An Efficacy and Safety Study of LYC-30937-EC in Subjects With Active Ulcerative Colitis
A Randomized, Double-Blind, Placebo-Controlled Parallel Group Study to Assess the Efficacy and Safety of Induction Therapy With LYC-30937-EC in Subjects With Active Ulcerative Colitis
調査の概要
詳細な説明
Approximately 120 subjects will be randomized to receive either enteric-coated (EC) LYC-30937-EC 25 mg PO once daily (QD) or matching placebo PO QD for the duration of 8 weeks. Randomization will be stratified based on previous exposure to anti-tumor necrosis factor (TNF) agents such that at least 50% of the randomized subjects will be anti-TNF naïve .
The study will consist of 3 phases:
- screening phase: up to 4 weeks
- double-blind placebo-controlled phase treatment: 8 weeks
- post-treatment follow-up: 2 weeks
Eligible subjects will be randomized at Week 0 (Study Day 1) to either LYC-30937-EC 25 mg or placebo. Screening will occur from Study Days -28 to -1. Randomization and first dosing will occur at Week 0/Study Day 1. Double-blind study visits will occur at Weeks 2, 4, and 8, with the last dose at Week 8/Study Day 57. Subjects will return at Week 10 for a post-treatment safety follow-up visit.
研究の種類
入学 (実際)
段階
- フェーズ2
連絡先と場所
研究場所
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Arkansas
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Little Rock、Arkansas、アメリカ、72212
- Lycera Investigational Site
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California
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Long Beach、California、アメリカ、90822
- Lycera Investigational Site
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Mission Hills、California、アメリカ、91345
- Lycera Investigational Site
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Rialto、California、アメリカ、92377
- Lycera Investigational Site
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Florida
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Hollywood、Florida、アメリカ、33021
- Lycera Investigational Site
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Miami、Florida、アメリカ、33176
- Lycera Investigational Site
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Georgia
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Decatur、Georgia、アメリカ、30033
- Lycera Investigational Site
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Marietta、Georgia、アメリカ、30060
- Lycera Investigational Site
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Illinois
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Chicago、Illinois、アメリカ、60637
- Lycera Investigational Site
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Kentucky
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Louisville、Kentucky、アメリカ、40202
- Lycera Investigational Site
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Louisiana
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Baton Rouge、Louisiana、アメリカ、70809
- Lycera Investigational Site
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Michigan
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Ann Arbor、Michigan、アメリカ、48109
- Lycera Investigational Site
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New York
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Bronx、New York、アメリカ、10461
- Lycera Investigational Site
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Brooklyn、New York、アメリカ、11230
- Lycera Investigational Site
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New York、New York、アメリカ、10024
- Lycera Investigational Site
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North Carolina
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Greenville、North Carolina、アメリカ、27834
- Lycera Investigational Site
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Pennsylvania
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Flourtown、Pennsylvania、アメリカ、19031
- Lycera Investigational Site
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Philadelphia、Pennsylvania、アメリカ、19104
- Lycera Investigational Site
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Sayre、Pennsylvania、アメリカ、18840
- Lycera Investigational Site
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Tennessee
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Nashville、Tennessee、アメリカ、37212
- Lycera Investigational Site
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Union City、Tennessee、アメリカ、38261
- Lycera Investigational Site
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Texas
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Houston、Texas、アメリカ、77030
- Lycera Investigational Site
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Houston、Texas、アメリカ、76092
- Lycera Investigational Site.
