Schedule of Activities (SoA)

This SoA applies to all stages of the adaptive study.
I7P-MC-DSAG (a) 04 Jun 2024

Schedule of Assessments
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Screening/Baseline and Induction Period

Visit 1 (Screening)

Visit interval tolerance (window) in days: ≤35

Notes: Procedures for screening (V1) may be conducted over more than 1 day as long as all activities are completed within the allowable visit tolerance. See Table 3 for activities at unscheduled visit or early discontinuation visit.

Consent, demographics, and IWRS
Physical evaluation
Patient-reported outcomes (electronic)
  • None
Clinician-administered assessments (electronic)
  • None
Clinician-administered assessments (paper)
Participant diary (electronic)
  • Dispense diary
Participant education
Laboratory tests and sample collectionsℹ
Stool test and sample collectionsℹ
Stored samplesℹ
  • None
Biopsy tests and sample collectionsℹ
  • Colonoscopy with biopsyℹ
  • Confirm infection results are negative and available before the colonoscopy
  • Confirm the patient is eligible based on the daily diary scores prior to bowel preparation
Planning Activities
  • Schedule colonoscopy to be performed within ≤14 days prior to randomization
  • Plan the randomization date with the patient
  • Review inclusion criteria #8 (dysplasia assessment to be reported locally)
Alimentiv and EDC
  • On the day the colonoscopy is performed, submit the colonoscopy video to Alimentiv
  • Complete the local read score in EDC on the same day of the colonoscopy
  • Do not change the local read score entry in EDC once entered
Signant Health – Tablet/TrialMax
  • Participant reports the normal number of stools
  • Enter the central read score into the Tablet (endoscopic findings score), complete the bowel preparation and procedure questions, and complete the eligibility requirements
  • DO NOT ACTIVATE VISIT 2 until the day of the infusion when ready to randomize the subject
  • Run the Signant Health Eligibility Report from TrialMax (making sure an IWRS code is available)
PPD Eligibility Pack Submission
  • Complete the Targeted Eligibility Documents
  • Include the TrialMax Eligibility Report
  • Submit to the PPD Medical Monitor by epip (allow 48 hrs to obtain decision)
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Visit 2 (Week 0)

Fasting Visit (See fasting instructions in Protocol Section 8.2.5)

Consent and demographics
Physical evaluation
Patient-reported outcomes (electronic)
  • Inflammatory Bowel Disease Questionnaire (IBDQ)
  • Hospital Anxiety and Depression Scale (HADS)
  • EQ-5D-5L
  • Work Productivity and Activity Impairment Questionnaire: Ulcerative Colitis (WPAI:UC)
Clinician-administered assessments (electronic)
  • Review ES, SF, and RB (UC disease activity score)
  • Physician’s Global Assessment (PGA)
Clinician-administered assessments (paper)
Participant diary (electronic)
Participant education
  • None
Laboratory tests and sample collectionsℹ
Stool test and sample collectionsℹ
  • Fecal calprotectin
Stored samplesℹ
Biopsy tests and sample collectionsℹ
  • None
Randomization and dosing-related activities
  • Only invite the patient for randomization once the patient is eligible and the IWRS code is available
  • Reminder: randomization must occur within the colonoscopy window (colonoscopy performed ≤14 days prior to randomization)
  • Register visit with IWRS
  • Randomization via IWRS (the Signant Health Eligibility Report will include an IWRS code which needs to be manually entered into IWRS by the blinded team to complete the randomization process)
  • Administer study interventionℹ
  • On the day of the infusion and randomization — Activate Visit 2 in the Tablet (do not activate before this day)
  • Package numbers corresponding to each assigned IP package number assigned by IWRS
  • Pharmacist confirms the packages in IWRS
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Visit 3 (Week 2)

Visit interval tolerance (window) in days: ±3

Consent and demographics
Physical evaluation
Patient-reported outcomes (electronic)
  • None
Clinician-administered assessments (electronic)
  • None
Clinician-administered assessments (paper)
  • None
Participant diary (electronic)
Participant education
  • None
Laboratory tests and sample collectionsℹ
Stool test and sample collectionsℹ
  • None
Stored samplesℹ
  • Exploratory biomarker samples (serum, plasma)
Biopsy tests and sample collectionsℹ
  • None
Randomization and dosing-related activities
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Visit 4 (Week 4)

