Lumbosacral Radicular PainPhase 3CLEAR 2NCT07579351
Corticosteroid Lumbar Epidural Analgesia for Radicular Pain 2
A Phase 3 study testing SP-102 and Dexamethasone Sodium Phosphate 10 MG/ML in people with Lumbosacral Radicular Pain, run by Semnur Pharmaceuticals, Inc..
Trial summary
This is a research study of SP-102, an experimental medication designed to relieve pain in patients with moderate to severe sciatica (pain in the lower back, hips, buttocks and legs). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lumbosacral Radicular Pain
- What is being tested?
- SP-102 and Dexamethasone Sodium Phosphate 10 MG/ML
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 755 participants
- Where
- No sites listed yet
- Study dates
- Feb 2027to Apr 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Main Inclusion Criteria:
- Able and willing to read, write, and understand the English language and provide English language written informed consent prior to beginning any study procedures.
- Age 18 to 75 years (inclusive) at the Screening Visit.
- A diagnosis of lumbosacral radicular pain (sciatica) present for at least 6 weeks and not more than 9 months prior to the Screening Visit.
- Clinical symptoms consistent with the imaging (MRI)
- Agrees to follow study-specific medication requirements.
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- If sexually active and a female of child-bearing potential or a male capable of bearing a child, agrees to use an effective method of birth control during the study.
- Has reviewed all study specific materials and has, in the opinion of the Investigator, the abilities to understand and appropriately complete all study procedures.
- Day 1 Inclusion:
- As calculated by the eDiary system, during the 7 days (D-7 to D-1) immediately prior to the Baseline Visit, the participant:
- Completed the current, worst, and daily average NPRS scores (in the affected leg, non-affected leg, and lower back) in the eDiary on at least 6 out of the 7 days during the Baseline Period.
- Meets the NPRS average daily pain score criteria,
- Has a mean (at Baseline Visit) NPRS worst pain score in the affected leg that is greater than the mean worst pain score in lower back.
- Participant continues to demonstrate a clear understanding of how to complete the eDiary.
- Participant remains an appropriate candidate for trial participation in the opinion of the Investigator.
- Participant continues to meet all the screening inclusion criteria and none of the exclusion criteria. -
Who cannot join
- Has a body mass index ≥40 kg/m2.
- Has radiologic evidence of a condition that would compromise study outcomes:
- Spinal cord tumor (intra- or extradural) or hematoma. Epidural or intrathecal abscess. Systemic infection.
- Has ever had lumbosacral back surgery or plans to undergo spine surgical intervention while in the study.
- Has been diagnosed with insulin dependent diabetes mellitus.
- Presence of any other disorder, condition or circumstance (including secondary gain) that, in the opinion of the Investigator, has the potential to prevent study completion and/or to have a confounding effect on outcome assessments.
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- Use of any investigational drug and/or device within 30 days, or is scheduled to receive an investigational drug other than blinded study drug during this study.
- Has any contradiction to performing MRI (such as coronary pacemakers and implantable cardioverter-defibrillators [ICDs], metallic foreign bodies, neuro and spinal cord stimulators).
- Has history of malignancy or evidence of malignancy, within 5 years of Screening Visit.
- Has significant motor impairment
- Has regular use of opioid doses > 30 mg morphine equivalents per day for more than 2 days per week in the 30 days prior to the Screening Visit.
- Involvement in an ongoing worker's compensation claim, disability claim, or litigation related to any pain problem, receiving payments for a settled claim, awaiting pending payment for a settled claim, or any potential secondary gain in the opinion of the Investigator.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Dmitri Lissin, Study Director, MD contact
About this study
Official title: Corticosteroid Lumbar Epidural Analgesia for Radicular Pain (C.L.E.A.R) 2 - A Randomized, Double-blind, Active Comparator and Placebo-controlled, Multicenter, Safety and Efficacy Trial of SP-102
This is a research study of SP-102, an experimental medication designed to relieve pain in patients with moderate to severe sciatica (pain in the lower back, hips, buttocks and legs). SP-102, placebo (a medication that looks like SP-102 but does not contain any active ingredient), or an active comparator (dexamethasone sodium phosphate) is given once by the participant's healthcare professional. If a participant meets qualifications, each participant will have the option of receiving one supplemental open-label injection of SP-102, greater than four weeks and up to twenty weeks after their first injection.
The purpose of the study is to measure how well a single injection of the experimental medication, SP-102, relieves pain versus placebo. The study will also measure how well SP-102 relieves pain versus an active comparator medication (dexamethasone sodium phosphate). The study will also investigate the side effects of SP-102.
