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Long-term Safety and Efficacy of Efavaleukin Alfa in Subjects With Moderately to Severely Active Ulcerative Colitis
EU CTIS ID: 2023-506046-24-00
What this study is testing
To evaluate the long-term safety and tolerability of efavaleukin alfa in subjects with moderate to severe ulcerative colitis (UC)
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Subject has provided informed consent prior to initiation of any study specific activities/procedures
- subject has completed the week 52 endoscopy in the phase 2 parent dose-finding study (20170104) for any reason
You likely can't join if
- Permenant discontinuation of investigational product during the 52-week phase 2 dose finding study (20170104) for any reason
- Currently receiving treatment in another investigational device or drug study. Other investigational procedures while participating in this study are excluded.
- 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
- 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
- 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
- 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
See the full eligibility criteria
Who can join
- Subject has provided informed consent prior to initiation of any study specific activities/procedures
- subject has completed the week 52 endoscopy in the phase 2 parent dose-finding study (20170104) for any reason
What rules you out
- Permenant discontinuation of investigational product during the 52-week phase 2 dose finding study (20170104) for any reason
- Currently receiving treatment in another investigational device or drug study. Other investigational procedures while participating in this study are excluded.
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- Any malignancy diagnosed during Study 20170104, including evidence of cutaneous basal or squamous cell carcinoma or melanoma
- 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)
- Required systemic corticosteroid use for any indication other than UC. The only exception is corticosteroids used for the treatment of adrenal insufficiency are allowed
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- United States
- Taiwan
- Switzerland
- Mexico
- Turkey
- Korea, Republic of
- Argentina
- Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canada; United States; Taiwan; Switzerland; Mexico; Turkey and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.