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

Phase 1

• Conditions: Moderate to Severe Active Ulcerative Colitis (UC); MedDRA version: 20.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000004856; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2022-001686-12-GR
• Lead Sponsor: Amgen Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-19
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

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

Disease Related
202 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:
1. Any history or current evidence of high-grade dysplasia.
2. 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.
3. Any history or current evidence of a nonadenoma like dysplasia associated lesions or masses, with or without evidence of dysplasia.
4. Any current sporadic adenoma containing dysplasia or any current adenoma-like dysplasia-associated lesions or masses that has not been
removed.

Other Medical Conditions
203 Any malignancy diagnosed during Study 20170104, including evidence of cutaneous basal or squamous cell carcinoma or melanoma
204 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).
205 Required systemic corticosteroid use for any indication other than UC. The only exception is corticosteroids used for the treatment of adrenal insufficiency are allowed.

Prior/Concomitant Therapy
206 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.

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

Other Exclusions
208 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.
209 Female subjects 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.
210 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.
211 Subject 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 subject and investigator’s knowledge.
212 Subject 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 subject safety, or interfere with the study evaluation, procedures, or completion.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified