A Phase 3 interventional study of SP-102 and Placebo in Lumbosacral Radicular Pain, sponsored by Semnur Pharmaceuticals, Inc.. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by Semnur Pharmaceuticals, Inc. · Phase 3, Interventional, and Treatment
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.
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.
149 studies on the registry are indexed under Sciatica; 31 are open to participants now.
This study's planned enrollment of 755 is above the median of 68 across 122 interventional studies indexed under Sciatica.
Browse Sciatica studies →Semnur Pharmaceuticals, Inc. is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Main Inclusion Criteria:
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:
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. -
Exclusion Criteria:
Spinal cord tumor (intra- or extradural) or hematoma. Epidural or intrathecal abscess. Systemic infection.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: SP-102
Drug: Placebo
Drug: Dexamethasone Sodium Phosphate 10 MG/ML
One Injection
One injection
Drug page: Dexamethasone phosphate
One injection
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.
Time frame: Day 1 to week 4
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.
Time frame: 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.
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.
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).
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.
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.
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.
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.
Time frame: Day 1 to week 4
No study locations are listed for this record.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: SP-102
Semnur Pharmaceuticals, Inc.