Safety and Efficacy of Efavaleukin Alfa in Subjects with Moderately to Severely Active Ulcerative Colitis

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Amgen Inc.

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 Mar 2022 → 27 Aug 2024

Decision date (initial)

2024-05-31

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Amgen Inc.

External identifiers

EU CT number

2023-506004-93-00

EudraCT number

2021-002537-41

WHO UTN

U1111-1304-1476

ClinicalTrials.gov

NCT04987307

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

To evaluate the effect of efavaleukin alfa on induction of clinical remission.

Secondary objectives 6

1. To evaluate the effect of efavaleukin alfa on induction of clinical response.
2. To evaluate the effect of efavaleukin alfa on induction of endoscopic remission.
3. To evaluate the effect of efavaleukin alfa on induction of symptomatic remission.
4. To evaluate the effect of efavaleukin alfa as induction therapy on combined endoscopic and histologic remission.
5. To evaluate the effect of efavaleukin alfa as induction therapy on change in histological score.
6. To evaluate the safety and tolerability of efavaleukin alfa.

Conditions and MedDRA coding

Ulcerative Colitis (UC)

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share IPD

Yes

IPD plan description

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request. Information on IPD sharing Access Criteria, Time Frame and Supporting Information Type is available at ClinicalTrials.gov (https://clinicaltrials.gov/study/NCT04987307) and at Amgen Clinical Trials portal (http://www.amgen.com/datasharing).

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Subject has provided informed consent prior to initiation of any study specific activities or procedures.
2. Diagnosis of UC established >= 3 months prior to enrollment by clinical and endoscopic evidence and corroborated by a histopathology report.
3. Moderately to severely active UC as defined by a modified Mayo score of 5 to 9, with a centrally read endoscopy score >= 2.
4. Subjects must have demonstrated inadequate response, loss of response, or intolerance to at least 1 conventional therapy, biologic therapy, or targeted small molecule therapy (ie, JAK-inhibitor).
5. Subjects must have stable doses of oral 5-aminosalicylaltes (ASA; stable dose for >= 2 weeks), oral corticosteroids (dose must be <=20mg/day prenisone or its equivalent and must have been stable for >= 2 weeks), budesonide (extended release tablets 9mg/day; stable dose for >= 2 weeks), beclomethasone dipropionate (gastro-resistant prolongued-release tablet 5mg/day; stable dose for >=2 weeks), and conventional immunomodulators (azathioprine, 6-mercaptopurine, methotrexate; stable dose for >=12 weeks).
6. Age >= 18 years to <80years at screening visit, except in South Korea where age >= 19 years to <80 years at screening visit.

Exclusion criteria 4

1. Subjects with diagnosis of Crohn's disease, inflammatory bowel disease-unclassified (indeterminate colitis), microscopic colitis, ischemic colitis, or clinical findings suggestive of Crohn’s disease.
2. Subjects with UC limited to the rectum (ie, within 15cm of the anal verge).
3. Subjects with evidence of toxic megacolon, fulminant colitis, intra-abdominal abscess, or stricture/stenosis within the small bowel or colon.
4. Subjects with a history or colectomy.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Clinical remission at week 12

Secondary endpoints 6

1. Clinical response at week 12
2. Endoscopic remission at week 12
3. Symptomatic remission at week 12
4. Combined endoscopic remission and histologic remission of the colon tissue at week 12
5. Change from baseline in histological score at week 12 as measured by Geboes score
6. Treatment-emergent adverse events

Investigational products

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

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Amgen Inc.

Sponsor organisation

Amgen Inc.

Address

1 Amgen Center Drive

City

Thousand Oaks

Postcode

91320-1799

Country

United States

Scientific contact point

Organisation

Amgen Inc.

Contact name

Medical Information

Public contact point

Organisation

Amgen Inc.

Contact name

Medical Information

Third parties 9

Locations

17 EU/EEA countries · 69 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

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 21 files

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

Application history

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