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Houston、Texas、アメリカ、77004
- Lycera Investigational Sites
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Houston、Texas、アメリカ、77004
- Lycera Investigational Site
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San Antonio、Texas、アメリカ、78229
- Lycera Investigational Site
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Amsterdam、オランダ、1081 HZ
- Lycera Investigational Site
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Rotterdam、オランダ、3015 CE
- Lycera Investigational Site
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British Columbia
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Victoria、British Columbia、カナダ、V8V 3M9
- Lycera Investigational Site
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Ontario
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Toronto、Ontario、カナダ、M5G 1X5
- Lycera Investigational Site
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Belgrade、セルビア、11000
- Lycera Investigational Site
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Belgrade、セルビア、11080
- Lycera Investigational Site
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Kragujevac、セルビア、34000
- Lycera Investigational Site
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Niš、セルビア、18000
- Lycera Investigational Site
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Subotica、セルビア、24000
- Lycera Investigational Site
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Zrenjanin、セルビア、23000
- Lycera Investigational Site
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Ostrava、チェコ、722 00
- Lycera Investigational Site
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Praha、チェコ、130 00
- Lycera Investigational Site
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Praha 3、チェコ、130 00
- Lycera Investigational Site
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Slany、チェコ、274 01
- Lycera Investigational Site
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Usti nad Labem、チェコ、401 13
- Lycera Investigational Site
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Budapest、ハンガリー、1088
- Lycera Investigational Site
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Budapest、ハンガリー、1125
- Lycera Investigational Site
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Debrecen、ハンガリー、4031
- Lycera Investigational Site
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Debrecen、ハンガリー、4032
- Lycera Investigational Site
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Hatvan、ハンガリー、3000
- Lycera Investigational Site
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Bydgoszcz、ポーランド、85-168
- Lycera Investigational Site
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Bydgoszcz、ポーランド、85-681
- Lycera Investigational Site
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Katowice、ポーランド、40-211
- Lycera Investigational Site
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Katowice、ポーランド、40-659
- Lycera Investigational Site
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Katowice、ポーランド、40-752
- Lycera Investigational Site
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Kielce、ポーランド、25 364
- Lycera Investigational Site
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Krakow、ポーランド、30-415
- Lycera Investigational Site
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Krakow、ポーランド、31-009
- Lycera Investigational Site
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Ksawerów、ポーランド、95-054
- Lycera Investigational Site
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Lublin、ポーランド、20-362
- Lycera Investigational Site
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Lublin、ポーランド、20-008
- Lycera Investigational Site
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Nowa Sól、ポーランド、67-100
- Lycera Investigational Site
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Piaseczno、ポーランド、05-500
- Lycera Investigational Site
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Poznan、ポーランド、61-113
- Lycera Investigational Site
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Skierniewice、ポーランド、96-100
- Lycera Investigational Site
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Sopot、ポーランド、81-756
- Lycera Investigational Site
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Staszów、ポーランド、28-200
- Lycera Investigational Site
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Szczecin、ポーランド、71-270
- Lycera Investigational Site
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Warszawa、ポーランド、02-507
- Lycera Investigational Site
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Warszawa、ポーランド、04-749
- Lycera Investigational Site
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Wloclawek、ポーランド、87-800
- Lycera Investigational Site
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Wroclaw、ポーランド、50-053
- Lycera Investigational Site
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Wroclaw、ポーランド、54-144
- Lycera Investigational Site
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Wrocław、ポーランド、53-333
- Lycera Investigational Site
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Wrocław、ポーランド、50-449
- Lycera Investigational Site
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Łódź、ポーランド、93-034
- Lycera Investigational Site
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Clinical UC diagnosis ≥ 6 months prior to screening with minimum disease extent of ≥ 15cm from anal verge.
- Active UC defined as a TMS of 4-11 (inclusive) with endoscopic subscore of ≥ 2 and rectal bleeding subscore of ≥ 1 at screening.
- Females of childbearing potential must have a negative pregnancy test at screening and baseline visits and must agree to use acceptable methods of birth control while in the trial and for 30 days after taking the last dose of study drug.
- May be currently receiving treatment with oral aminosalicylates (ASA) for ≥ 6 weeks at a stable dose for ≥ 3 weeks prior to the screening screening endoscopy and/or thiopurine at a stable dose ≥ 8 weeks prior to the screening endoscopy and/or prednisone (dose 20 mg daily) or equivalent for ≥ 4 weeks and receiving stable dose for ≥ 2 weeks prior to screening endoscopy
- able to provide written informed consent and be compliant with study procedures.
Exclusion Criteria:
- History of Crohn's disease (CD) or indeterminate colitis or the presence or history of fistula consistent with CD.
- Presence of colon polyps.
- Severe extensive disease that in the investigators discretion is likely to require colonic surgery during the 8 week double-blind portion of the trial (eg, fulminant colitis, toxic megacolon, bowel perforation, evidence of acute abdomen).
- History of alcohol or drug abuse within 1 year of randomization.
- History of cancer including solid tumors and hematological malignancies (except basal cell and in situ squamous cell carcinomas of the skin that have been adequately treated with no recurrence for ≥ 1 year prior to screening.
- History or currently active primary or secondary immunodeficiency.
- Clinically relevant hepatic, neurologic, pulmonary, ophthalmological, gastrointestinal, endocrine, psychiatric, or other major systemic disease making implementation of the study difficult or that would put the subject at risk by participating in the study
- Positive test for Clostridium difficile or positive stool culture for enteric pathogens or presence of ova or parasites at screening.
- Liver function tests > 1.5 x upper limit of normal (ULN) or direct bilirubin > 1.5 x ULN
- Hemoglobin < 8.5 g/dl
- Neutrophils < 1500/mm3
- White blood cell (WBC) count < 3000/mm3
- Platelets < 80000 mm3
- International normalized ratio (INR) > 1.5
- Treatment with an immunosuppressant agent within 8 weeks of screening.
- Previous exposure to ≥ 2 approved or investigational biologic agents to treat UC.