Visit interval tolerance (window) in days: ±3

Consent and demographics
Physical evaluation
Patient-reported outcomes (electronic)
  • None
Clinician-administered assessments (electronic)
  • None
Clinician-administered assessments (paper)
Participant diary (electronic)
Participant education
  • None
Laboratory tests and sample collectionsℹ
Stool test and sample collectionsℹ
  • Fecal calprotectin
Stored samplesℹ
  • Exploratory biomarker samples (serum, plasma)
  • Exploratory biomarker samples (whole blood)
  • Exploratory biomarker sample (fecal [stool])
Biopsy tests and sample collectionsℹ
  • None
Randomization and dosing-related activities
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Visit 5 (Week 6)

Visit interval tolerance (window) in days: ±3

Consent and demographics
Physical evaluation
Patient-reported outcomes (electronic)
  • None
Clinician-administered assessments (electronic)
  • None
Clinician-administered assessments (paper)
  • None
Participant diary (electronic)
Participant education
  • None
Laboratory tests and sample collectionsℹ
Stool test and sample collectionsℹ
  • None
Stored samplesℹ
  • None
Biopsy tests and sample collectionsℹ
  • None
Randomization and dosing-related activities
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Visit 6 (Week 8)

Visit interval tolerance (window) in days: ±3

Consent and demographics
Physical evaluation
Patient-reported outcomes (electronic)
  • None
Clinician-administered assessments (electronic)
  • None
Clinician-administered assessments (paper)
Participant diary (electronic)
Participant education
  • None
Laboratory tests and sample collectionsℹ
Stool test and sample collectionsℹ
  • Fecal calprotectin
Stored samplesℹ
  • Exploratory biomarker samples (serum, plasma)
  • Exploratory biomarker samples (whole blood)
  • Exploratory biomarker sample (fecal [stool])
Biopsy tests and sample collectionsℹ
  • None
Randomization and dosing-related activities
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Visit 7 (Week 10)

Visit interval tolerance (window) in days: ±3

Consent and demographics
Physical evaluation
Patient-reported outcomes (electronic)
  • None
Clinician-administered assessments (electronic)
  • None
Clinician-administered assessments (paper)
  • None
Participant diary (electronic)
Participant education
Laboratory tests and sample collectionsℹ
Stool test and sample collectionsℹ
  • None
Stored samplesℹ
  • None
Biopsy tests and sample collectionsℹ
  • None
Randomization and dosing-related activities
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Visit 8 (Week 12)

Visit interval tolerance (window) in days: -7 to +14
Fasting Visit (See fasting instructions in Protocol Section 8.2.5)

Notes: Procedures for screening Week 12 (V8) may be conducted over more than 1 day as long as all activities are completed within the allowable visit tolerance. See Table 3 for activities at unscheduled visit or early discontinuation visit.

Consent and demographics
Physical evaluation
Patient-reported outcomes (electronic)
  • Patient Global Impression of Change (PGI-C)
  • Inflammatory Bowel Disease Questionnaire (IBDQ)
  • Hospital Anxiety and Depression Scale (HADS)
  • EQ-5D-5L
  • Work Productivity and Activity Impairment Questionnaire: Ulcerative Colitis (WPAI:UC)
Clinician-administered assessments (electronic)
  • Review ES, SF, and RB (UC disease activity score)
  • Physician’s Global Assessment (PGA)
Clinician-administered assessments (paper)
Participant diary (electronic)
Participant education
  • Subject to be trained on the importance of the daily diary completion
Laboratory tests and sample collectionsℹ
Stool test and sample collectionsℹ
  • Fecal calprotectin
Stored samplesℹ
Biopsy tests and sample collectionsℹ
Randomization and dosing-related activities
Planning Activities
  • Schedule colonoscopy to be performed as early as possible within the -7 to +14 day window
  • Plan Visit 8 with the patient (at least 2 different days on site required)
Alimentiv and EDC
  • On the day the colonoscopy is performed, submit the colonoscopy video to Alimentiv
  • Complete the local read score in EDC on the same day of the colonoscopy
  • Once the local read score is entered in EDC, do not change the score
Signant Health – Tablet/TrialMax
  • Enter the central read score into the Tablet (endoscopic findings score), complete the bowel preparation and procedure questions
  • DO NOT ACTIVATE VISIT 8 until the day of the infusion when ready to infuse the subject
  • Run the Signant Health Responder / Non-Responder Report from TrialMax (making sure an IWRS code is available); Please note that this IWRS code will need to be entered into IWRS to ensure study drug is dispensed

Maintenance Period

(SoA Table 2)

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Visit 9 (Week 16)

Visit interval tolerance (window) in days: ±7

Consent and demographics
Physical evaluation
Patient-reported outcomes (electronic)
  • None
Clinician-administered assessments (electronic)
  • None
Clinician-administered assessments (paper)
  • None
Participant diary (electronic)
Participant education
  • None
Laboratory tests and sample collectionsℹ
Stool test and sample collectionsℹ
  • Fecal calprotectin
Stored samplesℹ
  • Exploratory biomarker samples (serum, plasma)
  • Exploratory biomarker sample (fecal [stool])
Biopsy tests and sample collections
  • None
Randomization and dosing-related activities
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Visit 10 (Week 20)

