A Phase 2 Long-Term Extension (LTE) Study to Evaluate The Safety and Efficacy of Efavaleukin Alfa in Subjects With Moderately to Severely Active Ulcerative Colitis

Phase 2

• Conditions: Colitis gravis; Inflammatory bowel disease; 10017969

• Registration Number: NL-OMON56326
• Lead Sponsor: Amgen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 6

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 parent
dose-finding study (20170104) and who in the opinion of the investigator may
benefit from continued treatment.

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:
o Any current sporadic adenoma without dysplasia (adenomatous polyps
occurring proximal to known areas of colitis) that has not been removed.
o 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
topicalanti-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 inthe 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 exhibitedsensitivity 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
• Study Design: Not specified