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

Primary Purpose

Crohn Disease

Status

Recruiting

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

EXL01

Placebo

SoC corticosteroid - Induction Period

SoC corticosteroid - Tapering

About this trial

This is an interventional treatment trial for Crohn Disease focused on measuring Gastrointestinal Diseases, Inflammatory Bowel Disease, Colonic Diseases, Intestinal Diseases, Digestive System Diseases, Microbiota, Crohn Disease, remission, Faecalibacterium prausnitzii

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

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.
Active mucosal inflammation.

Key Exclusion Criteria:

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.
Received ≥2 prior biologic treatments for CD including infliximab, ustekinumab, vedolizumab, adalimumab, and certolizumab.
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.

Sites / Locations

Imelda Ziekenhuis BonheidenRecruiting
CHU de LiegeRecruiting
Centrum Medyczne "Medyk" Sp. zo.o. Sp.KRecruiting
Endoskopia Sp. z o. o., Ul. B.Chrobrego 6/8Recruiting
Centrum Zdrowia MDMRecruiting
Niepubliczny Zakład Opieki ZdrowotnejRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Part A (Open-Label EXL01 Maintenance Therapy)

Part B (EXL01 Maintenance Therapy)

Part B (Placebo Maintenance Therapy)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Endpoints: Crohn's disease activity index (CDAI) score (higher scores indicate more active/severe disease) and use of corticosteroids

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

This is a composite measure. Endpoints: CDAI score, simple endoscopic score for Crohn's Disease (SES-CD; higher scores indicate more severe disease), and use of corticosteroids

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

This is a composite measure. Endpoints: CDAI score, SES-CD score, C-reactive protein (CRP) level (a marker of inflammation), faecal calprotectin level (a marker of intestinal inflammation), and use of corticosteroids

Proportion of participants with an endoscopic response at Week 24

Endpoint: SES-CD score

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

Time to clinical relapse, defined as the time from first dose of EXL01 or placebo to first documented clinical relapse (Part B only)

Comparison of the SES-CD and histology of the intestinal mucosa in participants with CD treated with EXL01 to participants treated with placebo (Part B only)

This is a composite measure. Endpoints: SES-CD score, Robarts Histopathology Index score (measures histological disease activity; higher scores indicate more severe disease activity)

Comparison of the evolution of the faecal and mucosa-associated microbiota in participants with CD treated with EXL01 to participants treated with placebo (Part B only)

This is a composite measure. 16S sequencing / shotgun metagenomics and specific quantitative polymerase chain reaction (qPCR)/digital droplet (dd)PCR

Full Information

NCT ID

NCT05542355

First Posted

September 2, 2022

Last Updated

March 20, 2023

Sponsor

Exeliom Biosciences

Collaborators

Alimentiv Inc.

1. Study Identification

Unique Protocol Identification Number

NCT05542355

Brief Title

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

Acronym

MAINTAIN

Official Title

A Phase 1, Multicentre, 2-Part, Randomised, Parallel-arm, Placebo-controlled, Partially Double-blind Study to Evaluate the Safety and Target Engagement of EXL01 in the Maintenance of Steroid-induced Clinical Response or Remission in Participants With Mild to Moderate Crohn's Disease

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 20, 2023 (Actual)

Primary Completion Date

October 2025 (Anticipated)

Study Completion Date

October 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Exeliom Biosciences

Collaborators

Alimentiv Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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).

Detailed Description

Initially, all participants will received standard of care (SoC) corticosteroid induction therapy for 3 to 7 weeks. Participants who meet the protocol defined criteria for response after corticosteroid therapy will enter a Maintenance Period. Participants not in clinical response/remission at the end of the Induction Period will discontinue the study without further study treatment. In the Maintenance Period, participants will receive oral EXL01 or placebo in combination with corticosteroid treatment (that is progressively tapered) and be monitored for safety and efficacy. The study will be conducted in 2 parts: Part A: Participants eligible for maintenance treatment will receive open-label oral EXL01 for up to 24 weeks. Part B: Participants eligible for maintenance treatment will be randomised 2:1 to receive double blind oral EXL01 or placebo for up to 24 weeks. Participants will be monitored for 30 days after end-of-treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Crohn Disease

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

ParticipantInvestigatorOutcomes Assessor

Masking Description

Part A: None (Open-label). Part B: Double-blind.

Allocation

Randomized

Enrollment

67 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Part A (Open-Label EXL01 Maintenance Therapy)

Arm Type

Experimental

Arm Description

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

Arm Title

Part B (EXL01 Maintenance Therapy)

Arm Type

Experimental

Arm Description

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

Arm Title

Part B (Placebo Maintenance Therapy)

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

EXL01

Other Intervention Name(s)

Faecalibacterium prausnitzii EXL01-strain

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

SoC corticosteroid - Induction Period

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

SoC corticosteroid - Tapering

Intervention Description

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.

Primary Outcome Measure Information:

Title

The systemic and intestinal safety and tolerability of orally administered EXL01

Description

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

Time Frame

Up to 43 weeks

Secondary Outcome Measure Information:

Title

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

Description

Endpoints: Crohn's disease activity index (CDAI) score (higher scores indicate more active/severe disease) and use of corticosteroids

Time Frame

Maintenance Period Week 24

Title

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

Description

This is a composite measure. Endpoints: CDAI score, simple endoscopic score for Crohn's Disease (SES-CD; higher scores indicate more severe disease), and use of corticosteroids

Time Frame

Maintenance Period Week 24

Title

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

Description

Time Frame

Maintenance Period Week 24

Title

Proportion of participants with an endoscopic response at Week 24

Description

Endpoint: SES-CD score

Time Frame

Maintenance Period Week 24

Title

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

Description

Time to clinical relapse, defined as the time from first dose of EXL01 or placebo to first documented clinical relapse (Part B only)

Time Frame

Maintenance Period Baseline to Week 24

Title

Comparison of the SES-CD and histology of the intestinal mucosa in participants with CD treated with EXL01 to participants treated with placebo (Part B only)

Description

This is a composite measure. Endpoints: SES-CD score, Robarts Histopathology Index score (measures histological disease activity; higher scores indicate more severe disease activity)

Time Frame

Maintenance Period Baseline to Week 24

Title

Comparison of the evolution of the faecal and mucosa-associated microbiota in participants with CD treated with EXL01 to participants treated with placebo (Part B only)

Description

This is a composite measure. 16S sequencing / shotgun metagenomics and specific quantitative polymerase chain reaction (qPCR)/digital droplet (dd)PCR

Time Frame

Maintenance Period Baseline to Week 24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Key Inclusion Criteria: 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. Active mucosal inflammation. Key Exclusion Criteria: 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. Received ≥2 prior biologic treatments for CD including infliximab, ustekinumab, vedolizumab, adalimumab, and certolizumab. 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Benjamin Hadida

Phone

+33 6 72 43 72 94

bhadida@exeliombio.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Acting Chief Medical Officer

Organizational Affiliation

Exeliom Biosciences

Official's Role

Study Director

Facility Information:

Facility Name

Imelda Ziekenhuis Bonheiden

City

Antwerp

ZIP/Postal Code

2820

Country

Belgium

Individual Site Status

Recruiting

Facility Name

CHU de Liege

City

Liège

ZIP/Postal Code

4000

Country

Belgium

Individual Site Status

Recruiting

Facility Name

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

City

Rzeszów

ZIP/Postal Code

35-326

Country

Poland

Individual Site Status

Recruiting

Facility Name

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

City

Sopot

ZIP/Postal Code

81-756

Country

Poland

Individual Site Status

Recruiting

Facility Name

Centrum Zdrowia MDM

City

Warszawa

ZIP/Postal Code

00-635

Country

Poland

Individual Site Status

Recruiting

Facility Name

Niepubliczny Zakład Opieki Zdrowotnej

City

Warszawa

ZIP/Postal Code

03-580

Country

Poland

Individual Site Status

Recruiting

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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