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A Dose Finding, Efficacy and Safety Study of Ensovibep (MP0420) in Ambulatory Adult Patients With Symptomatic COVID-19 (EMPATHY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04828161
Recruitment Status : Terminated (Phase 2 completed as planned. Due to the evolving landscape of treatments for COVID-19, the placebo-controlled Phase 3 design will not proceed. No patients were actively participating at the time of termination.)
First Posted : April 1, 2021
Results First Posted : January 18, 2023
Last Update Posted : January 18, 2023
Sponsor:
Collaborator:
Molecular Partners AG
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Tracking Information
First Submitted Date  ICMJE March 24, 2021
First Posted Date  ICMJE April 1, 2021
Results First Submitted Date  ICMJE November 14, 2022
Results First Posted Date  ICMJE January 18, 2023
Last Update Posted Date January 18, 2023
Actual Study Start Date  ICMJE May 10, 2021
Actual Primary Completion Date November 18, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 21, 2022)
  • Part A: Time-Weighted Change From Baseline in Log10 Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load Through Day 8 [ Time Frame: Baseline (Day 1) and Days 3, 5 and 8 ]
    The SARS-CoV-2 viral load was measured by means of a nasopharyngeal swab, followed by quantitative reverse transcription-polymerase chain reaction assay at a central laboratory. The multiple comparison procedure-modeling methodology was used. Time-weighted change from baseline was used as viral loads were measured at multiple time points.
  • Part B: Percentage of Participants With Hospitalizations and/or Emergency Room (ER) Visits Related to COVID-19 or Death From Any Cause [ Time Frame: Up to Day 29 ]
    Percentage of participants experiencing hospitalizations [>= 24 hour (h) of acute care] and/or ER visits related to COVID-19 or death from any cause up to Day 29.
Original Primary Outcome Measures  ICMJE
 (submitted: March 30, 2021)
  • Part A - SARS-CoV-2 viral load [ Time Frame: 8 days (days 0, 3, 5 and 8) ]
    Time-weighted change from baseline (measured at Day 3, Day 5, and Day 8) in SARS-CoV-2 viral load in nasopharyngeal swabs through Day 8
  • Part B - Occurrence of hospitalizations, emergency room visits or death [ Time Frame: up to day 29 ]
    Proportion of patients experiencing hospitalizations (≥ 24 hours of acute care) and/or emergency room visits related to COVID-19 or death from any cause up to Day 29.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 21, 2022)
  • Part A: Percentage of Participants With Hospitalizations and/or ER Visits Related to COVID-19 or Death From Any Cause [ Time Frame: Up to Day 29 ]
    Percentage of participants experiencing hospitalizations (>= 24 h of acute care) and/or ER visits related to COVID-19 or death from any cause up to Day 29 were presented along with relative risk to placebo.
  • Part A: Time to Sustained Clinical Recovery [ Time Frame: Up to Day 29 ]
    Sustained clinical recovery was defined as follows;
    1. All symptoms from the modified Food and Drug Administration (FDA) COVID-19 questionnaire scored as moderate or severe at baseline were subsequently scored as mild or absent, and
    2. All symptoms from the modified FDA COVID-19 questionnaire scored as mild or absent at baseline were subsequently scored as absent, with no subsequent worsening, up to Day 29.
  • Part A: Observed Maximum Serum Concentration (Cmax) of Total and Free Ensovibep [ Time Frame: Data was summarized from pre-dose and at 15 minutes and 90 minutes after end of study drug infusion on Day 1, and at Days 3, 8, 15, 29, 61 and 91 ]
