A Pilot / Phase 2 Clinical Trial of GSL-01-001 Administered Orally for 12 Weeks Preceded by a 2 Week Screening Period in Patients Presenting with Symptoms Associated with Irritable Bowel Syndrome with code GSL-01-001

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Cannabibs Sp. z o.o.

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

Trial duration

25 Feb 2025 → ongoing

Decision date (initial)

2024-09-30

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

To assess the effectiveness of GSL-01-001 at controlling the symptoms associated with Irritable Bowel Syndrome with diarrhea including abdominal pain, cramping, nausea, bloating, distention, diarrhea and constipation.
To assess the safety of GSL-01-001 in the patient population.

Secondary objectives 1

1. To assess the effectiveness of GSL-01-001 at improving quality of life (QoL) metrics, including anxiety, overall general perception of health, physical health, mental health, and overall pain.

Conditions and MedDRA coding

Irritable Bowel Syndrome (IBS) type D

Study design 2 periods

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 11

1. >=18 <=50 years old male and female
2. BMI >18 <40 kg/m2
3. Patient has a diagnosis of IBS-D
4. Has an average abdominal pain score of ≥5.5 at baseline.
5. If treated with any of the following medicaAons, dosing must be stable for 90 days prior to Screening and the subject must agree to maintain the same dose of medicaAon throughout the study: - Tricyclic anAdepressants, tetracyclic anAdepressants, selecAve serotonin reuptake inhibitors (SSRIs), and serotonin and norepinephrine reuptake inhibitors (SNRIs) for condiAons other than IBS pain, - Benzodiazepines or non-benzodiazepine hypnoAcs, administered at bedAme for condiAons other than IBS pain
6. Patient has stable eaten habits for the past 12 weeks and is not planning to change his/her lifestyle and/or diet during the study
7. Female patients if they are post-menopausal or sterilized, or if they are of childbearing potential and their pregnancy test is negative
8. All patients of childbearing potential must agree to use highly effective birth control method(s) throughout the study, and for at least 30 days after receiving the last dose of study drug; females using oral contraception must have started using the medication at least 30 days prior to screening; surgical sterilization must have occurred at least 6 weeks prior to screening.
9. Male patients must agree not to donate sperm for 30 days ager receiving study drug.
10. Ability to complete the study in compliance with the protocol; and
11. Ability to understand and provide written informed consent.

Exclusion criteria 13

1. All subjects with recent (within 6 months of Screening) or ongoing alarm features (unexplained weight loss, nocturnal symptoms, blood mixed with stool, family history of colorectal cancer or inflammatory bowel disease) without colonoscopy performed at most five years before the study screening visit (as per Appendix 1 point 1).
2. Patients with diagnosis or history of inflammatory bowel disease (IBD), colorectal cancer, diverticulitis, ischemic colitis, microscopic colitis, bile acid diarrhea, or celiac disease.
3. Clinically relevant changes in dietary, lifestyle, or exercise regimen within 30 days prior to Visit 1 (Screening) that may confound efficacy assessments in the clinical judgment of the InvesAgator (or designee).
4. Diagnosis of small intestine bacterial overgrowth (SIBO)
5. Any colonic or major abdominal surgery (e.g., bariatric surgery [including gastric banding], cholecystectomy, stomach surgery, small/large bowel surgery, or abdominal large vessel surgery). Procedures such as appendectomy, hysterectomy, cesarean section, or polypectomy are allowed if they have occurred at least 3 months prior to Visit 1 (Screening).
6. Other GI diseases such as peptic ulceration, functional dyspepsia, GI bleeding, or GI inflammatory disease (e.g., esophagitis, gastritis, or duodenitis) within 6 months prior to Visit 1 (Screening).
7. Pregnant, lactation or planning to become pregnant in the course of the study.
8. Use of any of the following medications within 30 days prior to Visit 1 (Screening): - Opioids - The following are excluded if they are prescribed for IBS pain anticonvulsants (e.g., pregabalin or gabapenAn) - Medical or recreational marijuana, tetrahydrocannabinol (THC), cannabidiol (CBD), any other minor cannabinoid (CBG, CBDA, CBN etc.) synthetic cannabinoids, and other cannabis derivatives for any indication.
9. Benzodiazepines, or non-benzodiazepine hypnotics, unless administered at bedtime for conditions other than IBS pain (stable by 90 days or not use by last 30 days).
10. Use of the medications - prior (within 14 days before Visit 2) or anticipated concomitant prescription medication or OTC therapy for IBS including, but not limited to, abdominal pain medications, antibiotics, anticholinergics, antidiarrheals, antiflatulence agents, antispasmodics, chloride channel activators, bile acid sequestrants, cholinomimetics, 5-HT3 antagonists, 5-HT4 agonists, guanylate cyclase C agonists, opioid agonists or antagonists, osmotic laxatives, stimulant laxatives.
11. Use prior (within 30 days of Visit 1) or anticipated concomitant use of GI antibiotics.
12. Ongoing or planned use of a concomitant medication that is on the CredibleMedsTM list of drugs known to cause Torsades des Pointes (Appendix 5).
13. Participation in another clinical trial before 30 days prior Visit 1 (Screening) or planning participation in another clinical study during this study.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Primary safety endpoints include the evaluation of AEs and SAEs (in case of SAE with deaths and relation to IMP).
2. Primary efficacy endpoints include change from Baseline in scores at each week of abdominal bloating, discomfort, pain, cramping and nausea as well as stool consistency response: the average BSFS score of all reported bowel movements on the specific day (daily average).

Secondary endpoints 1

1. Change from Baseline in abdominal pain, diarrhea, stool consistency, abdominal discomfort, bloating and cramping, nausea, percent change in abdominal pain – all at their worst; 6/12 week responder from Baseline in abdominal pain (≥30% decrease and ≥2-point improvement), abdominal discomfort (≥2-point improvement), bloating (≥2-point improvement and increase of ≥1 CSBM/week); treatment satisfaction; adequate relief; change in diarrhea and QOL assessment at weeks 4, 8 and 12.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Cannabibs Sp. z o.o.

Sponsor organisation

Cannabibs Sp. z o.o.

Address

Ul. Marszalkowska 58/15

City

Warsaw

Postcode

00-545

Country

Poland

Scientific contact point

Organisation

Cannabibs Sp. z o.o.

Contact name

Clinical Trial Department

Public contact point

Organisation

Cannabibs Sp. z o.o.

Contact name

Clinical Trial Department

Third parties 2

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 10 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications