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CompletedNCT03613662Updated Jan 13, 2022Results posted

A Research Study to Characterize the Pharmacodynamics and Safety of Repeat Dose SP-102

A Phase 2 interventional study of SP-102 in Lumbosacral Radicular Pain, sponsored by Semnur Pharmaceuticals, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-01-13.

Sponsored by Semnur Pharmaceuticals, Inc. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
19
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study summary

This is an open-label, single-arm, repeat dose study to characterize the pharmacodynamics and safety/tolerability of SP-102 administered by epidural injection.

02

Conditions studied

  • Lumbosacral Radicular Pain

Keywords

  • lumbosacral radicular pain
  • sciatica
  • leg pain
03

In context

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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 70 years (inclusive) at the Screening Visit.
  • A diagnosis of lumbosacral radicular pain (sciatica).
  • 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.

Main Exclusion Criteria:

  • Has radiologic evidence of a condition that would compromise study outcomes.
  • 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 a body mass index ≥40 kg/m2.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
19 participants (actual)

Study arms

  • Experimental
    SP-102

    SP-102

    Drug: SP-102

Interventions

  • DrugSP-102

    Injection

06

What researchers measure

Primary outcomes

  1. Change in Plasma Cortisol Concentrations From Baseline

    Dexamethasone-induced hypothalamic-pituitary-adrenal (HPA) suppression is evaluated by monitoring SP-102 induced changes in plasma cortisol levels from Baseline. The T1 (index) and T2 (repeat) injections of SP-102 are separated by 4-8 weeks

    Time frame: 12 Weeks

  2. Change in Blood Glucose Levels From Baseline

    Dexamethasone-induced hypothalamic-pituitary-adrenal (HPA) suppression is evaluated by monitoring SP-102 induced changes in blood glucose levels from Baseline. The T1 (index) and T2 (repeat) injections of SP-102 are separated by 4-8 weeks

    Time frame: 12 Weeks

  3. Change in White Blood Cell (WBC) Levels From Baseline

    Dexamethasone-induced hypothalamic-pituitary-adrenal (HPA) suppression is evaluated by monitoring SP-102 induced changes in WBC levels from Baseline. The T1 (index) and T2 (repeat) injections of SP-102 are separated by 4-8 weeks

    Time frame: 12 Weeks

Secondary outcomes

  1. Change in Numeric Pain Rating Scale (NPRS) Scores for Leg Pain From Baseline

    The NPRS is an 11-point scale (0- to 10-point scale where 0 is no pain and 10 is worst pain imaginable) that allows subjects to rate the severity of their pain intensity at various points in time (Turk et al., 2003). Subjects used the NPRS to record their current pain, average pain over 24 hours, and worst pain over 24 hours for both affected leg(s) and back pain. NPRS average leg pain scores over 24 hours are presented.

    Time frame: 12 weeks

  2. Change in Numeric Pain Rating Scale (NPRS) Scores for Back Pain From Baseline

    The NPRS is an 11-point scale (0- to 10-point scale where 0 is no pain and 10 is worst pain imaginable) that allows subjects to rate the severity of their pain intensity at various points in time (Turk et al., 2003). Subjects used the NPRS to record their current pain, average pain over 24 hours, and worst pain over 24 hours for both affected leg(s) and back pain. NPRS average back pain scores over 24 hours are presented.

    Time frame: 12 weeks

  3. Incidence of Treatment-Emergent Adverse Events (TEAEs)

    Incidence of treatment-emergent AEs (TEAEs) related to study drug.

    Time frame: 12 weeks

07

Results

Posted Jan 13, 2022

Participant flow

Participant flow — Overall Study
MilestoneSP-102
Started19
Completed19
Not completed0

Outcome measures

PrimaryChange in Plasma Cortisol Concentrations From Baseline

Dexamethasone-induced hypothalamic-pituitary-adrenal (HPA) suppression is evaluated by monitoring SP-102 induced changes in plasma cortisol levels from Baseline. The T1 (index) and T2 (repeat) injections of SP-102 are separated by 4-8 weeks

