Effects of ABX464 during long-term treatment in patients with moderate to severe ulcerative colitis

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Abivax

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

Trial duration

1 Dec 2021 → ongoing

Decision date (initial)

2024-06-17

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Abivax

External identifiers

EU CT number

2023-507974-42-00

EudraCT number

2021-004398-30

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

The primary objective of the study is to evaluate the long-term safety of ABX464 given at 25 mg once daily in subjects with Moderate to Severe Active Ulcerative Colitis.

Conditions and MedDRA coding

Moderate to Severe Ulcerative Colitis

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Subjects who previously completed the ABX464-102 or ABX464-104 clinical studies
2. Subjects should be in endoscopic improvement with a rectal bleeding sub-score = 0 point at the end of treatment period in the previous study (ABX464-102 or ABX464-104). Endoscopic improvement is defined as: a Mayo endoscopic sub score of ≤1 with a rectal bleeding sub-score = 0 point
3. Subjects able and willing to comply with study visits and procedures
4. Subjects must understand, sign and date the written voluntary informed consent form at the visit prior to any protocol-specific procedures
5. Women of childbearing potential and men receiving the study treatment and their partners must agree to use highly effective contraceptive method during the study and for at least 4-week follow-up (i.e. 4 weeks after last IMP intake). Women must be surgically sterile or if of childbearing potential must use a highly effective contraceptive method. Women of childbearing potential (WOCBP) will enter the study after confirmed menstrual period and a negative pregnancy test. The WOCBP must be willing to perform once a month a urine pregnancy test. Highly effective methods of contraception include true abstinence, intrauterine device (IUD) or hormonal contraception aiming at inhibition of ovulation, intrauterine hormone releasing system, bilateral tubal ligation, vasectomized partner. True abstinence is defined when this is in line with the preferred and usual lifestyle of the subject. This recommendation also applies to WOCBP with infrequent or irregular menstrual cycle. Female and male subjects must not be planning pregnancy during the trial and for at least 4-week follow-up (i.e. 4 weeks after last IMP intake). In addition, male subjects should use condom during the trial and for at least 4-week follow-up (i.e. 4 weeks after last IMP intake). Male subjects must not donate sperm and female subjects must not donate oocytes as long as contraception is required. For the purpose of this protocol, a woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A post-menopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the post-menopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. Finally, a man is considered fertile after puberty unless permanently sterile by bilateral orchidectomy
6. Subjects should be affiliated to a social security regimen (for French sites only)

Exclusion criteria 3

1. Subjects who have developed any major illness/condition or evidence of an unstable clinical condition (except UC) that, in the investigator's judgment, will substantially increase the risk to the participant if he or she participates in the study
2. Subjects with any other severe acute or chronic medical or psychiatric condition or laboratory or electrocardiogram (ECG) abnormality that may increase the risk associated with study participation or nvestigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study
3. Subjects who are participating or plan to participate in other investigational studies (other than induction study) during the study

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Number of Adverse Events (AEs) in ABX464 treated subjects.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Abivax

Sponsor organisation

Abivax

Address

7 Boulevard Haussmann

City

Paris

Postcode

75009

Country

France

Scientific contact point

Organisation

Abivax

Contact name

Clinical Operations

Public contact point

Organisation

Abivax

Contact name

Clinical Operations

Third parties 8

Locations

11 EU/EEA countries · 40 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 137 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

8 submissions — initial application plus substantial / non-substantial modifications