Long-term Safety and Efficacy of Efavaleukin Alfa in Participants With Moderately to Severely Active Ulcerative Colitis

JRCT ID: jRCT2071230044

Registered date:21/07/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Ulcerative Colitis
• Date of first enrollment: 28/04/2023
• Target sample size: 140
• Countries of recruitment: United States,Japan,Romania,Japan,Switzerland,Japan,Argentina,Japan,Bulgaria,Japan,Denmark,Japan,Germany,Japan,Hungary,Japan,Korea,Japan,Mexico,Japan,Poland,Japan,Turkey,Japan
• Study type: Interventional

Intervention(s)

-Placebo Comparator: Placebo
Participants who were receiving the placebo during the dose-finding study (study 20170104) that decided to continue onto this long-term extension study will continue to receive the placebo.
Intervention: Drug: Placebo

-Experimental: Efavaleukin Alfa Dose 1 (Low Dose)
Participants who were receiving efavaleukin alfa dose 1 during the dose-finding study (study 20170104) that decided to continue onto this long-term extension study will continue to receive efavaleukin alfa dose 1.
Intervention: Drug: Efavaleukin alfa

-Experimental: Efavaleukin Alfa Dose 2 (Moderate Dose)
Participants who were receiving efavaleukin alfa dose 2 during the dose-finding study (study 20170104) that decided to continue onto this long-term extension study will continue to receive efavaleukin alfa dose 2.
Intervention: Drug: Efavaleukin alfa

-Experimental: Efavaleukin Alfa Dose 3 (High Dose)
Participants who were receiving efavaleukin alfa dose 3 during the dose-finding study (study 20170104) that decided to continue onto this long-term extension study will continue to receive efavaleukin alfa dose 3.
Intervention: Drug: Efavaleukin alfa

Outcome(s)

• Primary Outcome: 1. Number of Participants with Treatment-emergent Adverse Events (TEAEs) [ Time Frame: Day 1 to Week 110 ]

Secondary Outcome

1. Number of Participants with Clinical Response at Week 52 [ Time Frame: Week 52 ]
2. Number of Participants with Clinical Response at Week 104 [ Time Frame: Week 104 ]
3. Number of Participants with Clinical Remission at Week 52 [ Time Frame: Week 52 ]
4. Number of Participants with Clinical Remission at Week 104 [ Time Frame: Week 104 ]
5. Number of Participants with Durable Clinical Remission at Week 52 [ Time Frame: Week 52 ]
6. Number of Participants with Durable Clinical Remission at Week 104 [ Time Frame: Week 104 ]
7. Number of Participants with Endoscopic Remission at Week 52 [ Time Frame: Week 52 ]
8. Number of Participants with Endoscopic Remission at Week 104 [ Time Frame: Week 104 ]
9. Number of Participants with Histologic Remission at Week 52 [ Time Frame: Week 52 ]
10. Number of Participants with Histologic Remission at Week 104 [ Time Frame: Week 104 ]
11. Number of Participants with Corticosteroid-free Remission [ Time Frame: Week 52 ]
Measured in participants receiving corticosteroids at randomization of parent Study 20170104..
12. Number of Participants with Corticosteroid-free Remission [ Time Frame: Week 104 ]
Measured in participants receiving corticosteroids at randomization of parent Study 20170104.
13. Number of Participants with Combined Endoscopic and Histologic Remission at Week 52[ Time Frame: Week 52 ]
14. Number of Participants with Combined Endoscopic and Histologic Remission at Week 104[ Time Frame: Week 104 ]
15. Number of Participants with Symptomatic Remission at Week 52 [ Time Frame: Week 52 ]
16. Number of Participants with Symptomatic Remission at Week 104 [ Time Frame: Week 104 ]
17. Change from Baseline of Study 20170104 in Histological Score (Geboes) at Week 52 [ Time Frame: Baselineof Study 20170104 to Week 52 of Long Term Extension Study (up to approximately 104 weeks) ]
18. Change from Baseline of Study 20170104 in Histological Score (Geboes) at Week 104[ Time Frame: Baseline of Study 20170104 to Week 104 of Long Term Extension Study (up to approximately156 weeks) ]

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 80age old
• Gender: Both

Include criteria

1. Participant has provided informed consent prior to initiation of any study specific activities/procedures.
2. Participant has completed the week 52 endoscopy in the phase 2 dose-finding parent study (20170104) and who in the opinion of the investigator may benefit from continued treatment.

Exclude criteria

1. Permanent discontinuation of investigational product during the 52-week phase 2 dose finding parent study (20170104) for any reason
2. 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.

Disease Related:
3. Adenoma and dysplasia exclusion criteria:
-Any current sporadic adenoma without dysplasia (adenomatous polyps occurring 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 nonadenoma 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.

Other Medical Conditions:
4. Any malignancy diagnosed during parent Study 20170104, including evidence of cutaneous basal or squamous cell carcinoma or melanoma
5. 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 consultation with the Amgen physician).
6. Required systemic corticosteroid use for any indication other than ulcerative colitis. The only exception is corticosteroids used for the treatment of adrenal insufficiency are allowed.
7. 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 long term extension study.

Prior/Concurrent Clinical Study Experience:
8. Currently receiving treatment in another investigational device or drug study. Other investigational procedures while participating in this study are excluded.

Other Exclusions:
9. Female participants 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.
10. Female participants of childbearing potential unwilling to use protocol specified method of contraception see Appendix 5 (Section 11.5) during treatment and for an additional 6 weeks after the last dose of investigational product.
11. Participant has known sensitivity to any of the products to be administered during dosing with the exception of participants who exhibited sensitivity in parent Study 20170104 but did not result in treatment discontinuation.
12. Participant likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures (e.g., Clinical Outcome Assessments) to the best of the participant and investigator's knowledge.
13. Participant has a history or evidence of any other clinically significant disorder (including laboratory abnormalities), condition, or disease that, in the opinion of the investigator or Amgen physician, if consulted would pose a risk to participant safety, or interfere with the study evaluation, procedures, or completion.

Related Information

• Primary Sponsor: Hama Yoriko
• Secondary ID(s): NCT05672199