Long-term 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

3 Jul 2023 → 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

2023-506046-24-00

EudraCT number

2022-001686-12

WHO UTN

U1111-1304-9897

ClinicalTrials.gov

NCT05672199

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

To evaluate the long-term safety and tolerability of efavaleukin alfa in subjects with moderate to severe ulcerative colitis (UC)

Secondary objectives 9

1. To evaluate the effect of efavaleukin alfa long-term treatment on clinical response
2. To evaluate the effect of efavaleukin alfa long-term treatment on clinical remission
3. To evaluate the effect of efavaleukin alfa long-term treatment on durable clinical remission
4. To evaluate the effect of efavaleukin alfa long-term treatment on endoscopic remission
5. To evaluate the effect of efavaleukin alfa long-term treatment on histologic remission
6. To evaluate the effect of efavaleukin alfa long-term treatment on corticosteroid-free remission
7. To evaluate the effect of efavaleukin alfa long-term treatment on combined endoscopic and histologic remission
8. To evaluate the effect of efavaleukin alfa long-term treatment on symptomatic remission
9. To evaluate the effect of efavaleukin alfa long-term treatment on change in histological score

Conditions and MedDRA coding

Ulcerative Colitis (UC)

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 2

1. Subject has provided informed consent prior to initiation of any study specific activities/procedures
2. subject has completed the week 52 endoscopy in the phase 2 parent dose-finding study (20170104) for any reason

Exclusion criteria 13

1. Permenant discontinuation of investigational product during the 52-week phase 2 dose finding study (20170104) for any reason
2. Subject has known sensitivity to any of the products to be administered during dosing with the exception of subjects who exhibited sensitivity in Study 20170104 but did not result in treatment discontinuation
3. Subject likely to not be available to complete all protocol-required study visits or procedures, and/or comply with all required sutdy procedures (e.g, clinical outcome assessments) to the best of the subject and invesitgator's knowledge
4. Subject has a history or evidence of any other clinically significant disorder (including laboratoy abnormalities), condition, or disease that, in the opinion of the investigator or Amgen physician, if consulted would pose a risk to subject safety, or interfere with the study evaluation, procedurs, or completion
5. adenoma and dysplasia exclusion criteria: -any current sporadic adenoma without dysplasia (adenomatous polyps occuring proximal to known areas of colitis) that has not been removed -dysplasia occurring in flat mucosa, sporadic adenomas containing dysplasia, and dysplasia-associated lesions or masses will be managed as follows: any history or current evidence of high-grade dysplasia, any history or current evidence of dysplasia occurring in flat mucosa (this includes histopathology reporting indefinite for dysplasia, low-grade dysplasia, and high-grade dysplasia), any history or current evidence of a non-adenoma like dysplasia associated lesions or masses, with or without evidence of dysplasia, any current sporadic adenoma containing dysplasia or any current adenoma-like dysplasia-associated lesions or masses that has not been removed
6. Any malignancy diagnosed during Study 20170104, including evidence of cutaneous basal or squamous cell carcinoma or melanoma
7. Active infection (including chronic, acute, recurrent, opportunistic infections) at the time of eligibility evaluation requiring intravenous (IV) anti-infectives or hospitalization (infections requiring oral and/or topical anti-infective[s] for >7 days may be allowed in consulation with the Amgen physician)
8. Required systemic corticosteroid use for any indication other than UC. The only exception is corticosteroids used for the treatment of adrenal insufficiency are allowed
9. Plan to receive a live (attenuated) vaccine during the treatment period and up to 6 weeks after the last dose of investigational product in the LTE study
10. Currently receiving treatment in another investigational device or drug study. Other investigational procedures while participating in this study are excluded.
11. Female subjects who are pregnant or breastfeeding or planning to become pregnant or breastfeed during study and for an additional 6 weeks after the last dose of investigational product
12. Female subjects of childbearing potential unwilling to use protocol specified method of contraception during treatment and for an additional 6 weeks after the last dose of investigational product
13. Female subjects of reproductive potential must agree not to donate eggs during the study and for 6 weeks after receiving the last dose of investigational product

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Treatment-emergent adverse events

Secondary endpoints 9

1. Clinical response at week 52 and 104
2. Clinical remission at week 52 and 104
3. Durable clinical remission at week 52 and 104
4. Endoscopic remission at week 52 and 104
5. Histologic remission at week 52 and 104
6. Corticosteroid-free remission at week 52 and 104 in subjects receiving corticosteroids at randomization of the phase 2 parent study (Study 20170104)
7. Combined endoscopic and histologic remission at week 52 and 104
8. Symptomatic remission at week 52 and 104
9. Change from baseline of Study 20170104 in histological score (Geboes) at week 52 and 104

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 · 65 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 7 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