The trial is taking place at:
C

Centrum Zdrowia MDM | Gastroenterology

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

E

Exeliom Biosciences

Status and phase

Enrolling
Phase 1

Conditions

Crohn Disease

Treatments

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

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT05542355
2021-003432-81 (EudraCT Number)
EXL01-CD-001

Details and patient eligibility

About

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).

Full 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.

Enrollment

67 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

67 participants in 3 patient groups, including a placebo group

Part A (Open-Label EXL01 Maintenance Therapy)
Experimental group
Description:
Oral EXL01 once daily for up to 24 weeks (after SoC corticosteroid induction therapy).
Treatment:
Drug: EXL01
Other: SoC corticosteroid - Tapering
Other: SoC corticosteroid - Induction Period
Part B (EXL01 Maintenance Therapy)
Experimental group
Description:
Oral EXL01 once daily for up to 24 weeks (after SoC corticosteroid induction therapy).
Treatment:
Drug: EXL01
Other: SoC corticosteroid - Tapering
Other: SoC corticosteroid - Induction Period
Part B (Placebo Maintenance Therapy)
Placebo Comparator group
Description:
Oral EXL01 matched placebo once daily for up to 24 weeks (after SoC corticosteroid induction therapy).
Treatment:
Drug: Placebo
Other: SoC corticosteroid - Tapering
Other: SoC corticosteroid - Induction Period

Trial contacts and locations

7

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Central trial contact

Benjamin Hadida

Data sourced from clinicaltrials.gov

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