    Blood samples were collected to determine the Cmax of free ensovibep (ensovibep not bound to target) and total ensovibep (sum of ensovibep not bound to and bound to target) concentrations in serum.
  • Part A: Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Total and Free Ensovibep [ Time Frame: Data was summarized from pre-dose and at 15 minutes and 90 minutes after end of study drug infusion on Day 1, and at Days 3, 8, 15, 29, 61 and 91 ]
    Blood samples were collected to determine the AUClast of free ensovibep (ensovibep not bound to target) and total ensovibep (sum of ensovibep not bound to and bound to target) concentrations in serum.
  • Part A: Area Under the Concentration-Time Curve From Time Zero to 48 Hours (AUC 0-48h) of Total and Free Ensovibep [ Time Frame: Data was summarized from pre-dose and at 15 minutes and 90 minutes after end of study drug infusion on Day 1, and at Day 3 ]
    Blood samples were collected to determine the AUC 0-48h of free ensovibep (ensovibep not bound to target) and total ensovibep (sum of ensovibep not bound to and bound to target) concentrations in serum.
  • Part A: Area Under the Concentration-Time Curve From Time Zero to 168 Hours (AUC 0-168h) of Total and Free Ensovibep [ Time Frame: Data was summarized from pre-dose and at 15 minutes and 90 minutes after end of study drug infusion on Day 1, and at Days 3 and 8 ]
    Blood samples were collected to determine the AUC 0-168h of free ensovibep (ensovibep not bound to target) and total ensovibep (sum of ensovibep not bound to and bound to target) concentrations in serum.
  • Part A: Area Under the Concentration-Time Curve From Time Zero to 336 Hours (AUC 0-336h) of Total and Free Ensovibep [ Time Frame: Data was summarized from pre-dose and at 15 minutes and 90 minutes after end of study drug infusion on Day 1, and at Days 3, 8 and 15 ]
    Blood samples were collected to determine the AUC 0-336h of free ensovibep (ensovibep not bound to target) and total ensovibep (sum of ensovibep not bound to and bound to target) concentrations in serum.
  • Part A: Area Under the Concentration-Time Curve From Time Zero to Infinity (AUCinfinity) of Total and Free Ensovibep [ Time Frame: Data was summarized from pre-dose and at 15 minutes and 90 minutes after end of study drug infusion on Day 1, and at Days 3, 8, 15, 29, 61 and 91 ]
    Blood samples were collected to determine the AUCinfinity of free ensovibep (ensovibep not bound to target) and total ensovibep (sum of ensovibep not bound to and bound to target) concentrations in serum.
  • Part A: Time to Reach the Maximum Concentration (Tmax) of Total and Free Ensovibep [ Time Frame: Data was summarized from pre-dose and at 15 minutes and 90 minutes after end of study drug infusion on Day 1, and at Days 3, 8, 15, 29, 61 and 91 ]
    Blood samples were collected to determine the Tmax of free ensovibep (ensovibep not bound to target) and total ensovibep (sum of ensovibep not bound to and bound to target) concentrations in serum.
  • Part A: Apparent Total Body Clearance (CL) of Total and Free Ensovibep [ Time Frame: Data was summarized from pre-dose and at 15 minutes and 90 minutes after end of study drug infusion on Day 1, and at Days 3, 8, 15, 29, 61 and 91 ]
    Blood samples were collected to determine the CL of free ensovibep (ensovibep not bound to target) and total ensovibep (sum of ensovibep not bound to and bound to target) concentrations in serum.
  • Part A: Terminal Elimination Rate Constant (Lambda z) of Total and Free Ensovibep [ Time Frame: Data was summarized from pre-dose and at 15 minutes and 90 minutes after end of study drug infusion on Day 1, and at Days 3, 8, 15, 29, 61 and 91 ]
    Blood samples were collected to determine the lambda z of free ensovibep (ensovibep not bound to target) and total ensovibep (sum of ensovibep not bound to and bound to target) concentrations in serum.
