A Study With GB004 in Adult Subjects With Active Ulcerative Colitis (UC)

Gossamer Bio

Status and phase: Terminated; Phase 2

Conditions: Ulcerative Colitis

Treatments: Drug: GB004; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04556383

GB004-2101

2020-002306-12 (EudraCT Number)

Details and patient eligibility

About

A 2-part study, comprising of a 36-week placebo-controlled period (PCP) and a 24-week open-label extension (OLE) period, to assess the efficacy and safety of 2 dose regimens of GB004 when added to background UC therapy of 5-aminosalicylate (5-ASA) with or without systemic steroids.

Enrollment: 236 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult male and female subjects aged ≥ 18 years at the time of signing the informed consent form (ICF) prior to initiation of any study specific activities/procedures.

• UC diagnosed at least 3 months prior to first dose of investigational product (IP) on Day 1.

• Currently receiving treatment for UC, on a stable dose for at least 2 weeks prior to flexible sigmoidoscopy or colonoscopy, with oral 5-ASA (eg, mesalamine, sulfasalazine) alone or with one of the following oral treatments:

  1. prednisone ≤ 20 mg/day or equivalent or
  2. beclomethasone ≤ 5 mg/day or
  3. budesonide or budesonide multi-matrix (MMX) of ≤ 9 mg/day

Exclusion criteria

• Prior approved biologic therapy used for the treatment of UC.
• Diagnosis of Crohn's disease, indeterminate colitis, or pouchitis, or presence of bacterial or parasitic infection.
• Tofacitinib, oral cyclosporine, sirolimus or mycophenolate mofetil within 8 weeks of Day 1.
• Azathioprine, or 6-mercaptopurine within 1 day of Day 1.

NOTE: Other Inclusion/Exclusion criteria may apply per protocol.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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236 participants in 4 patient groups, including a placebo group

PCP Placebo

Placebo Comparator group

Description:

PCP Placebo for oral administration for 36 weeks

Treatment:

Drug: Placebo

PCP GB004 480 mg QD

Experimental group

Description:

PCP GB004 480 mg QD for oral administration for 36 weeks

Treatment:

Drug: GB004

PCP GB004 480 mg BID

Experimental group

Description:

PCP GB004 480 mg BID for oral administration for 36 weeks

Treatment:

Drug: GB004

Open-Label Extension (OLE) GB004 480 mg BID

Experimental group

Description:

OLE GB004 480 mg BID for oral administration for 24 weeks

Treatment:

Drug: GB004