two separate injections.
Each patient will have 5 visits to study site and 1 telephone call. The patient's total time in the study will be approximately 61 weeks (~15 months) including an 8-week screening period.
Each patient will perform a screening visit (Visit 1) maximum 60 days before planned treatment. Randomization and treatment will be performed at Visit 2 (Day 1) after confirmation of patient's eligibility for the study. The IMP will be administered, monitored by fluoroscopy or other available method of real-time x-ray imaging to ensure that an injection is correctly placed in the IVD nucleus and that no leakage occurs. Immediately after treatment the patients should remain supine for as long as possible (at least 1 hour). For safety reasons, patients will be allowed to leave the clinic not earlier than 2 hours after the last injection. After leaving the clinic, patients will be offered analgesics and/or other measures according to standard clinical practice. They will also be given advice on restricted physical activity during the first two weeks after injection. Patients should not drive or operate machinery for 12 hours following the treatment procedure.
Patients will be followed up at 1 month (Visit 3/Day 30±7, visit to study site), 3 months (Visit 4/Day 90±7, telephone call), 6 months (Visit 5/Day 180±7, visit to study site) and 12 months (Visit 6/Day 360±7, visit to study site) after treatment. Follow-up MRI will be conducted as part of Visit 5 and Visit 6, to assess the transformation of the NP into connective tissue and other disc characteristics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Three treatment groups: * STA363 60 mg/mL * STA363 120 mg/mL * Placebo
| Arm | Type | Receives |
|---|---|---|
| STA363 containing 90 mg (60 mg/mL) lactic acid | Experimental | Drug: STA363 containing 90 mg (60 mg/mL) lactic acidSTA363 containing 90 mg (60 mg/mL) lactic acid will be injected into the center of up to two intervertebral discs. Patients with two discs appropriate for treatment will be treated at both affected levels by two separate injections. Each patient will have 5 visits to study site and 1 telephone call. The patient's total time in the study will be approximately 61 weeks (~15 months) including an 8-week screening period. |
| STA363 containing 180 mg (120 mg/mL) lactic acid | Experimental | Drug: STA363 containing 180 mg (120 mg/mL) lactic acidSTA363 containing 180 mg (120 mg/mL) lactic acid will be injected into the center of up to two intervertebral discs. Patients with two discs appropriate for treatment will be treated at both affected levels by two separate injections. Each patient will have 5 visits to study site and 1 telephone call. The patient's total time in the study will be approximately 61 weeks (~15 months) including an 8-week screening period. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo will be injected into the center of up to two intervertebral discs. Patients with two discs appropriate for treatment will be treated at both affected levels by two separate injections. Each patient will have 5 visits to study site and 1 telephone call. The patient's total time in the study will be approximately 61 weeks (~15 months) including an 8-week screening period. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Signed informed consent prior to any study related procedures.
- Male and female patients ≥18 and ≤70 years.
- Chronic discogenic low back pain present for more than 6 months prior to the screening visit.
- Insufficient response or lack of response to at least 6 months of non-operative treatment (analgesics and/or anti-inflammatory medications [paracetamol, non-steroidal anti-inflammatory agents (NSAIDs), opioids], physiotherapy, rehabilitation therapy etc.).
- Patients who meet all the following NRS selection criteria:
Key exclusion criteria (24 listed)
- Treatment with any investigational product within 3 months prior to the screening visit.
- Patients with more than two painful IVDs.
- A painful IVD above L2/3 level.
- Current infection or prior history of spinal infection (e.g., discitis, septic arthritis, epidural abscess) or an active systemic infection.
- Previous lumbar spine surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STA363 containing 90 mg (60 mg/mL) lactic acidSTA363 (90 mg) will be injected into maximally two pain-generating degenerated intervertebral discs | Drug | STA363 containing 90 mg (60 mg/mL) lactic acid |
| STA363 containing 180 mg (120 mg/mL) lactic acidSTA363 (180 mg) will be injected into maximally two pain-generating degenerated intervertebral discs | Drug | STA363 containing 180 mg (120 mg/mL) lactic acid |
| PlaceboPlacebo will be injected into maximally two pain-generating degenerated intervertebral discs | Drug | Placebo |
Primary outcome
Pain intensity at 6 months on a Numerical rating scale
Time frame: 6 months
Change from baseline at Month 6 in mean pain intensity measured on a Numerical rating scale (minimum value: 0; maximum value: 10) for 7 consecutive days. Lower scores means a better outcome.
4 secondary outcomes
Pain intensity at Month 1, Month 3 and Month 12 on a Numerical rating scale
Time frame: 1 month, 3 months and 12 months
Oswestry Disability Index
Time frame: 1 month, 3 months, 6 months and 12 months
EuroQoL 5-dimension 5-level
Time frame: 1 month, 3 months, 6 months and 12 months
Nucleus pulposus transformation
Time frame: 6 and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Willem Kallewaard, MD, PhD principal investigator
Rijnstate Hospital
17 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing STA363 containing 90 mg (60 mg/mL) lactic acid and STA363 containing 180 mg (120 mg/mL) lactic acid in people with Discogenic Pain, run by Stayble Therapeutics at 17 sites in 3 countries.
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 14 inclusion and 24 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: finished, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Russia, Spain, Netherlands. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pain intensity at 6 months on a Numerical rating scale (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Dec 2025.