A Study to Investigate safety and how well Ravagalimab (ABBV-323) works and how safe it is in Subjects with Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy

• Register: EUCTR
• Last refreshed on: 2 March 2022
• Main ID: EUCTR2018-000930-37-HU
• Date of registration: 24/06/2020
• Prospective Registration: Yes
• Primary sponsor: AbbVie Deutschland GmbH & Co. KG
• Public title: A Study to Investigate safety and how well Ravagalimab (ABBV-323) works and how safe it is in Subjects with Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy
• Scientific title: A Multicenter, Single-Arm, Open-Label Study to Investigate the Efficacy and Safety of Ravagalimab (ABBV-323) in Subjects with Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy
• Date of first enrolment: 17/08/2020
• Target sample size: 40
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2018-000930-37
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: no; Open: yes; Single blind: no; Double blind: no; Parallel group: no; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: yes; Other: no; Number of treatment arms in the trial: 1
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Canada, France, Germany, Hungary, Italy, Korea, Republic of, Netherlands, Spain, United Kingdom, United States

Contacts

• Name: EU clinical trials helpdesk
• Affiliation: AbbVie Ltd

• Name: EU clinical trials helpdesk
• Affiliation: AbbVie Ltd

Key inclusion & exclusion criteria

Inclusion criteria:
·Subjects must voluntarily sign and date an informed consent, approved by an independent ethics committee (IEC)/institutional review board (IRB), prior to the initiation of any screening or study-specific procedures.
·Adult male or female, between 18 and 75 years of age, inclusive, at time of the Baseline visit.
·Diagnosis of UC for at least 3 months prior to Baseline. Appropriate documentation of biopsy results consistent with the diagnosis of UC or in the assessment of the Investigator, must be available.
·Subject meets the following disease activity criteria: Active UC with an Adapted Mayo score of 5 to 9 points and endoscopic subscore of 2 to 3 (confirmed by central review).
·History of inadequate response, loss of response, or intolerance to one or more of the approved biologic therapies: infliximab, adalimumab, golimumab, vedolizumab, and/or tofacitinib (Note: If tofacitinib was received in a clinical trial, subject must have received open-label drug).
·Laboratory values that meet the following criteria:
- Serum aspartate transaminase (AST) and alanine transaminase (ALT) = 2 × upper limit of
normal (ULN);Total white blood cell (WBC) count = 3.0 × 10^9 /L;
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 37
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 3

Exclusion criteria:
- Subject must not have an active, chronic, or recurrent infection that based on the Investigator's clinical assessment makes the subject an unsuitable candidate for the study

- Subject must not have any malignancy except for successfully treated non metastatic cutaneous squamous cell or basal cell carcinoma or localized carcinoma in situ of the cervix.

- Subject must not have history of dysplasia of the gastrointestinal tract or evidence of dysplasia in any biopsy performed during the Screening endoscopy


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Ulcerative Colitis
MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856

Intervention(s)

Product Name: Ravagalimab
Product Code: ABBV-323
Pharmaceutical Form: Powder for concentrate for solution for injection/infusion
Current Sponsor code: ABBV-323
Other descriptive name: ABBV-323
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Powder for concentrate for solution for injection/infusion
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

Primary end point(s): The proportion of subjects with endoscopic improvement (Mayo endoscopic subscore of 0 or 1) at Week 8.

Secondary Objective: NA

Main Objective: To explore the efficacy, safety, and tolerability of Ravagalimab (ABBV-323) as treatment in subjects with moderately to severely active UC.

Timepoint(s) of evaluation of this end point: At week 8

Secondary Outcome(s)

Secondary end point(s): Secondary Endpoints (Weeks 0 to 12):
- Proportion of subjects with clinical remission per Adapted Mayo score at Week 8
- Proportion of subjects with clinical response per Adapted Mayo score at Week 8
- Proportion of subjects with clinical response per Partial Adapted Mayo score over time
- Proportion of subjects with clinical remission per Full Mayo score at Week 8 in subjects with a Full Mayo score of 6 to 12 at Baseline.
- Proportion of subjects with endoscopic remission at Week 8

Timepoint(s) of evaluation of this end point: Time points provided in E.5.2

Secondary ID(s)

M15-722

2018-000930-37-NL

Source(s) of Monetary Support

AbbVie INC

Ethics review

Status: Approved
Approval date: 06/08/2020
Contact: