Efficacy and Safety of Zasocitinib in Pediatric Participants with Moderate-to-Severe Plaque Psoriasis: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Trial

Trial ID: 2025-522567-15-00
Protocol: TAK-279-PsO-3006
Sponsor: Takeda Development Center Americas Inc.

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Diseases & Conditions

Psoriasis

Objectives

The primary objective of this study is to evaluate the efficacy of zasocitinib administered orally once daily for 16 weeks in pediatric participants aged 4 to less than 18 years with moderate-to-severe plaque psoriasis. Part A focuses on comparing the therapeutic effect of the selected dose against a placebo in two distinct cohorts: adolescents aged 12 to less than 18 years and children aged 4 to less than 12 years. Part B aims to assess the pharmacokinetics of zasocitinib following multiple daily oral doses in the pediatric population. Secondary objectives include:

Further assessment of efficacy compared to placebo in Cohort 1 and Cohort 2 during Part A.
Evaluation of efficacy over the duration of the open-label period for both adolescents and children in Parts A and B.
Assessment of the pharmacokinetics of zasocitinib in participants within Cohort 1 and Cohort 2 during Part A.
Evaluation of the palatability of the medication in pediatric participants during Part B.

Participants

This clinical trial involves 56 participants diagnosed with plaque psoriasis. The study population consists of pediatric and adolescent patients, including both males and females, who present with moderate-to-severe disease. The current enrollment is restricted to adolescent participants aged 12 to <18 years in Cohort 1, with future stages planned for children aged 4 to <12 years. Eligible participants must have had a diagnosis of chronic plaque psoriasis for at least 6 months and have maintained stable disease morphology for the same duration. Clinical requirements for inclusion include a PASI score ≥12, an sPGA score ≥3, and skin involvement covering ≥10% of the total BSA. Participants must be candidates for phototherapy or systemic therapy. Specific requirements for the adolescent cohort include a weight of ≥40 kg and the ability to swallow oral medication. Additionally, women of childbearing potential must agree to use highly effective contraception during the trial and for 10 days following the final dose.

Plans and Procedures

This Phase 3, randomized, multicenter, double-blind, placebo-controlled trial is designed to evaluate the efficacy, safety, tolerability, and pharmacokinetics of zasocitinib in pediatric participants with plaque psoriasis. The study is divided into two distinct parts. Part A involves a randomized comparison between zasocitinib, administered as an oral film-coated tablet once daily, and a matching placebo for 16 weeks in participants aged 12 to less than 18 years. Part B is an open-label pharmacokinetics trial for children aged 4 to less than 12 years to evaluate the pharmacokinetics of the drug following multiple daily doses. The research methodology includes a screening visit to confirm diagnosis and eligibility, followed by treatment periods and scheduled follow-up visits to monitor clinical responses and safety. Primary efficacy endpoints for Part A include the static Physician Global Assessment (sPGA) and the Psoriasis Area and Severity Index (PASI) at week 16. For Part B, primary endpoints focus on pharmacokinetic parameters such as Cmax, Tmax, and AUC on day 7. Total study duration is estimated to conclude by January 2033.

Treatment

Zasocitinib is an investigational medicinal product administered as a film-coated tablet. The substance is intended for oral administration on a once daily basis to participants with plaque psoriasis.

A matching placebo is utilized as a comparator treatment in the study. This non-experimental substance is administered via the same route and schedule as the test medication to maintain the double-blind design of the trial.

Efficacy

The efficacy of zasocitinib in participants with plaque psoriasis is evaluated through various clinical endpoints. In Part A, the coprimary endpoints assessed at week 16 include the proportion of participants achieving an sPGA 0/1 response, defined as a score of clear (0) or almost clear (1) with a minimum 2-point decrease from baseline, and the PASI-75 response, representing a 75% improvement from baseline in the PASI score. Secondary efficacy assessments at week 16 include the PASI-90 response, PASI-100 response, enhanced sPGA response (achieving a score of clear), and the ssPGA response for participants with a baseline score of 3 or greater. Additional evaluations involve changes in the BSA affected by psoriasis and responses in the DLQI and CDLQI scores. For adolescent participants in Cohort 1, the Itch NRS response and change from baseline are also measured at week 16.

During the open-label period, efficacy parameters such as PASI responses, sPGA, ssPGA, BSA, DLQI, CDLQI, and Itch NRS for Cohort 1 are monitored at each scheduled visit. In Part B, the primary focus is on pharmacokinetics, with efficacy-related PK parameters, including Cmax, Tmax, and AUC0-Last, measured on day 7. Secondary assessments in Part B include acceptability and palatability scores.

