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

Sponsor
Semnur Pharmaceuticals, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT03613662
Collaborator
Worldwide Clinical Trials (Other), Scilex Pharmaceuticals, Inc. (Industry)
19
1
1
8
2.4

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
19 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-label, Single-arm Study to Characterize the Pharmacodynamics and Safety of Repeat Dose SP-102 Administered by Epidural Injection in Subjects With Lumbosacral Radiculopathy
Actual Study Start Date :
Jul 13, 2018
Actual Primary Completion Date :
Mar 15, 2019
Actual Study Completion Date :
Mar 15, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: SP-102

SP-102

Drug: SP-102
Injection

Outcome Measures

Primary Outcome Measures

  1. Change in Plasma Cortisol Concentrations From Baseline [12 Weeks]

    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

  2. Change in Blood Glucose Levels From Baseline [12 Weeks]

    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

  3. Change in White Blood Cell (WBC) Levels From Baseline [12 Weeks]

    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

Secondary Outcome Measures

  1. Change in Numeric Pain Rating Scale (NPRS) Scores for Leg Pain From Baseline [12 weeks]

    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.

  2. Change in Numeric Pain Rating Scale (NPRS) Scores for Back Pain From Baseline [12 weeks]

    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.

  3. Incidence of Treatment-Emergent Adverse Events (TEAEs) [12 weeks]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Semnur Research Site 1 Boise Idaho United States 83713

Sponsors and Collaborators

  • Semnur Pharmaceuticals, Inc.
  • Worldwide Clinical Trials
  • Scilex Pharmaceuticals, Inc.

Investigators

  • Study Director: Dmitri Lissin, MD, Scilex Pharmaceuticals, Inc.

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Semnur Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT03613662
Other Study ID Numbers:
  • SP-102-03
First Posted:
Aug 3, 2018
Last Update Posted:
Jan 13, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Semnur Pharmaceuticals, Inc.

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group Title SP-102
Arm/Group Description SP-102 SP-102: Injection
Period Title: Overall Study
STARTED 19
COMPLETED 19
NOT COMPLETED 0

Baseline Characteristics

Arm/Group Title SP-102
Arm/Group Description SP-102 SP-102: Injection
Overall Participants 19
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
54.8
(14.42)
Sex: Female, Male (Count of Participants)
Female
12
63.2%
Male
7
36.8%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino
3
15.8%
Not Hispanic or Latino
16
84.2%
Unknown or Not Reported
0
0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
0
0%
Asian
0
0%
Native Hawaiian or Other Pacific Islander
0
0%
Black or African American
0
0%
White
19
100%
More than one race
0
0%
Unknown or Not Reported
0
0%
Height (cm) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [cm]
166.51
(12.294)
Weight (kg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg]
84.03
(16.412)
BMI (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]
30.51
(6.127)

Outcome Measures

1. Primary Outcome
Title Change in Plasma Cortisol Concentrations From Baseline
Description 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

Outcome Measure Data

Analysis Population Description
19 subjects were enrolled and received an index (T1) injection of SP-102. 15 subjects received a (T2) injection of SP-102. Data was not recorded for all subjects at each time point.
Arm/Group Title SP-102
Arm/Group Description SP-102 SP-102: Injection
Measure Participants 19
T1: Day 1 (predose)
36.62
(31.81)
T1: Day 2
0.64
(0.27)
T1: Day 3
6.26
(9.00)
T1: Day 4
29.77
(2.60)
T1: Day 5
39.91
(40.53)
T1: Day 8
39.71
(28.97)
T1: Day 15
44.28
(33.55)
T1: Day 28
25.08
(21.34)
T2: Day 1 (predose)
38.81
(41.10)
T2: Day 2
0.64
(0.23)
T2: Day 3
3.68
(3.85)
T2: Day 4
50.71
(56.21)
T2: Day 5
38.35
(35.00)
T2: Day 8
41.73
(38.95)
T2: Day 15
73.31
(97.64)
T2: Day 28
28.18
(20.34)
2. Primary Outcome
Title Change in Blood Glucose Levels From Baseline
Description 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