Time frame:
12 Weeks
Reported as:
Mean · nmol/L
Change in Plasma Cortisol Concentrations From Baseline
nmol/LSP-102
T1: Day 1 (predose)36.62 ± 31.81
T1: Day 20.64 ± 0.27
T1: Day 36.26 ± 9.00
T1: Day 429.77 ± 2.60
T1: Day 539.91 ± 40.53
T1: Day 839.71 ± 28.97
T1: Day 1544.28 ± 33.55
T1: Day 2825.08 ± 21.34
T2: Day 1 (predose)38.81 ± 41.10
T2: Day 20.64 ± 0.23
T2: Day 33.68 ± 3.85
T2: Day 450.71 ± 56.21
T2: Day 538.35 ± 35.00
T2: Day 841.73 ± 38.95
T2: Day 1573.31 ± 97.64
T2: Day 2828.18 ± 20.34
PrimaryChange in Blood Glucose Levels From Baseline

Dexamethasone-induced hypothalamic-pituitary-adrenal (HPA) suppression is evaluated by monitoring SP-102 induced changes in blood glucose levels from Baseline. The T1 (index) and T2 (repeat) injections of SP-102 are separated by 4-8 weeks

Time frame:
12 Weeks
Reported as:
Mean · nmol/L
Change in Blood Glucose Levels From Baseline
nmol/LSP-102
T1: Day 1 (predose)4.993 ± 0.5216
T1: Day 26.155 ± 0.9009
T1: Day 34.528 ± 0.4451
T1: Day 44.676 ± 0.5509
T1: Day 54.958 ± 0.4362
T1: Day 85.059 ± 0.6597
T1: Day 155.254 ± 0.8143
T1: Day 284.963 ± 0.7116
T2: Day 1 (predose)4.867 ± 0.5655
T2: Day 25.865 ± 0.8673
T2: Day 34.581 ± 0.4986
T2: Day 44.850 ± 0.8078
T2: Day 54.959 ± 0.5791
T2: Day 84.821 ± 0.4463
T2: Day 155.237 ± 0.8394
T2: Day 284.945 ± 0.5959
PrimaryChange in White Blood Cell (WBC) Levels From Baseline

Dexamethasone-induced hypothalamic-pituitary-adrenal (HPA) suppression is evaluated by monitoring SP-102 induced changes in WBC levels from Baseline. The T1 (index) and T2 (repeat) injections of SP-102 are separated by 4-8 weeks

Time frame:
12 Weeks
Reported as:
Mean · cell count × 10^9/L
Change in White Blood Cell (WBC) Levels From Baseline
cell count × 10^9/LSP-102
T1: Day 1 (predose)6.65 ± 2.051
T1: Day 213.43 ± 3.726
T1: Day 39.33 ± 2.336
T1: Day 47.38 ± 1.863
T1: Day 56.81 ± 1.771
T1: Day 86.91 ± 2.212
T1: Day 157.26 ± 1.873
T1: Day 286.15 ± 1.339
T2: Day 1 (predose)6.77 ± 1.865
T2: Day 213.43 ± 4.517
T2: Day 39.21 ± 3.199
T2: Day 47.88 ± 2.302
T2: Day 57.28 ± 2.087
T2: Day 87.31 ± 2.803
T2: Day 158.05 ± 3.592
T2: Day 286.07 ± 1.541
SecondaryChange in Numeric Pain Rating Scale (NPRS) Scores for Leg Pain From Baseline

The NPRS is an 11-point scale (0- to 10-point scale where 0 is no pain and 10 is worst pain imaginable) that allows subjects to rate the severity of their pain intensity at various points in time (Turk et al., 2003). Subjects used the NPRS to record their current pain, average pain over 24 hours, and worst pain over 24 hours for both affected leg(s) and back pain. NPRS average leg pain scores over 24 hours are presented.

Time frame:
12 weeks
Reported as:
Mean · score on a scale
Change in Numeric Pain Rating Scale (NPRS) Scores for Leg Pain From Baseline
score on a scaleSP-102
T1: Baseline (pre-dose)5.4 ± 1.30
T1: Day 15.3 ± 1.29
T1: Day 23.2 ± 1.84
T1: Day 32.2 ± 1.61
T1: Day 42.5 ± 2.14
T1: Day 52.3 ± 2.21
T1: Day 82.5 ± 2.37
T1: Day 153.2 ± 2.48
T1: Day 283.4 ± 1.80
T2: Baseline (pre-dose)5.4 ± 1.18
T2: Day 15.2 ± 1.32
T2: Day 23.5 ± 2.36
T2: Day 31.9 ± 1.28
T2: Day 42.1 ± 1.58
T2: Day 51.9 ± 1.53
T2: Day 82.2 ± 2.21
T2: Day 152.4 ± 2.21
T2: Day 282.9 ± 2.46
SecondaryChange in Numeric Pain Rating Scale (NPRS) Scores for Back Pain From Baseline

The NPRS is an 11-point scale (0- to 10-point scale where 0 is no pain and 10 is worst pain imaginable) that allows subjects to rate the severity of their pain intensity at various points in time (Turk et al., 2003). Subjects used the NPRS to record their current pain, average pain over 24 hours, and worst pain over 24 hours for both affected leg(s) and back pain. NPRS average back pain scores over 24 hours are presented.