Read the detailed description
This is a double-blind, randomized, active comparator (dexamethasone sodium phosphate) and placebo-controlled, multicenter trial in participants with moderate-to-severe lumbosacral radicular pain evaluating the safety and efficacy of a single SP-102 TF injection compared to a single placebo IM injection or a single dexamethasone sodium phosphate TF injection (active comparator), followed by an open-label safety extension, evaluating an optional SP-102 TF injection, if indicated and qualified for, administered once between > 4 to 20 weeks later.
- Conditions
- Lumbosacral Radicular Pain
- Being tested
- SP-102, Placebo, Dexamethasone Sodium Phosphate 10 MG/ML
- Keywords
- Lumbosacral Radicular Pain, Sciatica, Leg Pain
- Medical subject headings
- Sciatica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SP-102Drug
One Injection
PlaceboDrug
One injection
Dexamethasone Sodium Phosphate 10 MG/MLDrug
One injection
| Study group | Role | What they receive |
|---|---|---|
| SP-102 | Experimental | Not described Receives: Drug: SP-102 |
| Placebo Comparator | Placebo comparator | Not described Receives: Drug: Placebo |
| dexamethasone sodium phosphate | Active comparator | Not described Receives: Drug: Dexamethasone Sodium Phosphate 10 MG/ML |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from baseline to W4 in the mean NPRS average daily pain score.
The Numeric Pain Rating Scale (NPRS) is a self-reported scale assessing average pain intensity over the past 24 hours in the affected leg. Possible scores range from 0-10 (0 is no pain, 10 is worst pain imaginable) Change from baseline (mean of the scores recorded on the 7 days [D-7 to D-1] immediately prior to the P1 Injection Day) in mean NPRS average daily pain score in the affected leg over 4 weeks (i.e., W1, W2, W3, W4) for SP-102 versus placebo.
Measured: Day 1 to week 4
Secondary outcomes (5)
Mean change in ODI total score
The Oswestry disability index (ODI) is a validated, self-reported instrument that evaluates degree of disability (0-100, 0=No disability, 100=Maximum disability).
Comparison is between SP-102 and placebo.
Measured: Day 1 to Week 4
Patient Global Impression of Change
The PGIC scores range from 1 (very much improved) through 7 (very much worse) as assessed by the participant.
Measured: Day 1 to week 4
Mean change in BPI-Pain Interference (BPI-PI) score from P1 Baseline (D1) to P1 W4 for SP-102 versus placebo.
Participants rate their worst, least, average, and current pain intensity on a 0-10 numeric rating scale as it affects their daily functioning (0=does not interfere and 10=completely interferes).
Measured: Day 1 to week 4
Proportion of participants with a ≥ 30% improvement from P1 D1 to W4 in mean NPRS average daily pain score in the affected leg for SP-102 versus placebo.
The Numeric Pain Rating Scale (NPRS) is a self-reported scale assessing average pain intensity over the past 24 hours in the affected leg. Possible scores range from 0-10 (0 is no pain, 10 is worst pain imaginable) Change from baseline (mean of the scores recorded on the 7 days [D-7 to D-1] immediately prior to the P1 Injection Day) in mean NPRS average daily pain score in the affected leg over 4 weeks (i.e., W1, W2, W3, W4) for SP-102 versus placebo.
Measured: Day 1 to week 4
Proportion of participants with a ≥ 50% improvement from P1 D1 to W4 in mean NPRS average daily pain score in the affected leg for SP-102 versus placebo.
The Numeric Pain Rating Scale (NPRS) is a self-reported scale assessing average pain intensity over the past 24 hours in the affected leg. Possible scores range from 0-10 (0 is no pain, 10 is worst pain imaginable) Change from baseline (mean of the scores recorded on the 7 days [D-7 to D-1] immediately prior to the P1 Injection Day) in mean NPRS average daily pain score in the affected leg over 4 weeks (i.e., W1, W2, W3, W4) for SP-102 versus placebo.
Measured: Day 1 to week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study startFeb 2027 (estimated)
- Primary completionNov 2028 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbosacral Radicular 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, Double-blind, Active Comparator and Placebo-controlled, Multicenter, Safety and Efficacy
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 755 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Semnur Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Syngene, Cromos Pharma LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07579351
- Sponsor's protocol ID
- SP-102-05
- Acronym
- CLEAR 2
- Status last verified
- Sep 2026
- First submitted
- 6 May 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Corticosteroid Lumbar Epidural Analgesia for Radicular Pain (C.L.E.A.R) 2 - A Randomized, Double-blind, Active Comparator and Placebo-controlled, Multicenter, Safety and Efficacy Trial of SP-102
- ClinicalTrials.gov ID
- NCT07579351
- Acronym / sponsor ID
- CLEAR 2 / SP-102-05
- Conditions
- Lumbosacral Radicular Pain
- Keywords
- Lumbosacral Radicular Pain, Sciatica, Leg Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 755 participants (estimated)
- Lead sponsor
- Semnur Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Syngene, Cromos Pharma LLC
- Study start
- Feb 2027 (estimated)
- Primary completion
- Nov 2028 (estimated)
- Study completion
- Apr 2029 (estimated)
- First posted
- 12 May 2026 (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 research study of SP-102, an experimental medication designed to relieve pain in patients with moderate to severe sciatica (pain in the lower back, hips, buttocks and legs). SP-102, placebo (a medication that looks like SP-102 but does not contain any active ingredient), or an active comparator (dexamethasone sodium phosphate) is given once by the participant's healthcare professional. If a participant meets qualifications, each participant will have the option of receiving one supplemental open-label injection of SP-102, greater than four weeks and up to twenty weeks after their first injection.
