EXL01 in the Maintenance of Steroid-induced Clinical Response/Remission in Participants With Mild to Moderate Crohn's Disease

NCT05542355 | Terminated Phase 1 DMC

• 2 other identifiers: EXL01-CD-0012021-003432-81
• Study Type: interventional
• Target: 8
• Locations: 2 countries
• Sites: 5

Brief Summary

A Phase 1, 2-part, multicentre study to evaluate the safety and preliminary efficacy of the oral administration of EXL01 in the maintenance of corticosteroid-induced clinical response/remission in participants with mild to moderate Crohn's Disease (CD).

Conditions

Crohn Disease

Keywords

Gastrointestinal Diseases; Inflammatory Bowel Disease; Colonic Diseases; Intestinal Diseases; Digestive System Diseases; Microbiota; Crohn Disease, remission; Faecalibacterium prausnitzii

Outcome Measures

Primary Outcomes (1)

• The systemic and intestinal safety and tolerability of orally administered EXL01

  Number of participants with adverse events (AE\[s\]). Number of participants with treatment discontinuations due to an AE. AEs assessed by CTCAE v5.0

  Up to 43 weeks

Secondary Outcomes (7)

• Proportion of participants in steroid-free clinical remission at Week 24

  Maintenance Period Week 24

• Proportion of participants in steroid-free clinical remission and mucosal healing at Week 24

  Maintenance Period Week 24

• Proportion of participants in steroid free clinical remission and mucosal healing and normal inflammatory markers at Week 24

  Maintenance Period Week 24

• Proportion of participants with an endoscopic response at Week 24

  Maintenance Period Week 24

• Time to clinical relapse in participants with CD treated with EXL01 to participants treated with placebo (Part B only)

  Maintenance Period Baseline to Week 24

Study Arms (3)

Part A (Open-Label EXL01 Maintenance Therapy)

EXPERIMENTAL

Oral EXL01 once daily for up to 24 weeks (after SoC corticosteroid induction therapy).

Drug: EXL01; Other: SoC corticosteroid - Induction Period; Other: SoC corticosteroid - Tapering

Part B (EXL01 Maintenance Therapy)

EXPERIMENTAL

Oral EXL01 once daily for up to 24 weeks (after SoC corticosteroid induction therapy).

Drug: EXL01; Other: SoC corticosteroid - Induction Period; Other: SoC corticosteroid - Tapering

Part B (Placebo Maintenance Therapy)

PLACEBO COMPARATOR

Oral EXL01 matched placebo once daily for up to 24 weeks (after SoC corticosteroid induction therapy).

Drug: Placebo; Other: SoC corticosteroid - Induction Period; Other: SoC corticosteroid - Tapering

Interventions

EXL01 DRUG

Oral EXL01 once daily for up to 24 weeks (after SoC corticosteroid induction therapy).

Also known as: Faecalibacterium prausnitzii EXL01-strain

Part A (Open-Label EXL01 Maintenance Therapy); Part B (EXL01 Maintenance Therapy)

Placebo DRUG

Oral EXL01 matching placebo once daily for up to 24 weeks (after SoC corticosteroid induction therapy).

Part B (Placebo Maintenance Therapy)

SoC corticosteroid - Induction Period OTHER

Oral prednisone 40 mg or budesonide 9 mg once daily for 3 to 7 weeks, as assigned by the investigator

Part A (Open-Label EXL01 Maintenance Therapy); Part B (EXL01 Maintenance Therapy); Part B (Placebo Maintenance Therapy)

SoC corticosteroid - Tapering OTHER

Same product as the Induction Period. Oral prednisone: 30 mg for 1 week, 25 mg for 1 week, 20 mg for 1 week, 15 mg for 1 week, 10 mg for 1 week, 5 mg for 1 week and stop. OR Oral budesonide: 6 mg for 3 weeks, 3 mg for 3 weeks, stop.

Part A (Open-Label EXL01 Maintenance Therapy); Part B (EXL01 Maintenance Therapy); Part B (Placebo Maintenance Therapy)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must meet all of the following criteria at the start of the Induction Period:
• Male or female aged ≥18 years and \<75 years at the time of providing informed consent.
• A diagnosis of CD with ileal involvement for at least 3 months prior to Screening.
• A CDAI score \>180 and \<350.
• Part B only: Active mucosal inflammation.

You may not qualify if:

• Stricture with obstructive syndrome \<3 months prior to Screening.
• Stenosis making endoscopic access to the terminal ileum difficult.
• Received treatment with high dose corticosteroid (≥40 mg prednisone daily) for \>5 weeks within 3 months prior to Screening.
• Part B only: Received \>3 prior biologic treatments or JAK inhibitors for CD including infliximab, ustekinumab, vedolizumab, adalimumab, certolizumab, risankizumab, and upadacitinib.
• Major surgery or significant trauma ≤4 weeks prior to Screening.
• Small bowel resection \>1 m in total or clinical manifestations of short bowel syndrome.
• Current stoma (ileostomy or a colostomy) or had a stoma in the last 6 months or any other intraabdominal surgery within 3 months prior to Screening.
• Started or stopped immunosuppressive therapy (thiopurine, methotrexate, tacrolimus, or other classical immunosuppressant) within 3 months prior to Screening.
• Received faecal microbial transplant within 3 months prior to Screening.
• Systemic infection or other serious infection requiring systemic treatment within 30 days prior to Screening.
• Pregnant, breastfeeding, or expecting to conceive during the study.

Sponsors & Collaborators

• Exeliom Biosciences: lead
• Alimentiv Inc.: collaborator

Study Sites (5)

CHU de Liege

Liège, 4000, Belgium

Location

Zespół Poradni Specjalistycznych REUMED

Lublin, 20582, Poland

Location

Centrum Medyczne "Medyk" Sp. zo.o. Sp.K

Rzeszów, 35-326, Poland

Location

Endoskopia Sp. z o. o., Ul. B.Chrobrego 6/8

Sopot, 81-756, Poland

Location

PlanetMed Sp.z.o.o. Gastroenterology, Ul.Lubinowa 12/8

Wroclaw, 52-210, Poland

Location

MeSH Terms

Conditions

Crohn Disease; Gastrointestinal Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases; Digestive System Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis

Study Officials

• Acting Chief Medical Officer

  Exeliom Biosciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Part A: None (Open-label). Part B: Double-blind.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Part A = Single Arm open label. Part B = Randomised, placebo-controlled, double-blind.

Study Record Dates

• First Submitted: September 2, 2022
• First Posted: September 15, 2022
• Study Start: March 20, 2023
• Primary Completion: October 2, 2024
• Study Completion: October 2, 2024
• Last Updated: October 10, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1); PL (4)