Clinical Agent

💡

How to use the Clinion Agent

🔬 Study at a Glance

Drug: ADL-018 (omalizumab biosimilar) vs Xolair

Phase: Phase 3 – Biosimilar + Interchangeability

Design: 4-Arm, Parallel, DB, Active-Controlled

Ratio: 2:2:1:1 (ADL-018 300mg : Xolair 300mg : ADL-018 150mg : Xolair 150mg)

Subjects: ~600 randomized

Duration: 42 weeks (Screening → Follow-up)

Population: Adults 18–75, CIU refractory to H1 antihistamines

Sites: Multicenter (India ≥80%, US, Europe)

🎯 Primary Endpoints

Change from baseline in weekly Itch Severity Score (ISS7) at Week 12:
• ADL-018 300 mg vs Xolair 300 mg — confirmatory biosimilarity
• Relative potency via 4-point assay (FDA co-primary) using both 150 mg & 300 mg
BE criteria: 90% CI within [−2.5, +2.0] (ADL-018 vs Xolair, FDA); 95% CI for other agencies

📅 Visit Schedule

Visit	Day / Week	Type
Visit 1	Day −14 / Week −2	Screening – Consent, Med Hx, Demographics, Serology, Vitals, Labs, Diary Dispensing, I/E Criteria, Physician UAS
Visit 2	Day −7 / Week −1	Screening – Diary Review, I/E Criteria, Physician UAS
Visit 3	Day 1 / Week 0	Baseline / Randomization – DLQI, Randomization, PK/PD/ADA, IP Admin, ISE, Labs, IP Kit Allocation
Visit 4	Day 29 ±3 / Week 4	On-treatment – DLQI, PK/PD/ADA, IP Admin, Vitals, ISE, Physical Exam, Diary
Visit 5	Day 57 ±3 / Week 8	On-treatment – DLQI, PK/PD, IP Admin, Vitals, ISE, Physical Exam, Diary
Visit 6	Day 85 / Week 12	Primary Endpoint – DLQI, PK/PD/ADA, IP Admin, ISE, Bicarbonate, IP Kit, Re-Randomization, Full Labs
Visit 7	Day 113 ±3 / Week 16	Switching Period – DLQI, PK/PD, IP Admin, Vitals, ISE, Physical Exam, Diary
Visit 8	Day 141 ±3 / Week 20	Switching Period – DLQI, PK/PD, IP Admin, Vitals, ISE, Physical Exam, Diary
Visit 9	Day 169 ±3 / Week 24	End of Switching – DLQI, PK/PD/ADA, ISE, Bicarbonate, Physician UAS, Full Labs
Visit 10	Day 197 ±3 / Week 28	Follow-up – PK/PD, Vitals, Physical Exam, Diary Review & Dispensing
Visit 11	Day 225 ±3 / Week 32	Follow-up – PK/PD, Vitals, Physical Exam, Diary Review & Dispensing
Visit 12	Day 253 ±3 / Week 36	Follow-up – PK/PD, Vitals, Physical Exam, Diary Review & Dispensing
Visit 13	Day 281 ±3 / Week 40	End of Study – PK/PD/ADA, Bicarbonate, Physical Exam, Diary Review, Full Labs
General Forms	Ongoing	AEs, Concomitant Meds, H1 Antihistamine, Rescue Medication, Surgery/Procedure, Weekly UAS Score, Unblinding
Unscheduled	As needed	Unscheduled Vitals, Physical Exam, Pregnancy, DLQI, Serology, PK/PD/ADA, ISE, IP Admin, Labs, Patient Characteristics
Early DC	If applicable	DLQI, PK/PD/ADA, IP Admin, ISE, Bicarbonate, Physical Exam, Diary Review, Full Labs
End of Study	After V13	Study Completion – completion/discontinuation status, date, reason for early exit

👥 Analysis Populations

• ITT: All randomized subjects satisfying eligibility with ≥1 dose
• Per Protocol: ITT subjects with no important deviations affecting Week 12 efficacy
• Safety: All subjects receiving ≥1 dose, analyzed by treatment received
• PK Population: ≥1 dose + ≥1 post-treatment PK result before Week 12
• ITT Switch / Safety Switch: Randomized and dosed during Switching Period
• Evaluable Switching: All 3 switches completed + adequate PK/PD profiles

💡 Click any question to copy it — then paste directly into the chat.

📋 Protocol

Which adverse events are classified as protocol-defined safety endpoints?

What are the dose modification criteria and stopping rules defined in the protocol?

Plot the planned timing of study visits from Screening through End of Study.

Explain the switching design in this study.

Which visits are part of screening versus treatment period?

What are the key inclusion criteria for patient enrollment?

⚙️ Operational

Show all subjects with pages not yet SDV completed, grouped by site.

Which CRF pages have the highest number of edits in the audit log and what fields changed most?

Which sites are behind on visit reconciliation?

List subjects who are soft-locked but still have unsubmitted pages.

What is the required visit schedule for the Vital Signs form across all study phases?

Plot the monthly trend of data queries by study site.

List subjects who discontinued early and their reasons by site.

Identify data quality issues across visits and CRFs.

🩺 Clinical

Which subjects skipped the Bicarbonate panel at Visit 1, Visit 6, or Visit 13?

Show subjects with no Weekly UAS Score entries for more than 2 consecutive weeks.

Show all subjects where Visit 3 Randomization page is submitted but H1 Antihistamine Treatment form is missing.

How many subjects achieved complete response (UAS7 = 0) or controlled disease (UAS7 ≤ 6) at Week 12?

Show subjects with missing ISS7 values in CRFs at any visit.

Analyze the distribution of AE and SAE events by gender.

Show the full patient journey from screening to study completion.

📄 35 CRF panels across 6 sections. Click any section to expand.

📁 1 · Screening & Baseline (V1–V3) ▼

Date of Visit

Visit date, whether assessments were performed, and reason if not done. Appears on every scheduled visit (Pnl1_SV).

Informed Consent

Consent obtained flag and date of informed consent. Collected at Visit 1 (Pnl8_DS1). Required before any study procedure.

Medical/Surgical History

Whether history exists to report; then per-condition: reported term, start date, ongoing flag, end date, medications or therapies taken. Collected at Visit 1 (Pnl2_MH1, Pnl3_MH2).

Demographics

Date of birth, age, gender, female child-bearing status, race, ethnicity. Visit 1 only (Pnl6_DM).

Subject Characteristics

Weight, height, BMI — collected at Visit 1 (Pnl35_SC).

Serology Test

HIV, Hepatitis B, Hepatitis C results with specimen date. Visit 1 only (Pnl7_LB1).

Inclusion & Exclusion Criteria

All 6 inclusion items (consent capability, age 18–60, CIU ≥8 wks refractory, UAS criteria, diary compliance, contraception) and 20 exclusion items answered Yes/No/NA. Collected V1, V2, V3 (Pnl85_IE3).

Randomization

Randomized flag, reason if not, date of randomization. Visit 3 (Pnl13_DS2).

Re-Randomization

Re-randomized flag, reason if not, date. Visit 6 (Week 12) only — for Xolair 300 mg arm entering switching period (Pnl77_DS3).

📁 2 · Efficacy Assessments ▼

Physician UAS Score

In-clinic assessment: Itch Severity Score (ISS), Hives Score (HS), and composite UAS. Captured at Visits 1–9 and Early DC (Pnl86_UASC).

0 — None 1 — Mild 2 — Moderate 3 — Intense

Weekly UAS Score

Diary-derived weekly scores from Week −2 through Week 24 (Weeks −2, −1, 1–24). Each week: start date, stop date, weekly ISS, weekly Hives Score, weekly UAS. Primary endpoint uses Week 12 ISS7. Captured in General Forms (Pnl87_UAS1).

DLQI

10-question Dermatology Life Quality Index. Collected at Visits 3–9 and Early DC (if within period). Each question scored 0–3; total DLQI score computed (Pnl12_DLQI).

Patient Diary Review

Whether diary was reviewed by site staff, reason if not, review date. Collected at Visits 2–13 and Early DC (Pnl83_PD2).

Patient Diary Dispensing

Whether diary was dispensed, reason if not, dispensing date. Collected at Visits 1, 3–12 (Pnl84_PD1).

📁 3 · Safety & Vitals ▼

Adverse Events

AE term, SAE flag, seriousness criteria (death, life-threatening, hospitalization, disability, congenital anomaly), severity (Mild/Moderate/Severe/Life-threatening/Death), causality (Certain → Not Related), action on drug, outcome, medication taken, AESI flag, IP dosing flag. General Forms (Pnl18_AE, Pnl19_AE3).

Vital Signs

Temperature, Pulse Rate, Respiratory Rate, Systolic BP, Diastolic BP — each with result and Normal/Abnormal-CS/Abnormal-NCS interpretation. Collected V1–V13 and Early DC (Pnl28_VS).

