Clinical Trials Register

Summary
EudraCT Number:	2019-004943-54
Sponsor's Protocol Code Number:	STA-02
National Competent Authority:	Netherlands - Competent Authority
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2020-03-17
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Netherlands - Competent Authority

A.2

EudraCT number

2019-004943-54

A.3

Full title of the trial

A multi-country, randomized, double-blind, placebo-controlled study investigating the efficacy and safety of STA363 at two concentrations (60 mg/mL and 120 mg/mL) compared to placebo in patients with chronic discogenic low back pain

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Study investigating efficacy and safety of STA363 at two different concentrations in patients with chronic low back pain

A.4.1

Sponsor's protocol code number

STA-02

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Stayble Therapeutics AB
B.1.3.4	Country	Sweden
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Stayble Therapeutics AB
B.4.2	Country	Sweden
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Stayble Therapeutics AB
B.5.2	Functional name of contact point	Andreas Gerward, CEO
B.5.3	Address:
B.5.3.1	Street Address	Medicinaregatan 8A
B.5.3.2	Town/ city	Göteborg
B.5.3.3	Post code	SE-413 90
B.5.3.4	Country	Sweden
B.5.4	Telephone number	460730808 397
B.5.6	E-mail	info@stayble.se

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	(S)-lactic acid
D.3.2	Product code	STA363
D.3.4	Pharmaceutical form	Solution for solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intradiscal use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	(S)-LACTIC ACID
D.3.9.1	CAS number	79-33-4
D.3.9.2	Current sponsor code	STA363
D.3.9.3	Other descriptive name	(S)-LACTIC ACID
D.3.9.4	EV Substance Code	SUB11686MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	150
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	(S)-lactic acid
D.3.2	Product code	STA363
D.3.4	Pharmaceutical form	Solution for solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intradiscal use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	(S)-LACTIC ACID
D.3.9.1	CAS number	79-33-4
D.3.9.2	Current sponsor code	STA363
D.3.9.3	Other descriptive name	(S)-LACTIC ACID
D.3.9.4	EV Substance Code	SUB11686MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	300
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Solution for solution for injection
D.8.4	Route of administration of the placebo	Intradiscal use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Сhronic discogenic low back pain

E.1.1.1

Medical condition in easily understood language

Сhronic low back pain

E.1.1.2

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.0
E.1.2	Level	LLT
E.1.2	Classification code	10024891
E.1.2	Term	Low back pain
E.1.2	System Organ Class	100000004859

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

to investigate the efficacy of a single intradiscal injection of STA363 into one or two IVDs as compared to placebo by the following primary efficacy endpoint:
• Change from baseline at Month 6 in mean pain intensity measured on a 0-10 Numerical rating scale (NRS) for 7 consecutive days

E.2.2

Secondary objectives of the trial

1. to investigate the efficacy of a single intradiscal injection of STA363 into one or two IVDs as compared to placebo by the following secondary efficacy endpoints:
• Change from baseline at Month 1, Month 3 and Month 12 in mean pain intensity measured on the NRS for 7 consecutive days
• Changes from baseline at Month 1, Month 3, Month 6 and Month 12 using the following questionnaires:
o Oswestry Disability Index (ODI)
o EQ-5D-5L
• Quantitative changes in nucleus pulposus (NP) water content (reflecting transformation of NP into connective tissue) at Month 6 and Month 12 (T2-weighted magnetic resonance imaging [MRI] and quantification of T2)

2. to investigate the safety of intradiscal injection of STA363 compared to placebo
3. to investigate the efficacy of a single intradiscal injection of STA363 into one or two IVDs compared to placebo by the exploratory efficacy endpoints

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

One or two treatable IVDs of Pfirrmann grade 2 to 3 on MRI at L2/3 to L5/S1 as confirmed by a central reader, AND the following criteria are met:
a. Treatable IVD(s) must be IVD(s) with the highest Pfirrmann grade observed in the patient (e.g. a patient with one IVD of grade 3 and four IVDs of grade 2 is considered eligible only if IVD of grade 3 will be injected).
b. Patients with treatable IVD(s) of grade 2 must have all other lumbar discs rated as grade 1.
c. Not more than two IVDs of grade 3 at any lumbar level.
d. No IVDs of grade 4 or 5 at any lumbar level.

E.4

Principal exclusion criteria

Patients with more than two painful IVDs
A painful IVD above L2/3 level.
Current infection or prior history of spinal infection (e.g., discitis, septic arthritis, epidural abscess) or an active systemic infection.
Previous lumbar spine surgery.
Previous disc invasive treatment procedures at the affected level(s) (e.g., intradiscal electrothermal therapy, intradiscal radiofrequency thermocoagulation).
Evidence of prior lumbar vertebral body fracture or trauma.
Need for spinal decompression assessed by the Investigator.
Presence of IVD extrusion or sequestration.
Spondylolisthesis or retrolisthesis Grade 2 and above or spondylolysis at the index or adjacent level(s).
Lumbar spondylitis or other undifferentiated spondyloarthropathy affecting the index IVD.
Patients suffering from psychosomatic pain in the opinion of the Investigator.
Leg pain of compressive origin.

E.5 End points

E.5.1

Primary end point(s)

Change from baseline at Month 6 in mean pain intensity measured on a 0-10 Numerical rating scale (NRS) for 7 consecutive days

E.5.1.1

Timepoint(s) of evaluation of this end point

baseline and Month 6

E.5.2

Secondary end point(s)

efficacy endpoints:
• Change from baseline at Month 1, Month 3 and Month 12 in mean pain intensity measured on the NRS for 7 consecutive days
• Changes from baseline at Month 1, Month 3, Month 6 and Month 12 using the following questionnaires:
o Oswestry Disability Index (ODI)
o EQ-5D-5L
• Quantitative changes in nucleus pulposus (NP) water content (reflecting transformation of NP into connective tissue) at Month 6 and Month 12 (T2-weighted magnetic resonance imaging [MRI] and quantification of T2)

safety endpoints:
• Incidence and nature of adverse events
• Changes in physical examination findings
• Changes in vital signs (blood pressure and heart rate)
• Changes in 12-lead electrocardiogram (ECG)
• Changes in laboratory tests (hematology, clinical chemistry)
• Pain intensity at the injection site during and 15 minutes after injection (NRS)
• Changes in IVD height (T2-weighted MRI)
• Other changes in IVD morphology (e.g. frequency of asymptomatic/symptomatic disc protrusions, Modic changes, high-intensity zone [HIZ] as well as other radiology findings) (T2-weighted MRI)

exploratory efficacy endpoints:
• Percentage of patients achieving ≥30% reduction in mean NRS pain intensity score from baseline to Month 6
• Percentage of patients achieving ≥50% reduction in mean NRS pain intensity score from baseline to Month 6
• Percentage of patients achieving ≥30% improvement in ODI score
• Percentage of patients with success outcome defined as ≥50% improvement in NRS accompanied by a ≥30% improvement in ODI
• Consumption of analgesics
• Return to work
• Time to spinal fusion surgery
• Patient Global Impression of Change (PGIC) at Month 1, Month 3, Month 6, Month 12 measured by a 7-point Likert Scale

E.5.2.1

Timepoint(s) of evaluation of this end point

baseline, Month 1, Month 3, Month 6 and Month 12

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

Yes

E.6.8

Bioequivalence

E.6.9

Dose response

Yes

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Netherlands

Russian Federation

Spain

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

120

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2020-03-17.

Yes

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

126

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

None

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2020-03-17

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2020-06-15

P. End of Trial
P.	End of Trial Status	Ongoing

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