Time frame:
12 weeks
Reported as:
Mean · score on a scale
Change in Numeric Pain Rating Scale (NPRS) Scores for Back Pain From Baseline
score on a scaleSP-102
T1: Baseline (pre-dose)5.2 ± 1.46
T1: Day 15.2 ± 1.50
T1: Day 23.5 ± 2.14
T1: Day 32.3 ± 1.45
T1: Day 42.7 ± 2.11
T1: Day 52.6 ± 2.39
T1: Day 82.8 ± 2.48
T1: Day 153.2 ± 2.46
T1: Day 283.9 ± 1.90
T2: Baseline (pre-dose)5.4 ± 1.35
T2: Day 15.3 ± 1.35
T2: Day 23.5 ± 2.33
T2: Day 32.1 ± 1.55
T2: Day 42.8 ± 1.81
T2: Day 52.3 ± 1.35
T2: Day 82.4 ± 2.03
T2: Day 152.9 ± 1.96
T2: Day 283.2 ± 2.27
SecondaryIncidence of Treatment-Emergent Adverse Events (TEAEs)

Incidence of treatment-emergent AEs (TEAEs) related to study drug.

Time frame:
12 weeks
Reported as:
Number · events
Incidence of Treatment-Emergent Adverse Events (TEAEs)
eventsSP-102
Treatment 120
Treatment 210

Adverse events

Collected over 12 weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
SP-1020/19 (0%)0/19 (0%)13/19 (68.4%)
Most frequent other events
Showing 10 of 18
Most frequent other events
EventSP-102
HeadacheNervous system disorders7/19
DyspepsiaGastrointestinal disorders2/19
NasopharyngitisInfections and infestations2/19
Tooth abscessInfections and infestations2/19
Abdominal discomfortGastrointestinal disorders1/19
Abdominal painGastrointestinal disorders1/19
Abdominal pain upperGastrointestinal disorders1/19
Food poisoningGastrointestinal disorders1/19
Gastrooesophageal refluxdiseaseGastrointestinal disorders1/19
PainGeneral disorders1/19

Baseline characteristics

Age, Continuous
Age, Continuous(years)SP-102
Mean54.8 ± 14.42
Sex: Female, Male
Sex: Female, Male(Participants)SP-102
Female12
Male7
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)SP-102
Hispanic or Latino3
Not Hispanic or Latino16
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)SP-102
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American0
White19
More than one race0
Unknown or Not Reported0
Height
Height(cm)SP-102
Mean166.51 ± 12.294
Weight
Weight(kg)SP-102
Mean84.03 ± 16.412
BMI
BMI(kg/m^2)SP-102
Mean30.51 ± 6.127
08

Study locations

1 site
  • Semnur Research Site 1
    Boise, Idaho 83713, United States
09

References and documents

Publications

  • Radnovich R, Heinz J, Ambrose C, Stannard E, Lissin D. Repeat Epidural Injections of SP-102 (Dexamethasone Sodium Phosphate Injectable Gel) in Subjects with Lumbosacral Radiculopathy. J Pain Res. 2021 May 5;14:1231-1239. doi: 10.2147/JPR.S303282. eCollection 2021. PubMed 33981160 ↗

Study documents

  • Study protocol · Jun 8, 2018
  • Statistical analysis plan · Feb 5, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 13, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03613662
Lead sponsor
Semnur Pharmaceuticals, Inc.
Collaborators
Worldwide Clinical Trials, Scilex Pharmaceuticals, Inc.
Responsible party
Sponsor
First posted
Aug 3, 2018
Start date
Jul 13, 2018
Primary completion
Mar 15, 2019
Completion
Mar 15, 2019
Results posted
Jan 13, 2022
Last update
Jan 13, 2022

Study contacts

Dmitri Lissin, MD
study director · Scilex Pharmaceuticals, Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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