  • Part A: Terminal Elimination Half-Life (T1/2) of Total and Free Ensovibep [ Time Frame: Data was summarized from pre-dose and at 15 minutes and 90 minutes after end of study drug infusion on Day 1, and at Days 3, 8, 15, 29, 61 and 91 ]
    Blood samples were collected to determine the T1/2 of free ensovibep (ensovibep not bound to target) and total ensovibep (sum of ensovibep not bound to and bound to target) concentrations in serum.
  • Part A: Apparent Volume of Distribution (Vz) of Total and Free Ensovibep [ Time Frame: Data was summarized from pre-dose and at 15 minutes and 90 minutes after end of study drug infusion on Day 1, and at Days 3, 8, 15, 29, 61 and 91 ]
    Blood samples were collected to determine the Vz of free ensovibep (ensovibep not bound to target) and total ensovibep (sum of ensovibep not bound to and bound to target) concentrations in serum.
  • Part B: Change From Baseline in Log10 SARS-CoV-2 Viral Load Through Day 8 [ Time Frame: Baseline (Day 1) and Days 3, 5 and 8 ]
    The SARS-CoV-2 viral load was measured by means of a nasopharyngeal swab, followed by quantitative reverse transcription-polymerase chain reaction assay at a central laboratory. The multiple comparison procedure-modeling methodology was used.
  • Part B: Time to Sustained Clinical Recovery [ Time Frame: Up to Day 29 ]
    Sustained clinical recovery was defined as follows;
    1. All symptoms from the modified FDA COVID-19 questionnaire scored as moderate or severe at baseline were subsequently scored as mild or absent, and
    2. All symptoms from the modified FDA COVID-19 questionnaire scored as mild or absent at baseline were subsequently scored as absent, with no subsequent worsening, up to Day 29.
  • Part B: Percentage of Participants With Treatment-Emergent Anti-Drug Antibody (ADA) Response to Ensovibep [ Time Frame: Pre-dose on Day 1 and Days 15, 29, 61 and 91 postdose of Ensovibep ]
    Treatment-emergent ADA is defined as any participant with a
    1. 2-fold (1 dilution) increase in titer than the minimum required dilution if no ADAs were detected at baseline (treatment-induced ADA); or,
    2. 4-fold (2 dilutions) increase in titer compared with baseline if ADAs were detected at baseline (treatment-boosted ADA).
Original Secondary Outcome Measures  ICMJE
 (submitted: March 30, 2021)
  • Part A - Occurrence of hospitalizations, emergency room visits or death [ Time Frame: up to day 29 ]
    Proportion of patients experiencing hospitalizations (≥ 24 hours of acute care) and/or emergency room visits related to COVID-19 or death from any cause up to Day 29.
  • Part A - Time to sustained clinical recovery [ Time Frame: up to day 29 ]
    Time to sustained clinical recovery, defined as (a) all symptoms from the modified FDA COVID-19 symptom list scored as moderate or severe at baseline are subsequently scored as mild or absent, AND (b) all symptoms from the modified FDA COVID-19 symptom list scored as mild or absent at baseline are subsequently scored as absent, with no subsequent worsening up to Day 29.
  • Part A - Serious adverse events (SAEs) and AEs of Special Interest (AESIs) [ Time Frame: up to day 91 (EOS) ]
    In order to evaluate the safety and tolerability of ensovibep, the proportion of patients up to end of study with: (a) SAEs, including death from any cause and (b) AESIs, including infusion-related reactions (IRRs) CTCAE grade 2 or higher, will be assessed.
  • Part A - Vital Signs: Heart Rate (bpm) [ Time Frame: up to day 91 (EOS) ]
  • Part A - Vital Signs: Blood Pressure Systolic and Diastolic (mmHg) [ Time Frame: up to day 91 (EOS) ]
  • Part A - Vital Signs: Body Temperature (°C) [ Time Frame: up to day 91 (EOS) ]