Visit interval tolerance (window) in days: ±7

Consent and demographics
Physical evaluation
Patient-reported outcomes (electronic)
  • None
Clinician-administered assessments (electronic)
  • None
Clinician-administered assessments (paper)
Participant diary (electronic)
Participant education
  • None
Laboratory tests and sample collectionsℹ
Stool test and sample collectionsℹ
Stored samplesℹ
  • None
Biopsy tests and sample collections
  • None
Randomization and dosing-related activities
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Visit 11 (Week 24)

Visit interval tolerance (window) in days: ±7

Consent and demographics
Physical evaluation
Patient-reported outcomes (electronic)
  • Patient Global Impression of Change (PGI-C)
  • Inflammatory Bowel Disease Questionnaire (IBDQ)
  • Hospital Anxiety and Depression Scale (HADS)
  • EQ-5D-5L
  • Work Productivity and Activity Impairment Questionnaire: Ulcerative Colitis (WPAI:UC)
Clinician-administered assessments (electronic)
  • None
Clinician-administered assessments (paper)
  • None
Participant diary (electronic)
Participant education
  • None
Laboratory tests and sample collectionsℹ
Stool test and sample collectionsℹ
Stored samplesℹ
  • Exploratory biomarker samples (serum, plasma)
  • Exploratory biomarker samples (whole blood)
  • Exploratory biomarker sample (fecal [stool])
Biopsy tests and sample collections
Randomization and dosing-related activities
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Visit 12 (Week 28)

Visit interval tolerance (window) in days: ±7

Consent and demographics
Physical evaluation
Patient-reported outcomes (electronic)
  • None
Clinician-administered assessments (electronic)
  • None
Clinician-administered assessments (paper)
Participant diary (electronic)
Participant education
  • None
Laboratory tests and sample collectionsℹ
Stool test and sample collectionsℹ
Stored samplesℹ
  • Exploratory biomarker samples (serum, plasma)
Biopsy tests and sample collections
Randomization and dosing-related activities
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Visit 13 (Week 32)

Visit interval tolerance (window) in days: ±7

Consent and demographics
Physical evaluation
Patient-reported outcomes (electronic)
  • None
Clinician-administered assessments (electronic)
  • None
Clinician-administered assessments (paper)
  • None
Participant diary (electronic)
Participant education
  • None
Laboratory tests and sample collectionsℹ
Stool test and sample collectionsℹ
Stored samplesℹ
  • None
Biopsy tests and sample collections
Randomization and dosing-related activities
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Visit 14 (Week 36)

Visit interval tolerance (window) in days: ±7

Consent and demographics
Physical evaluation
Patient-reported outcomes (electronic)
  • None
Clinician-administered assessments (electronic)
  • None
Clinician-administered assessments (paper)
Participant diary (electronic)
Participant education
  • None
Laboratory tests and sample collectionsℹ
Stool test and sample collectionsℹ
Stored samplesℹ
  • Exploratory biomarker samples (serum, plasma)
  • Exploratory biomarker sample (fecal [stool])
Biopsy tests and sample collections
Randomization and dosing-related activities
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Visit 15 (Week 40)

Visit interval tolerance (window) in days: ±7

Consent and demographics
Physical evaluation
Patient-reported outcomes (electronic)
  • None
Clinician-administered assessments (electronic)
  • None
Clinician-administered assessments (paper)
  • None
Participant diary (electronic)
Participant education
  • None
Laboratory tests and sample collectionsℹ
Stool test and sample collectionsℹ
Stored samplesℹ
  • None
Biopsy tests and sample collections
Randomization and dosing-related activities
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Visit 16 (Week 44)

Visit interval tolerance (window) in days: ±7

Consent and demographics
Physical evaluation
Patient-reported outcomes (electronic)
  • None
Clinician-administered assessments (electronic)
  • None
Clinician-administered assessments (paper)
Participant diary (electronic)
Participant education
  • None
Laboratory tests and sample collectionsℹ
Stool test and sample collectionsℹ
  • None
Stored samplesℹ
  • Exploratory biomarker samples (serum, plasma)
Biopsy tests and sample collections
  • None
Randomization and dosing-related activities
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Visit 17 (Week 48)

Visit interval tolerance (window) in days: ±7

Consent and demographics
Physical evaluation
Patient-reported outcomes (electronic)
  • None
Clinician-administered assessments (electronic)
  • None
Clinician-administered assessments (paper)
  • None
Participant diary (electronic)
Participant education
Laboratory tests and sample collectionsℹ
Stool test and sample collectionsℹ
  • None
Stored samplesℹ
  • None
Biopsy tests and sample collections
  • None
Randomization and dosing-related activities
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Visit 18 (Week 52)

Visit interval tolerance (window) in days: ±7
Fasting Visit (See fasting instructions in Protocol Section 8.2.5)

Notes: Procedures for Week 52 (V18) may be conducted over more than 1 day as long as all activities are completed within the allowable visit tolerance. See Table 3 for activities at unscheduled visit or early discontinuation visit.