The purpose of the study is to measure how well a single injection of the experimental medication, SP-102, relieves pain versus placebo. The study will also measure how well SP-102 relieves pain versus an active comparator medication (dexamethasone sodium phosphate). The study will also investigate the side effects of SP-102.
Detailed description
This is a double-blind, randomized, active comparator (dexamethasone sodium phosphate) and placebo-controlled, multicenter trial in participants with moderate-to-severe lumbosacral radicular pain evaluating the safety and efficacy of a single SP-102 TF injection compared to a single placebo IM injection or a single dexamethasone sodium phosphate TF injection (active comparator), followed by an open-label safety extension, evaluating an optional SP-102 TF injection, if indicated and qualified for, administered once between > 4 to 20 weeks later.
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
- Randomized, Double-blind, Active Comparator and Placebo-controlled, Multicenter, Safety and Efficacy
| Arm | Type | Receives |
|---|---|---|
| SP-102 | Experimental | Drug: SP-102 |
| Placebo Comparator | Placebo comparator | Drug: Placebo |
| dexamethasone sodium phosphate | Active comparator | Drug: Dexamethasone Sodium Phosphate 10 MG/ML |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Able and willing to read, write, and understand the English language and provide English language written informed consent prior to beginning any study procedures.
- Age 18 to 75 years (inclusive) at the Screening Visit.
- A diagnosis of lumbosacral radicular pain (sciatica) present for at least 6 weeks and not more than 9 months prior to the Screening Visit.
- Clinical symptoms consistent with the imaging (MRI)
- Agrees to follow study-specific medication requirements.
Key exclusion criteria (12 listed)
- Has a body mass index ≥40 kg/m2.
- Has radiologic evidence of a condition that would compromise study outcomes:
- Spinal cord tumor (intra- or extradural) or hematoma. Epidural or intrathecal abscess. Systemic infection.
- Has ever had lumbosacral back surgery or plans to undergo spine surgical intervention while in the study.
- Has been diagnosed with insulin dependent diabetes mellitus.
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 |
|---|---|---|
| SP-102One Injection | Drug | SP-102 |
| PlaceboOne injection | Drug | Placebo Comparator |
| Dexamethasone Sodium Phosphate 10 MG/MLOne injection | Drug | dexamethasone sodium phosphate |
Primary outcome
Mean change from baseline to W4 in the mean NPRS average daily pain score.
Time frame: Day 1 to week 4
The Numeric Pain Rating Scale (NPRS) is a self-reported scale assessing average pain intensity over the past 24 hours in the affected leg. Possible scores range from 0-10 (0 is no pain, 10 is worst pain imaginable) Change from baseline (mean of the scores recorded on the 7 days [D-7 to D-1] immediately prior to the P1 Injection Day) in mean NPRS average daily pain score in the affected leg over 4 weeks (i.e., W1, W2, W3, W4) for SP-102 versus placebo.
5 secondary outcomes
Mean change in ODI total score
Time frame: Day 1 to Week 4
Patient Global Impression of Change
Time frame: Day 1 to week 4
Mean change in BPI-Pain Interference (BPI-PI) score from P1 Baseline (D1) to P1 W4 for SP-102 versus placebo.
Time frame: Day 1 to week 4
Proportion of participants with a ≥ 30% improvement from P1 D1 to W4 in mean NPRS average daily pain score in the affected leg for SP-102 versus placebo.
Time frame: Day 1 to week 4
Proportion of participants with a ≥ 50% improvement from P1 D1 to W4 in mean NPRS average daily pain score in the affected leg for SP-102 versus placebo.
Time frame: Day 1 to week 4
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
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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.
Dmitri Lissin, Study Director, MD contact
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SP-102 and Dexamethasone Sodium Phosphate 10 MG/ML in people with Lumbosacral Radicular Pain, run by Semnur Pharmaceuticals, Inc..
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 16 inclusion and 12 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: opening soon, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Senior Director Clinical Operations (1-650-386-6709, clinicaltrials@semnurpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change from baseline to W4 in the mean NPRS average daily pain score. (time frame: Day 1 to week 4). 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 9 Sep 2026.