Moderate to Severe Active Ulcerative Colitis (UC) MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 10017947 - Gastrointestinal disorders
Conditions
Sponsors
Amgen Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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. 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 94 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 46
Exclusion criteria
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 non-adenoma 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. 214 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the long-term safety and tolerability of efavaleukin alfa in subjects with moderate to severe ulcerative colitis (UC) ;Secondary Objective: - To evaluate the effect of efavaleukin alfa long-term treatment on clinical response - To evaluate the effect of efavaleukin alfa long-term treatment on clinical remission - To evaluate the effect of efavaleukin alfa long-term treatment on durable clinical remission - To evaluate the effect of efavaleukin alfa long-term treatment on endoscopic remission - To evaluate the effect of efavaleukin alfa long-term treatment on histologic remission - To evaluate the effect of efavaleukin alfa long-term treatment on corticosteroid-free remission - To evaluate the effect of efavaleukin alfa long-term treatment on combined endoscopic and histologic remission - To evaluate the effect of efavaleukin alfa long-term treatment on symptomatic remission - To evaluate the effect of efavaleukin alfa long-term treatment on change in histological score ;Primary end point(s): Treatment-emergent adverse events ;Timepoint(s) of evaluation of this end point: Throughout the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Clinical response at week 52 and 104 - Clinical remission at week 52 and 104 - Durable clinical remission at week 52 and 104 - Endoscopic remission at week 52 and 104 - Histologic remission at week 52 and 104 - Corticosteroid-free remission at week 52 and 104 in subjects receiving Corticosteroid receiving corticosteroids at randomization of the phase 2 parent study (Study 20170104) - Combined endoscopic and histologic remission at week 52 and 104 - Symptomatic remission at week 52 and 104 - Change from baseline of Study 20170104 in histological score (Geboes) at week 52 and 104 ;Timepoint(s) of evaluation of this end point: Weeks 52 and 104 | — |
Countries
Argentina, Austria, Belgium, Bulgaria, Canada, Czechia, Denmark, Finland, France, Germany, Greece, Hungary, Italy, Japan, Korea, Republic of, Latvia, Mexico, Netherlands, Poland, Romania, Slovakia, Spain, Switzerland, Taiwan, Türkiye, United States
Contacts
Public ContactMedical Information
Amgen GmbH
Outcome results
None listed