- History of UC treatment with a biologic agent within 12 weeks of screening.
- Treatment with rectal steroids within 2 weeks of screening.
- Treatment with an investigational agent within 30 days of screening.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：LYC-30937-EC 25 mg PO QD
LYC-30937-EC 25 mg by mouth once daily for 8 weeks
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プラセボコンパレーター：Placebo PO QD
Matching placebo by mouth once daily for 8 weeks
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of Subjects Who Achieve Clinical Remission at Week 8 Using Modified Mayo Score.
時間枠：8 weeks
|
The modified Mayo score is a tool designed to measure disease activity for ulcerative colitis. Scoring ranges from 0 to 9 points and consists of 3 subscores (stool frequency, rectal bleeding, endoscopy), each graded 0 to 3 with higher score indicating more severe disease activity. Endoscopy scoring was performed centrally. Clinical remission on the modified Mayo score was defined as a Mayo stool frequency subscore of ≤ 1, Mayo rectal bleeding subscore of 0 and a Mayo endoscopy subscore of ≤ 1. |
8 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of Subjects Who Achieve Clinical Remission at Week 8 Using the Total Mayo Score.
時間枠：8 weeks
|
The total Mayo score is a tool designed to measure disease activity for ulcerative colitis. Scoring ranges from 0 to 12 points and consists of 4 subscores (stool frequency, rectal bleeding, endoscopy, physicians global assessment), each graded 0 to 3 with higher score indicating more severe disease activity. Endoscopy scoring was performed centrally. Clinical remission on the total Mayo Score is defined as a total Mayo score of ≤ 2, with no individual subscore > 1. |
8 weeks
|
|
Number of Subjects With a Clinical Response on the Modified Mayo Score at Week 8.
時間枠：8 weeks
|
The modified Mayo score is a tool designed to measure disease activity for ulcerative colitis. Scoring ranges from 0 to 9 points and consists of 3 subscores (stool frequency, rectal bleeding, endoscopy), each graded 0 to 3 with higher score indicating more severe disease activity. Endoscopy scoring was performed centrally. Clinical response on the modified Mayo score at Week 8 was defined as a reduction from the baseline modified Mayo score of ≥ 2 points and ≥ 25%, and a decrease from baseline in rectal bleeding score of ≥ 1 point or absolute rectal bleeding score of ≤ 1 point. |
8 weeks
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Number of Subjects With a Clinical Response on the Total Mayo Score at Week 8.
時間枠：8 weeks
|
The total Mayo score is a tool designed to measure disease activity for ulcerative colitis. Scoring ranges from 0 to 12 points and consists of 4 subscores (stool frequency, rectal bleeding, endoscopy, physicians global assessment), each graded 0 to 3 with higher score indicating more severe disease activity. Endoscopy scoring was performed centrally. Clinical response on the total Mayo score at Week 8 was defined as a reduction from baseline total Mayo score of ≥ 3 points and ≥ 30%, and a decrease from baseline in rectal bleeding score of ≥ 1 point or absolute rectal bleeding score of ≤ 1 point. |
8 weeks
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Percent Change From Baseline to Week 8 in Fecal Calprotectin in Subjects With Baseline Fecal Calprotectin ≥ 250 µg/g
時間枠：Baseline to Week 8
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Fecal calprotectin is an indicator of inflammation in the colon with higher levels indicative of higher levels of inflammation.
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Baseline to Week 8
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Percent Change From Baseline in Total Mayo Score at Week 8.
時間枠：Baseline to Week 8
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Analyzes the change in total Mayo score score between baseline and Week 8 for all randomized subjects who had total Mayo score scores at both baseline and Week 8. The total Mayo score is a tool designed to measure disease activity for ulcerative colitis. Scoring ranges from 0 to 12 points and consists of 4 subscores (stool frequency, rectal bleeding, endoscopy, physicians global assessment), each graded 0 to 3 with higher score indicating more severe disease activity. Endoscopy scoring was performed centrally. |
Baseline to Week 8
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Number of Subjects With Type of Adverse Events (AEs) Serious Adverse Events (SAEs) and AEs That Led to Discontinuation of Treatment.
時間枠：10 weeks
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Adverse events (AEs) were collected from the time a subject signed the informed consent.
Treatment-emergent adverse events (TEAEs) are AEs occurring or worsening after the first dose of study drug (LYC-30937-EC 25 mg or placebo).
Adverse event severity was assessed by the Investigator using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v 4.03, with grading as follows: Grade 1 = mild (asymptomatic or mild symptoms), Grade 2 = moderate (minimal, local intervention, or noninvasive intervention indicated); Grade 3 = severe (or medically significant but not life-threatening); Grade 4 = life-threatening; Grade 5 = death.
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10 weeks
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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。