Outcome Measure Data

Analysis Population Description
19 subjects were enrolled and received an index (T1) injection of SP-102. 15 subjects received a (T2) injection of SP-102. Data was not recorded for all subjects at each time point.
Arm/Group Title SP-102
Arm/Group Description SP-102 SP-102: Injection
Measure Participants 19
T1: Day 1 (predose)
4.993
(0.5216)
T1: Day 2
6.155
(0.9009)
T1: Day 3
4.528
(0.4451)
T1: Day 4
4.676
(0.5509)
T1: Day 5
4.958
(0.4362)
T1: Day 8
5.059
(0.6597)
T1: Day 15
5.254
(0.8143)
T1: Day 28
4.963
(0.7116)
T2: Day 1 (predose)
4.867
(0.5655)
T2: Day 2
5.865
(0.8673)
T2: Day 3
4.581
(0.4986)
T2: Day 4
4.850
(0.8078)
T2: Day 5
4.959
(0.5791)
T2: Day 8
4.821
(0.4463)
T2: Day 15
5.237
(0.8394)
T2: Day 28
4.945
(0.5959)
3. Primary Outcome
Title Change in White Blood Cell (WBC) Levels From Baseline
Description 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

Outcome Measure Data

Analysis Population Description
19 subjects were enrolled and received an index (T1) injection of SP-102. 15 subjects received a (T2) injection of SP-102. Data was not recorded for all subjects at each time point.
Arm/Group Title SP-102
Arm/Group Description SP-102 SP-102: Injection
Measure Participants 19
T1: Day 1 (predose)
6.65
(2.051)
T1: Day 2
13.43
(3.726)
T1: Day 3
9.33
(2.336)
T1: Day 4
7.38
(1.863)
T1: Day 5
6.81
(1.771)
T1: Day 8
6.91
(2.212)
T1: Day 15
7.26
(1.873)
T1: Day 28
6.15
(1.339)
T2: Day 1 (predose)
6.77
(1.865)
T2: Day 2
13.43
(4.517)
T2: Day 3
9.21
(3.199)
T2: Day 4
7.88
(2.302)
T2: Day 5
7.28
(2.087)
T2: Day 8
7.31
(2.803)
T2: Day 15
8.05
(3.592)
T2: Day 28
6.07
(1.541)
4. Secondary Outcome
Title Change in Numeric Pain Rating Scale (NPRS) Scores for Leg Pain From Baseline
Description 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

Outcome Measure Data

Analysis Population Description
19 subjects were enrolled and received an index (T1) injection of SP-102. 15 subjects received a (T2) injection of SP-102. Data was not recorded for all subjects at each time point.
Arm/Group Title SP-102
Arm/Group Description SP-102 SP-102: Injection
Measure Participants 19
T1: Baseline (pre-dose)
5.4
(1.30)
T1: Day 1
5.3
(1.29)
T1: Day 2
3.2
(1.84)
T1: Day 3
2.2
(1.61)
T1: Day 4
2.5
(2.14)
T1: Day 5
2.3
(2.21)
T1: Day 8
2.5
(2.37)
T1: Day 15
3.2
(2.48)
T1: Day 28
3.4
(1.80)
T2: Baseline (pre-dose)
5.4
(1.18)
T2: Day 1
5.2
(1.32)
T2: Day 2
3.5
(2.36)
T2: Day 3
1.9
(1.28)
T2: Day 4
2.1
(1.58)
T2: Day 5
1.9
(1.53)
T2: Day 8
2.2
(2.21)
T2: Day 15
2.4
(2.21)
T2: Day 28
2.9
(2.46)
5. Secondary Outcome
Title Change in Numeric Pain Rating Scale (NPRS) Scores for Back Pain From Baseline
Description 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