Physical Examination

Multi-system exam: General Appearance, ENT, Eyes, Respiratory, Cardiovascular, CNS, GI, Skin, Musculoskeletal, Other. Each system: Normal / Abnormal-CS / Abnormal-NCS with free-text for CS findings. V1–V13 and Early DC (Pnl81_PE).

Injection Site Evaluation

Assessment performed flag, date/time, signs observed flag, sign type(s). Signs:

Bruising Redness Warmth Burning Stinging Itching Hive Formation Pain Indurations Mass Inflammation

Collected V3–V9 and Early DC (Pnl31_ISE).

Urine Pregnancy Test

Specimen collected flag, reason if not, date, Positive/Negative result. If positive: serum pregnancy test (lab name, date, serum result). Collected V1, V3–V13 and Early DC (Pnl9_LB2).

📁 4 · Laboratory Assessments ▼

Hematology

Lab performed flag, specimen date, lab name (Sterling Accuris India / ACM Global US / Other). Parameters: Hemoglobin, Hematocrit, Platelet, RBC, WBC, Neutrophils, Eosinophils, Lymphocytes, Monocytes, Basophils, Bands, and absolute counts for each — each with result and Normal/Abnormal-CS/NCS outcome. V1, V3, V6, V9, V13, Early DC (Pnl88_LB3).

Biochemistry

Same visit schedule as Hematology. Parameters: Na, K, Cl, Glucose, BUN, Creatinine, Ca, Phosphorus, Mg, Total & Direct Bilirubin, Total Protein, Albumin, ALT, AST, LDH, Alkaline Phosphatase, CPK, Uric Acid — each with result and outcome (Pnl89_LB4).

Urinalysis

Same visit schedule. Parameters: Protein, Glucose, Nitrites, Specific Gravity, Ketones, RBCs, WBCs, Pus Cells, Microorganisms, Crystals, Casts, Red Cells, Epithelial Cells — each with result and outcome (Pnl90_LB5).

Bicarbonate

Bicarbonate result, unit, reference range, and outcome (Normal/Abnormal-CS/NCS). Collected at V1, V3, V6, V9, V13 and Early DC (Pnl36_LB6).

📁 5 · IP Administration & Biosampling ▼

IP Administration

IP administered flag, reason if not, date/time of dose, injection site (Deltoid / Thigh), per-protocol flag with explanation if no. Collected V3–V9 (Pnl17_IP2).

IP Kit Allocation

Kit allocated flag, reason if not, allocation date, kit number. Collected at V3 (baseline) and V6 (re-randomization) (Pnl76_KA).

PK Sample Collection

Sample collected flag, reason if not, date and time of collection. Collected V3–V13 and Early DC (Pnl14_PK).

PD Sample Collection

Sample collected flag, reason if not, date and time. Total and free IgE measurements. Collected V3–V13 and Early DC (Pnl15_PD).

ADA Testing

ADA sample collected flag, reason if not, date and time. Anti-drug antibody assessment for immunogenicity. Collected at V3, V4, V6, V9, V13 and Early DC (Pnl16_ADAT).

📁 6 · Medications, General Forms & Closeout ▼

Prior & Concomitant Medication

Medication name, prior-med flag, indication code (Medical History / AE / Prophylactic), indication free-text, dose, unit, frequency, route, start date, ongoing/end date. General Forms (Pnl20_CM, Pnl21_CM2).

H1 Antihistamine Treatment

H1 treatment given flag; medicine name (Cetirizine, Levocetirizine, Fexofenadine, Desloratadine, Loratadine), dose, frequency, dosage form, start/stop dates, dose missed flag and count. General Forms (Pnl62_AT, Pnl63_AT2).

Rescue Medication

Rescue medication taken flag; name (Diphenhydramine), dose (25 mg), dosing date and time. General Forms (Pnl74_RMED, Pnl75_RMED2).

Surgery / Medical Procedure

Procedure name, reason, start date, ongoing at final exam, end date. General Forms (Pnl22_SMP, Pnl23_SMP2).

Unblinding

Whether unblinding occurred, reason (Accidental / AE-SAE related / Other), date. General Forms (Pnl26_EU).

Study Completion

Study completed flag; if no: primary reason for early discontinuation (AE, Death, Lack of Efficacy, Non-compliance, LTFU, Protocol Criteria, Sponsor Decision, Patient Withdrawal, Pregnancy, Protocol Deviation, Physician Decision, Screen Failure, Other), date, reason for death, autopsy flag. End of Study form (Pnl27_DS5).

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