  • Part A - Vital Signs: Respiratory Rate (breaths per minute) [ Time Frame: up to day 91 (EOS) ]
  • Part A - Vital Signs: Oxygen Saturation (SpO2) [ Time Frame: up to day 91 (EOS) ]
  • Part A - Number of Participants with Laboratory Abnormalities [ Time Frame: up to day 91 (EOS) ]
  • Part A - Free and total ensovibep concentration in serum (mass per volume units) [ Time Frame: up to day 91 (EOS) ]
  • Part A - Observed maximum concentration (Cmax) [ Time Frame: up to day 91 (EOS) ]
    The maximum observed concentration (Cmax) is estimated based on the serum concentrations.
  • Part A - Time to Cmax (Tmax) [ Time Frame: up to day 91 (EOS) ]
  • Part A - The area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast) [ Time Frame: up to day 91 (EOS) ]
  • Part A - The area under the concentration-time curve from time zero extrapolated to infinity time (AUCinf) [ Time Frame: up to day 91 (EOS) ]
  • Part A - Terminal Elimination Half-Life (T½) [ Time Frame: up to day 91 (EOS) ]
  • Part A - Terminal Elimination rate constant (λz) [ Time Frame: up to day 91 (EOS) ]
  • Part A - The apparent volume of distribution during terminal phase associated with λz (Vz) [ Time Frame: up to day 91 (EOS) ]
  • Part A - Apparent total body clearance of the drug from plasma (CL) [ Time Frame: up to day 91 (EOS) ]
  • Part B - SARS-CoV-2 viral load [ Time Frame: 8 days (days 1, 3, 5 and 8) ]
    Time-weighted change from baseline (measured at Day 3, Day 5, and Day 8) in SARS-CoV-2 viral load in nasopharyngeal swabs through Day 8
  • Part B - Time to sustained clinical recovery [ Time Frame: up to day 29 ]
    Time to sustained clinical recovery, defined as (a) all symptoms from the modified FDA COVID-19 symptom list scored as moderate or severe at baseline are subsequently scored as mild or absent, AND (b) all symptoms from the modified FDA COVID-19 symptom list scored as mild or absent at baseline are subsequently scored as absent, with no subsequent worsening up to Day 29.
  • Part B - Proportion of patients with treatment-emergent ADAs (TE-ADA) [ Time Frame: up to day 91 (EOS) ]
    To evaluate the immunogenicity of ensovibep during the study and its clinical relevance (pharmacokinetic, efficacy and safety), proportion of patients exhibiting TE-ADA over time will be determined.
  • Part B - SAEs and AESIs [ Time Frame: up to day 91 (EOS) ]
    In order to evaluate the safety and tolerability of ensovibep, the proportion of patients up to end of study with: (a) SAEs, including death from any cause and (b) AESIs, including IRRs CTCAE grade 2 or higher, will be assessed.
  • Part B - Vital Signs: Heart Rate (bpm) [ Time Frame: up to day 91 (EOS) ]
  • Part B - Vital Signs: Blood Pressure Systolic and Diastolic (mmHg) [ Time Frame: up to day 91 (EOS) ]
  • Part B - Vital Signs: Body Temperature (°C) [ Time Frame: up to day 91 (EOS) ]
  • Part B - Vital Signs: Respiratory Rate (breaths per minute) [ Time Frame: up to day 91 (EOS) ]
  • Part B - Vital Signs: Oxygen Saturation (SpO2) [ Time Frame: up to day 91 (EOS) ]
  • Part B - Number of Participants with Laboratory Abnormalities [ Time Frame: up to day 91 (EOS) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Dose Finding, Efficacy and Safety Study of Ensovibep (MP0420) in Ambulatory Adult Patients With Symptomatic COVID-19
Official Title  ICMJE A Randomized, Double-blind, Placebo-controlled, Multicenter Study of Ensovibep (MP0420) in Ambulatory Adult Patients With Symptomatic COVID-19 - The "EMPATHY" Trial
Brief Summary The purpose of this study is to establish the antiviral efficacy of ensovibep against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in humans, identify the optimal dose, and demonstrate its clinical value for treating COVID-19 in adult ambulatory patients.
Detailed Description