Consent and demographics
Physical evaluation
Patient-reported outcomes (electronic)
  • Patient Global Impression of Change (PGI-C)
  • Inflammatory Bowel Disease Questionnaire (IBDQ)
  • Hospital Anxiety and Depression Scale (HADS)
  • EQ-5D-5L
  • Work Productivity and Activity Impairment Questionnaire: Ulcerative Colitis (WPAI:UC)
Clinician-administered assessments (electronic)
  • Review ES, SF, and RB (UC disease activity score)
  • Physician’s Global Assessment (PGA)
Clinician-administered assessments (paper)
Participant diary (electronic)
Participant education
  • None
Laboratory tests and sample collectionsℹ
Stool test and sample collectionsℹ
  • Fecal calprotectin
Stored samplesℹ
Biopsy tests and sample collections
Randomization and dosing-related activities
  • Register visit with IWRS
Signant Health – Tablet/TrialMax
  • Enter the central read score into the Tablet (endoscopic findings score), complete the bowel preparation and procedure questions

Follow-up Period, Early Discontinuation Visit, and Unscheduled Visit (SoA Table 3)

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Visit 801 (Week 56)

8 weeks after last dose. Follow-up visits are required for all randomly assigned participants.
Visit interval tolerance (window) in days: ±7

Consent and demographics
Physical evaluation
Patient-reported outcomes (electronic)
  • None
Clinician-administered assessments (electronic)
  • None
Clinician-administered assessments (paper)
  • None
Participant diary (electronic)
Laboratory tests and sample collections
  • Hematology
  • Clinical chemistry
Stool test and sample collections
  • None
Stored samples
  • None
Biopsy tests and sample collections
  • None
Randomization and dosing-related activities
  • Register visit with IWRS
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Visit 802 (Week 64)

16 weeks after last dose. Follow-up visits are required for all randomly assigned participants.
Visit interval tolerance (window) in days: ±7

Consent and demographics
Physical evaluation
Patient-reported outcomes (electronic)
  • Inflammatory Bowel Disease Questionnaire (IBDQ)
Clinician-administered assessments (electronic)
  • None
Clinician-administered assessments (paper)
Participant diary (electronic)
Laboratory tests and sample collections
Stool test and sample collections
  • None
Stored samples
  • None
Biopsy tests and sample collections
  • None
Randomization and dosing-related activities
  • Register visit with IWRS
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Early Discontinuation Visit (EDV)

Consent and demographics
Physical evaluation
Patient-reported outcomes (electronic)
  • Patient Global Impression of Change (PGI-C)
  • Inflammatory Bowel Disease Questionnaire (IBDQ)
  • Hospital Anxiety and Depression Scale (HADS)
  • EQ-5D-5L
  • Work Productivity and Activity Impairment Questionnaire: Ulcerative Colitis (WPAI:UC)
Clinician-administered assessments (electronic)
  • Review SF, RB, and ES (UC disease activity score)
  • Physician’s Global Assessment (PGA)
Clinician-administered assessments (paper)
Participant diary (electronic)
Laboratory tests and sample collections
Stool test and sample collections
  • Fecal calprotectin
Stored samples
Biopsy tests and sample collections
Randomization and dosing-related activities
  • Register visit with IWRS
Signant Health – Tablet/TrialMax
  • Enter the central read score into the Tablet (endoscopic findings score), complete the bowel preparation and procedure questions
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Unscheduled Visit (UV)

Consent and demographics
Physical evaluation
Patient-reported outcomes (electronic)
  • None
Clinician-administered assessments (electronic)
Clinician-administered assessments (paper)
  • None
Participant diary (electronic)
  • None
Laboratory tests and sample collections
  • None
Stool test and sample collections
  • None
Stored samples
  • None
Biopsy tests and sample collections
Randomization and dosing-related activities
  • None
Signant Health – Tablet/TrialMax
  • Enter the central read score into the Tablet (endoscopic findings score), complete the bowel preparation and procedure questions

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