A Phase 1b Proof-of-concept Trial Exploring the Effects of FE 999322 and FE 999324 in Adults With Mild to Moderate Ulcerative Colitis

Ferring

Status and phase: Withdrawn; Phase 1

Conditions: Ulcerative Colitis

Treatments: Drug: Placebo suspension; Drug: Microbiota capsule; Drug: Placebo capsule; Drug: Microbiota suspension

Study type: Interventional

Funder types: Industry

Identifiers

NCT06260267

000417

Details and patient eligibility

About

To explore the safety of FE 999322 (microbiota suspension) and FE 999324 (microbiota capsule) versus placebo in subjects with active mild to moderate ulcerative colitis (UC).

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject aged ≥18 at screening
• Established diagnosis of ulcerative colitis by standard clinical, endoscopic and histological criteria, for more than 3 months at screening

Exclusion criteria

• Active disease or history of Crohn's disease
• Active disease or history of irritable bowel syndrome (IBS) or any other chronic intestinal disease apart from UC
• Active gastrointestinal infection.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 4 patient groups, including a placebo group

FE 999322

Experimental group

Description:

Microbiota suspension

Treatment:

Drug: Microbiota suspension

FE 999324

Experimental group

Description:

Microbiota capsule

Treatment:

Drug: Microbiota capsule

Placebo FE 999322

Placebo Comparator group

Description:

Placebo suspension

Treatment:

Drug: Placebo suspension

Placebo FE 999324

Placebo Comparator group

Description:

Placebo capsule

Treatment:

Drug: Placebo capsule