Primary objectives:

Part A: The primary objective of this Part is to demonstrate superiority of ensovibep, compared to placebo, in reducing SARS-CoV-2 viral load through Day 8.

Part B: The primary objective of this Part is to demonstrate superiority of ensovibep, compared to placebo, in reducing the occurrence of hospitalizations (≥ 24 hours of acute care) and/or emergency room visits related to COVID-19 or death from any cause up to Day 29.

Secondary objectives:

Part A: The secondary objectives of this Part are:

  • To assess the effect of ensovibep, compared to placebo, in reducing the occurrence of hospitalizations (≥ 24 hours of acute care) and/or emergency room visits related to COVID-19 or death from any cause up to Day 29
  • To assess the effect of ensovibep, compared to placebo, in reducing COVID-19 symptoms through Day 29
  • To evaluate safety and tolerability of ensovibep
  • To characterize the pharmacokinetics (PK) of ensovibep

Part B: The secondary objectives of this Part are:

  • To assess the effect of ensovibep, compared to placebo, in reducing SARS-CoV-2 viral load through Day 8
  • To assess the effect of ensovibep, compared to placebo, in reducing COVID-19 symptoms up to Day 29
  • To evaluate the immunogenicity of ensovibep during the study and its clinical relevance (PK, efficacy and safety)
  • To evaluate safety and tolerability of ensovibep

Although Amendment 2 was created, modifications for this amendment are not reflected as it was never approved or implemented in the US. The study was conducted under Global Protocol Amendment 1, the last active version of the protocol.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
  • Parallel: participants are assigned to one of two or more groups in parallel for the duration of the study.
  • 4 Arms under Phase 2 and 2 Arms under Phase 3
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
  • Double Blind: two or more parties are unaware of the intervention assignment
  • Masked roles are: Subject, Caregiver, Investigator or Outcomes Assessor.
Primary Purpose: Treatment
Condition  ICMJE COVID-19
Intervention  ICMJE
  • Drug: ensovibep
    IV on day 1 only.
    Other Name: MP0420
  • Drug: Placebo
    IV on day 1 only.
Study Arms  ICMJE
  • Experimental: Phase 2 / Part A, ensovibep active treatment arm 1
    Phase 2 / Part A: ensovibep active treatment arm 1
    Intervention: Drug: ensovibep
  • Experimental: Phase 2 / Part A, ensovibep active treatment arm 2
    Phase 2 / Part A: ensovibep active treatment arm 2
    Intervention: Drug: ensovibep
  • Experimental: Phase 2 / Part A, ensovibep active treatment arm 3
    Phase 2 / Part A: ensovibep active treatment arm 3
    Intervention: Drug: ensovibep
  • Placebo Comparator: Phase 2 / Part A, Placebo
    Phase 2 / Part A: Placebo
    Intervention: Drug: Placebo
  • Experimental: Phase 3/ Part B, ensovibep active treatment arm 4
    Phase 3/ Part B: ensovibep active treatment. Part B was not initiated.
    Intervention: Drug: ensovibep
  • Placebo Comparator: Phase 3/ Part B, Placebo arm
    Phase 3/ Part B: Placebo. Part B was not initiated.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: July 1, 2022)
407
Original Estimated Enrollment  ICMJE
 (submitted: March 30, 2021)
2100
Actual Study Completion Date  ICMJE January 27, 2022
Actual Primary Completion Date November 18, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Part A Inclusion Criteria:

  1. Men and women ≥ 18 years of age on the day of inclusion (no upper limit).
  2. Presence of two or more of the following COVID-19 symptoms with an onset within 7 days of dosing: Feeling hot or feverish, cough, sore throat, low energy, or tiredness, headache, muscle or body aches, chills or shivering, and shortness of breath.
  3. Positive test for SARS-CoV-2 in upper respiratory swab on the day of dosing (rapid antigen test).
  4. Understand and agree to comply with the planned study procedures.
  5. The patient or legally authorized representative give signed informed consent.