Outcome Measure Data

Analysis Population Description
19 subjects were enrolled and received an index (T1) injection of SP-102. 15 subjects received a (T2) injection of SP-102. Data was not recorded for all subjects at each time point.
Arm/Group Title SP-102
Arm/Group Description SP-102 SP-102: Injection
Measure Participants 19
T1: Baseline (pre-dose)
5.2
(1.46)
T1: Day 1
5.2
(1.50)
T1: Day 2
3.5
(2.14)
T1: Day 3
2.3
(1.45)
T1: Day 4
2.7
(2.11)
T1: Day 5
2.6
(2.39)
T1: Day 8
2.8
(2.48)
T1: Day 15
3.2
(2.46)
T1: Day 28
3.9
(1.90)
T2: Baseline (pre-dose)
5.4
(1.35)
T2: Day 1
5.3
(1.35)
T2: Day 2
3.5
(2.33)
T2: Day 3
2.1
(1.55)
T2: Day 4
2.8
(1.81)
T2: Day 5
2.3
(1.35)
T2: Day 8
2.4
(2.03)
T2: Day 15
2.9
(1.96)
T2: Day 28
3.2
(2.27)
6. Secondary Outcome
Title Incidence of Treatment-Emergent Adverse Events (TEAEs)
Description Incidence of treatment-emergent AEs (TEAEs) related to study drug.
Time Frame 12 weeks

Outcome Measure Data

Analysis Population Description
19 subjects were enrolled and received an index (T1) injection of SP-102. 15 subjects received a (T2) injection of SP-102.
Arm/Group Title SP-102
Arm/Group Description SP-102 SP-102: Injection
Measure Participants 19
Treatment 1
20
Treatment 2
10

Adverse Events

Time Frame 12 weeks
Adverse Event Reporting Description
Arm/Group Title SP-102
Arm/Group Description SP-102 SP-102: Injection
All Cause Mortality
SP-102
Affected / at Risk (%) # Events
Total 0/19 (0%)
Serious Adverse Events
SP-102
Affected / at Risk (%) # Events
Total 0/19 (0%)
Other (Not Including Serious) Adverse Events
SP-102
Affected / at Risk (%) # Events
Total 13/19 (68.4%)
Gastrointestinal disorders
Abdominal discomfort 1/19 (5.3%)
Abdominal pain 1/19 (5.3%)
Abdominal pain upper 1/19 (5.3%)
Dyspepsia 2/19 (10.5%)
Food poisoning 1/19 (5.3%)
Gastrooesophageal refluxdisease 1/19 (5.3%)
General disorders
Pain 1/19 (5.3%)
Infections and infestations
Bronchitis 1/19 (5.3%)
Nasopharyngitis 2/19 (10.5%)
Respiratory tract infection 1/19 (5.3%)
Tooth abscess 2/19 (10.5%)
Investigations
Blood glucose increased 1/19 (5.3%)
White blood cell count increased 1/19 (5.3%)
Musculoskeletal and connective tissue disorders
Back pain 1/19 (5.3%)
Neck pain 1/19 (5.3%)
Nervous system disorders
Headache 7/19 (36.8%)
Migraine 1/19 (5.3%)
Skin and subcutaneous tissue disorders
Night sweats 1/19 (5.3%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The Sponsor has the right to first publication of the results of the study. Following the first publication, PIs may publish study data or results; however, the proposed publication must be submitted to the Sponsor for review and approval in writing at least sixty (60) days prior to the date of the proposed publication. Sponsor may remove from the proposed publication any information that is considered confidential and/or proprietary other than Study Data.

Results Point of Contact

Name/Title Associate Director Clinical Operations
Organization Scilex Pharmaceuticals, Inc.
Phone 6503866709
Email cambrose@scilexpharma.com
Responsible Party:
Semnur Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT03613662
Other Study ID Numbers:
  • SP-102-03
First Posted:
Aug 3, 2018
Last Update Posted:
Jan 13, 2022
Last Verified:
Jan 1, 2022