2024-515156-21-00
Active, not recruiting
Phase 3
C5041012 (APD334-303) - An Open-Label Extension Study of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis
Arena Pharmaceuticals Inc.60 sites in 14 countries298 target enrollmentStarted: September 24, 2024Last updated:
Overview
- Phase
- Phase 3
- Status
- Active, not recruiting
- Sponsor
- Arena Pharmaceuticals Inc.
- Enrollment
- 298
- Locations
- 60
- Primary Endpoint
- Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
Overview
Brief Summary
The primary objective is to assess the safety of long-term administration of etrasimod in subjects with moderately to severely active ulcerative colitis (UC).
Eligibility Criteria
- Ages
- 0 years to 65+ years (65+ Years, 18-64 Years, 0-17 Years)
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Must have met the eligibility criteria and have been enrolled in the qualified Phase 2 and 3 parent studies listed below or other qualified region-specific studies and meet the following additional criteria: a. Subjects previously enrolled in Study APD334-301 or APD334-210 must have either: I. Completed the Week 52 visit or II. Completed the Week 12 visit and whose UC condition in the opinion of the Investigator has not improved or has worsened, compared with baseline (Week 0/Day 1 in the parent study), provided their Endoscopic Score (ES) is ≥ 2 and they meet one of the following entry criteria: - RB sub-score ≥ 2 at 2 timepoints at least 7 days and no more than 14 days apart. - RB + SF sub-scores ≥ 4 at 2 timepoints at least 7 days and no more than 14 days apart. - RB sub-score ≥ 2 or RB + SF sub-scores ≥ 4 (in any order) at 2 timepoints at least 7 days and no more than 14 days apart. Note: For subjects discontinuing prior to Week 52, an endoscopic evaluation is required to confirm eligibility for the OLE. An endoscopy should be performed upon the appearance of UC symptoms but no more than 14 days after the second timepoint for entry criteria above. A proctosigmoidoscopy does not need to be repeated if performed within the last 4 weeks. b. Subjects previously enrolled in Study APD334-302 must have completed the Week 12 visit.
- •Eligible women of childbearing potential must fulfill the following on Week 0/Day 1: a. Have a negative urine beta-human chorionic gonadotropin (β-hCG) pregnancy test b. Not breastfeeding
- •Females must meet either a or b of the following criteria and males must meet criterion c to qualify for the study: a. A female who is not of childbearing potential must meet 1 of the following: - Postmenopausal, defined as no menses for 12 months without an alternative medical cause - Permanent sterilization procedure, such as hysterectomy, bilateral salpingectomy, or bilateral oophorectomy b. A nonpregnant female of childbearing potential must agree to using a highly effective contraception method during treatment and for 30 days following treatment that can achieve a failure rate of less than 1% per year when used consistently and correctly. The following are considered highly effective birth control methods: - Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation, which may be oral, intravaginal, or transdermal - Progestogen-only hormonal contraception associated with inhibition of ovulation, which may be oral, injected, or implanted - Intrauterine device (IUD) - Intrauterine hormone-releasing system - Bilateral tubal occlusion - Vasectomized partner, provided that partner is the sole sexual partner of the female of childbearing potential trial subject and that the vasectomized partner has received medical assessment of the surgical success - Sexual abstinence (complete sexual abstinence defined as refraining from heterosexual intercourse for the entire period of risk associated with study treatments). The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the subject. Periodic abstinence (calendar, symptothermal, post-ovulation methods) is not acceptable c. A male subject with a pregnant or nonpregnant female of childbearing potential partner must agree to using condoms during treatment and for 30 days following treatment.
- •Ability to provide written informed consent or assent (parent or legal guardian must provide consent for a subject < 18 years of age or as required per local regulations who has assented to participate in the study) and to be compliant with the schedule of protocol assessments. Enrollment of subjects < 18 years should be conducted only if acceptable according to local laws and regulations.
Exclusion Criteria
- •The Investigator considers the subject to be unsuitable for any reason to participate in the OLE study.
- •Experienced an adverse event (AE) that led to discontinuation (except when such an event is related to worsening of disease) from parent study.
- •Week 0/Day 1 pre-dose sitting vital sign assessment: heart rate (HR) < 50 bpm OR systolic BP < 90 mm Hg OR diastolic BP < 55 mm Hg.
- •Week 0/Day 1 pre-dose 12-lead electrocardiogram (ECG) in the supine position showing a second or third-degree AV block, periods of asystole > 3 seconds, PR interval > 200 ms, or Fridericia’s corrected QT interval (QTcF) ≥ 450 ms (men) or QTcF ≥ 470 ms (women).
- •Subjects requiring colectomy during the parent study.
- •Subjects requiring treatment with prohibited concomitant medications as defined in the parent study.
Outcomes
Primary Outcomes
Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
Incidence and severity of laboratory abnormalities, and change from treatment baseline in laboratory values (hematology, serum chemistry, coagulation, and urinalysis)
Incidence and severity of laboratory abnormalities, and change from treatment baseline in laboratory values (hematology, serum chemistry, coagulation, and urinalysis)
Incidence of vital sign abnormalities and changes from treatment baseline
Incidence of vital sign abnormalities and changes from treatment baseline
Secondary Outcomes
- The proportion of subjects achieving clinical remission at Weeks 52 and 104
- The proportion of subjects achieving clinical remission at Weeks 52 and 104, among subjects achieving clinical remission at study entry
- The proportion of subjects achieving clinical response at Weeks 52 and 104
- Change from baseline in the Total Mayo Score (TMS) at Weeks 52 and 104
- Change from baseline in Partial Mayo Score (PMS) at each of the following weeks: Weeks 52, 104, 156, 208, and 260
- The proportion of subjects achieving endoscopic improvement at Weeks 52 and 104
Investigators
Clinical Medical Lead
Scientific
Arena Pharmaceuticals Inc.
Study Sites (60)
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