Part A Exclusion Criteria:

  1. Requiring hospitalization at time of screening, or at time of study drug administration.
  2. Oxygen saturation (SpO2) ≤ 93% on room air at sea level or ratio of arterial oxygen partial pressure (PaO2 in mmHg) to fractional inspired oxygen (FiO2) < 300, respiratory rate ≥ 30 per minute, and heart rate ≥ 125 per minute. In India, patients with a respiratory rate ≥ 24 per minute or with an oxygen saturation ≤ 93% on room air (SpO2) are not eligible.
  3. Known allergies to any of the components used in the formulation of the ensovibep or placebo.
  4. Suspected or proven serious, active bacterial, fungal, viral, or other infection (besides SARS-CoV-2) that in the opinion of the investigator could constitute a risk when taking intervention.
  5. Any serious concomitant systemic disease, condition, or disorder that, in the opinion of the investigator, should preclude participation in this study.
  6. Any co-morbidity requiring surgery within 7 days of dosing, or that is considered life-threatening within 29 days of dosing.
  7. Prior or concurrent use of any medication for treatment of COVID-19, including antiviral agents, convalescent serum, or anti-viral antibodies. Purely symptomatic therapies (e.g., over-the-counter [OTC] cough medications, acetaminophen, and nonsteroidal anti-inflammatory drugs [NSAIDs]) are permitted. Prior vaccination for COVID-19 is permitted.
  8. Are concurrently enrolled or were enrolled within the last 30 days or within 5 half-lives (whichever is longer) in any other type of medical research judged not to be scientifically or medically compatible with this study.
  9. Are pregnant or breast feeding.
  10. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception at the time of dosing and for 11 weeks after dosing of study drug. Highly effective contraception methods include:

    1. Total abstinence (when this is in line with the preferred and usual lifestyle of the patient). Periodic abstinence (i.e., calendar, ovulation, symptothermal, and postovulation methods) and withdrawal are not acceptable methods of contraception.
    2. Female sterilization (have had bilateral surgical oophorectomy [with or without hysterectomy], total hysterectomy, or bilateral tubal ligation at least 6 weeks before taking study treatment). In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment.
    3. Male sterilization (at least 6 months prior to screening). The vasectomized male partner should be the sole partner for that patient.
    4. Use of oral, injected, or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS) or other forms of hormonal contraception that have comparable efficacy (failure rate < 1%), for example hormone vaginal ring or transdermal hormone contraception. In case of use of oral contraception, women should have been stable on the same pill for a minimum of 3 months before taking study treatment. If local regulations deviate from the contraception methods listed above to prevent pregnancy, local regulations apply and will be described in the informed consent form (ICF).
  11. Patients in the USA who are at high risk of progression to severe COVID-19 illness or hospitalization must not be enrolled in Part A of this study as a placebo-controlled study may not be appropriate in this patient population due to the availability of anti-viral mAbs under EUA in the USA.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Hungary,   India,   Netherlands,   South Africa,   United States
Removed Location Countries Poland
 
Administrative Information
NCT Number  ICMJE NCT04828161
Other Study ID Numbers  ICMJE MP0420-CP302
2021-000890-10 ( EudraCT Number )
CSKO136A12201J ( Other Identifier: Novartis Pharmaceuticals )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on https://www.clinicalstudydatarequest.com/.

URL: https://www.clinicalstudydatarequest.com/
Current Responsible Party Novartis ( Novartis Pharmaceuticals )
Original Responsible Party Molecular Partners AG
Current Study Sponsor  ICMJE Novartis Pharmaceuticals
Original Study Sponsor  ICMJE Molecular Partners AG
Collaborators  ICMJE Molecular Partners AG
Investigators  ICMJE Not Provided
PRS Account Novartis
Verification Date December 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP