Corticosteroid Lumbar Epidural Analgesia for Radicular Pain 2

NCT07579351 | Not Yet Recruiting Phase 3 FDA Drug

• 1 other identifier: SP-102-05
• Study Type: interventional
• Target: 755
• Locations: 0 countries
• Sites: N/A

Brief 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). 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.

Conditions

Lumbosacral Radicular Pain

Keywords

Lumbosacral Radicular Pain; Sciatica; Leg Pain

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 1 to week 4

Secondary Outcomes (5)

• Mean change in ODI total score

  Day 1 to Week 4

• Patient Global Impression of Change

  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.

  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.

  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.

  Day 1 to week 4

Study Arms (3)

SP-102

EXPERIMENTAL

Drug: SP-102

Placebo Comparator

PLACEBO COMPARATOR

Drug: Placebo

dexamethasone sodium phosphate

ACTIVE COMPARATOR

Drug: Dexamethasone Sodium Phosphate 10 MG/ML

Interventions

SP-102 DRUG

One Injection

SP-102

Placebo DRUG

One injection

Placebo Comparator

Dexamethasone Sodium Phosphate 10 MG/ML DRUG

One injection

dexamethasone sodium phosphate

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Semnur Pharmaceuticals, Inc.: lead
• Syngene: collaborator
• Cromos Pharma LLC: collaborator

MeSH Terms

Conditions

Sciatica

Interventions

dexamethasone 21-phosphate

Condition Hierarchy (Ancestors)

Sciatic Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neuralgia; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Senior Director Clinical Operations

CONTACT

1-650-386-6709; clinicaltrials@semnurpharma.com

Dmitri Lissin, Study Director, MD

CONTACT

1-650-422-7515

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, Double-blind, Active Comparator and Placebo-controlled, Multicenter, Safety and Efficacy

Study Record Dates

• First Submitted: May 6, 2026
• First Posted: May 12, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): January 1, 2029
• Last Updated: May 12, 2026

Record last verified: 2026-05