A Phase 4 Study Evaluating Moderate to Severely Active Ulcerative Colitis or Crohn's Disease and the Use of Vedolizumab Subcutaneous Within a Community Setting
概览
- 阶段
- 4 期
- 干预措施
- Vedolizumab IV
- 疾病 / 适应症
- Ulcerative Colitis
- 发起方
- Takeda
- 入组人数
- 400
- 试验地点
- 167
- 主要终点
- Percentage of CD Participants With 2-item Patient-reported Outcome Measure (PRO-2) Remission at Week 14
- 状态
- 招募中
- 最后更新
- 10天前
概览
简要总结
Ulcerative Colitis (UC) and Crohn's Disease (CD) are long-term conditions in the gut that can cause diarrhea, swelling (inflammation), bleeding from the anus, and belly pain. The main aim of this study is to check for how many participants with UC and CD signs and symptoms disappear after 3.5 months (14 weeks) of treatment with Vedolizumab (this is called remission).
Participants will be treated with Vedolizumab for approximately 1 year (50 weeks). During the first 1.5 months (6 weeks), participants will receive Vedolizumab as an infusion in the vein (called intravenously). After this, participants will receive Vedolizumab as an injection under the skin (called subcutaneously) for the rest of the treatment. Participants for whom the treatment does not seem to work well after 3.5 months (14 weeks) will stop treatment with Vedolizumab and can change to another treatment and also there will be additional required visits at 6 months (26 weeks) and at 1 year (52 weeks). All participants will be checked again 4.5 months (18 weeks) after their last treatment with Vedolizumab.
During the study, participants will visit their study clinic several times.
研究者
入排标准
入选标准
- •To be eligible to participate in this study, participants must meet all the following criteria:
- •In the investigator's opinion, the participant can understand and comply with protocol requirements.
- •The participant signs and dates an electronic informed consent form (ICF) and any required privacy authorization prior to any study procedures.
- •The participant is 18 to 80 years of age at the time of signing the ICF.
- •The participant's immunization is up to date per vedolizumab US prescribing information (USPI).
- •If participant is a woman of childbearing potential (WOCBP):
- •Agrees to use at least 1 form of highly effective contraception from signing the ICF until at least 18 weeks after the last dose of vedolizumab.
- •Agrees to avoid donating ova from signing the ICF throughout the duration of the study and for 18 weeks after the last dose of vedolizumab.
- •Has a negative urine pregnancy test within 3 days before first dose of vedolizumab.
- •Agrees to forego breastfeeding from first dose of vedolizumab through 18 weeks after the last dose of vedolizumab.
排除标准
- •Participants who meet any of the following exclusion criteria will be excluded from participation in this study:
- •Received approved or investigational anti-integrin antibodies (i.e., vedolizumab, natalizumab, efalizumab, etrolizumab, abrilumab \[AMG 181\]) at any time prior to screening.
- •Failed (primary or secondary nonresponse) on more than 2 prior advanced treatments.
- •Use of corticosteroid enemas/suppositories within 2 weeks prior to screening (for UC and CD).
- •In the investigator's opinion the participant meets any contraindication, warnings and precautions, drug interactions, or special population considerations per the vedolizumab USPI, or has (medical history or known allergy, hypersensitivity, or intolerance to vedolizumab or its excipients) (Food and Drug administration \[FDA\] 2024).
- •Received any investigational biologic therapy \<= 6 months prior to screening.
- •The participant has received an advanced treatment for an approved indication other than CD or UC. Advanced therapy include: TNF inhibitors (e.g. infliximab, adalimumab, certolizumab pegol), and IL 12/23 antagonist (e.g. ustekinumab, mirikizumab, risankizumab); and small molecules include JAK inhibitor (e.g. tofacitinib, upadacitinib) and sphingosine-1-phosphate (S1P) receptor modulator (e.g. etrasimod, ozanimod).
- •The participant has any evidence of an active infection during screening.
- •Ileostomy, colostomy, severe, or symptomatic stenosis of the intestine or short bowel syndrome.
- •A surgical procedure requiring general anesthesia within 3 months prior to screening or is planning to or is at risk of undergoing major surgery during the study period.
研究组 & 干预措施
UC Participants: Vedolizumab
Participants with moderate to severely active UC will receive vedolizumab 300 milligrams (mg), intravenous (IV) infusion at Weeks 0 and 2. Following the first 2 vedolizumab IV doses, participant may be switched to vedolizumab 108 mg subcutaneous (SC) injection at Week 6, to be administered every 2 weeks until Week 50. Treating health care practitioner (HCP) may give an additional dose of vedolizumab IV at Week 6 with mandatory transition by Week 14.
干预措施: Vedolizumab IV
UC Participants: Vedolizumab
Participants with moderate to severely active UC will receive vedolizumab 300 milligrams (mg), intravenous (IV) infusion at Weeks 0 and 2. Following the first 2 vedolizumab IV doses, participant may be switched to vedolizumab 108 mg subcutaneous (SC) injection at Week 6, to be administered every 2 weeks until Week 50. Treating health care practitioner (HCP) may give an additional dose of vedolizumab IV at Week 6 with mandatory transition by Week 14.
干预措施: Vedolizumab SC
CD Participants: Vedolizumab
Participants with moderate to severely active CD will receive vedolizumab 300 mg, IV infusion at Weeks 0 and 2. Following the first 2 vedolizumab IV doses, participant may be switched to vedolizumab 108 mg SC injection at Week 6, to be administered every 2 weeks until Week 50. Treating HCP may give an additional dose of vedolizumab IV at Week 6 with mandatory transition by Week 14.
干预措施: Vedolizumab IV
CD Participants: Vedolizumab
Participants with moderate to severely active CD will receive vedolizumab 300 mg, IV infusion at Weeks 0 and 2. Following the first 2 vedolizumab IV doses, participant may be switched to vedolizumab 108 mg SC injection at Week 6, to be administered every 2 weeks until Week 50. Treating HCP may give an additional dose of vedolizumab IV at Week 6 with mandatory transition by Week 14.
干预措施: Vedolizumab SC
结局指标
主要结局
Percentage of CD Participants With 2-item Patient-reported Outcome Measure (PRO-2) Remission at Week 14
时间窗: At Week 14
PRO-2 remission is defined as 7-day average of very soft or liquid stool frequency (SF) less than and equal to (\<=) 2.8, 7-day average of abdominal pain (AP) score \<= 1.0, and neither worse than baseline.
Percentage of UC Participants With PRO-2 Remission at Week 14
时间窗: At Week 14
PRO-2 remission is defined as Mayo rectal bleeding sub-score of 0 and stool frequency sub-score \<=1.
次要结局
- Percentage of CD and UC Participants With PRO-2 Remission at Weeks 6 and 52(At Weeks 6 and 52)
- Percentage of CD and UC Participants With Clinical Response at Weeks 6, 14, and 52(At Weeks 6, 14, and 52)
- Percentage of CD Participants With Endoscopic Response at Week 52(At Week 52)
- Percentage of CD Participants Achieving Endoscopic Remission at Week 52(At Week 52)
- Percentage of UC Participants With Improvement of Endoscopic Appearance of the Mucosa at Week 52(At Week 52)
- Percentage of UC Participants With Endoscopic Remission at Week 52(At Week 52)
- Percentage of CD and UC Participants With Clinical Remission at Weeks 6, 14, and 52(At Weeks 6, 14, and 52)
- Percentage of CD and UC Participants With Clinical Remission at Week 52(At Week 52)
- Change From Baseline in C-reactive Protein (CRP) levels of CD and UC Participants at Weeks 6, 14, and 52(Baseline, Weeks 6, 14, and 52)
- Change From Baseline in Fecal Calprotectin Concentrations of CD and UC participants at Weeks 6, 14, and 52(Baseline, Weeks 6, 14, and 52)
- Number of CD and UC Participants With Serious Infections(Up to end of study (up to 72 weeks))