ABTECT-Maintenance – ABX464 Treatment Evaluation for ulcerative Colitis Therapy

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Abivax

Participant type

Pediatric, Patients

Age range

0-17 years, 18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

Decision date (initial)

2023-01-11

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Abivax

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

To evaluate the efficacy of ABX464 versus placebo on clinical remission.

Secondary objectives 7

1. To evaluate the efficacy of ABX464 versus placebo on endoscopic improvement.
2. To evaluate the efficacy of ABX464 versus placebo on symptomatic remission.
3. To evaluate the efficacy of ABX464 versus placebo on corticosteroid-free clinical remission.
4. To evaluate the efficacy of ABX464 versus placebo to sustain clinical remission.
5. To evaluate the efficacy of ABX464 on histologic-endoscopic mucosal improvement (HEMI) versus placebo.
6. To evaluate the efficacy of ABX464 versus placebo on endoscopic remission.
7. To evaluate the safety profile of the different dose groups of ABX464 versus placebo.

Conditions and MedDRA coding

Moderately to severely active ulcerative colitis

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Subjects must have completed the induction treatment study (ABX464-105 or ABX464-106), and patients’ clinical response status must be available.
2. Subjects with a valid endoscopy performed at the end of the induction study and results from central reader available at Day 1.
3. Subjects must understand, sign and date the written voluntary informed consent form at the visit prior to any protocol-specific procedures. For under-aged subjects, national requirements regarding consent should also be met.
4. Women of childbearing potential (WOCBP) subjects and male subjects with WOCBP partner must agree to use highly effective contraception methods as stated in the protocol.
5. Subjects must be able and willing to comply with study visits and procedures as per protocol.
6. Subjects should be affiliated to a health insurance policy whenever required by a participating country or state.

Exclusion criteria 4

1. Subjects who permanently discontinued the study treatment during the induction study (either ABX464-105 or ABX464-106).
2. Subjects who have developed any major illness/condition or evidence of an unstable clinical condition (except ulcerative colitis) during the induction study that, in the investigator's judgment, will substantially increase the risk to the participant if he or she participates in the study.
3. Subjects who plan to participate in other investigational studies during the maintenance study.
4. Male or female planning a pregnancy within the coming 12 months.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Proportion of subjects in clinical remission at Week 44.

Secondary endpoints 11

1. Proportion of subjects with endoscopic improvement at Week 44
2. Proportion of subjects with symptomatic remission at Week 44
3. Proportion of subjects with corticosteroid-free clinical remission at Week 44.
4. Proportion of subjects with sustained clinical remission at Week 44.
5. Proportion of subjects with HEMI per Geboes scoring at Week 44
6. Proportion of subjects with endoscopic remission at Week 44.
7. Incidence of all treatment-emergent adverse events (TEAEs), causally related adverse events (AEs), all serious adverse events (SAEs) and causally related SAEs classified, by severity
8. Incidence of AEs leading to investigational medicinal product discontinuation and study discontinuation.
9. Incidence of adverse events of special interest (AESIs).
10. Incidence of clinically significant laboratory abnormalities
11. Incidence of clinically significant abnormalities regarding vital signs and ECG

Investigational products

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

Test 2

Placebo 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Abivax

Sponsor organisation

Abivax

Address

5 Rue De La Baume

City

Paris

Postcode

75008

Country

France

Scientific contact point

Organisation

Abivax

Contact name

Clinical Operations

Public contact point

Organisation

Abivax

Contact name

Clinical Operations

Third parties 7

Locations

6 EU/EEA countries · 87 investigational sites

By country

Investigational sites

Application history

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