Inclusion and Exclusion Criteria

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Inclusion Criteria

In the opinion of the investigator, the participant (as age appropriate) and/or LAR or adult caregiver is capable of understanding and complying with protocol requirements.
Before the initiation of any trial assessments or procedures: • The participant, participant’s LAR, or adult caregiver signs and dates a written ICF; and • Pediatric assent is obtained (where appropriate); and • Any required privacy authorization is also obtained, as required per local regulations.
Participant has a diagnosis of chronic plaque psoriasis for ≥6 months prior to the screening visit.
Participant has stable plaque psoriasis defined as no significant flare or change in morphology (as assessed by the investigator) in psoriasis for ≥6 months before screening.
Participant has moderate-to-severe plaque psoriasis as defined by a PASI score ≥12 and an sPGA score ≥3 at screening and Day 1.
Participant has plaque psoriasis covering ≥10% of total BSA at screening and Day 1.
Participant must be a candidate for phototherapy or systemic therapy.
Inclusion Criteria for Part A Cohort 1: The participant is male or female and aged 12 to <18 years, at the time of screening and informed consent. – Note: Under this protocol amendment, ONLY eligible participants who are ≥12 years of age (that is, Part A Cohort 1) at screening will be enrolled. Upon availability of the juvenile toxicity data and phase 3 safety data in adults, a future protocol amendment is planned to initiate the enrollment of participants who are <12 years of age in Part B (open-label PK trial, aged 4 to <12 years) followed by the enrollment of Part A Cohort 2 (aged 4 to <12 years). Part B participants will be separate from Part A Cohort 2 participants. Part A Cohort 2 will be initiated after adequate data becomes available from Part B to determine the dose.
In the EU/EEA, for participants currently smoking or using chewing tobacco, the investigator must document a favorable benefit-risk assessment to justify the participants’ inclusion in the trial.
A WOCBP (as defined in Section 13.1.1.1) who is sexually active with a male partner agrees to use a highly effective method of contraception (as listed in Section 13.1.2.1.1) from signing of participant/parental informed consent and pediatric assent (if applicable) throughout the duration of the trial and for 10 days after the last dose of trial intervention. The use of effective contraception is not required for participants assigned male sex at birth during the duration of the trial. Pregnancy reporting responsibilities are defined in Section 8.5.1.1. • In the EU/EEA, for participants who elect to use hormonal contraception as a form of highly effective contraception, the investigator must document a favorable benefit-risk assessment at screening and every 3 months during the trial, to justify the participant's inclusion in the trial. Note: Oral hormonal contraception may be susceptible to interaction with zasocitinib, which may reduce the efficacy of the contraceptive method. Therefore, if the participant chooses oral hormonal contraception as the primary highly effective method of contraception, a second highly effective or an acceptable method of contraception should also be used during the treatment period and for at least 10 days after the last dose of trial intervention, if the participant is sexually active with a partner with whom the participant could become pregnant. A barrier method is recommended, preferably a male condom.
For participants in the EU/EEA, the investigator must have no reason to believe that the participant would be placed at risk by participating in the trial with regard to the European Commission Decision as of 10 March 2023 on measures to minimize risk of serious side effects with JAKi (EMA/142279/2023 guideline on JAKi): new measures to reduce risks of major cardiovascular events, malignancy, venous thromboembolism, serious infections and increased mortality as of 26 April 2023 (Drug Safety Update volume 16, issue 9).
Inclusion Criteria for Part A Cohort 1: The participant must weigh ≥40 kg at the time of screening in order to be enrolled in the trial.
Inclusion Criteria for Part A Cohort 1: The participant, participant’s LAR, or adult caregiver should be confident that the participant will be able to swallow.

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Exclusion Criteria

Participant has evidence of nonplaque psoriasis (erythrodermic, pustular, predominantly guttate psoriasis, predominantly inverse, or drug-induced psoriasis). If a participant meets criteria for inclusion based on typical plaque psoriasis presentation, a limited amount of inverse psoriasis is not exclusionary.
Participant requires systemic treatment, other than NSAIDs, during the trial period for an immune-related disease (for example, inflammatory bowel disease).
Participant has a history of excessive sun exposure, has used tanning booths within 4 weeks prior to Day 1, or is not willing to minimize natural and artificial sunlight exposure during the trial period. Use of sunscreen products and protective apparel is recommended when sun exposure cannot be avoided.
Participant has concomitant comorbid skin condition that, in the opinion of the investigator, would interfere with the trial assessments.
TB: a) Participant has history of active TB infection, regardless of treatment status. b) Participant has signs or symptoms of active TB (including, but not limited to, chronic fever, chronic productive cough, night sweats, or weight loss) as judged by the investigator. c) Participant has evidence of LTBI as evidenced by a positive QFT result OR 2 indeterminate QFT results and participant does not have documentation of appropriate LTBI prophylaxis or is not able or not willing to initiate appropriate LTBI prophylaxis. Participant remains eligible if there are no signs/symptoms of active TB AND participant can provide documentation of no history of active TB AND either: (1) participant can provide documentation of prior and complete treatment for LTBI (appropriate in duration and type per current local country guidelines) OR (2) participant has initiated prophylaxis (appropriate in duration and type per current local guidelines) a minimum of 2 weeks prior to Day 1. In the EU/EEA, participants with evidence of LTBI, regardless of prophylaxis treatment status, must receive approval to participate in the trial from an infectious disease or other TB specialist (for example, pulmonologist). – Note: TB prophylaxis regimens should be administered according to local guidelines; however, because of potential interactions with zasocitinib, rifampin should not be used. Additional excluded medications are provided in Table 6.b and Table 13.d, and the investigator should consult with the medical monitor to discuss any LTBI treatment medication not listed if treatment will occur during the trial. – Note: TB testing should be conducted using QFT submitted to the central laboratory. Additional tests may be performed as required per local guidelines. – Note: For participants who have documentation of LTBI and who have completed a course of prophylaxis (appropriate in duration and type per current local country guidelines and documented in the medical record), QFT does not need to be performed. d) Participant has had any imaging during or 6 months prior to screening, including chest X-ray, chest CT, MRI of the chest, or other chest imaging suggesting evidence of current active or a history of active TB. Chest X-ray is required for all participants regardless of QFT results as allowed per country-specific guidelines and regulations unless the participant has had normal chest imaging within 6 months prior to screening.
Herpes infections: a) Participant has active herpes virus infection, including herpes zoster or herpes simplex 1 and 2 (demonstrated on physical examination and/or medical history) at screening or Day 1. b) Participant has history of serious herpetic infection that includes any episode of disseminated disease; multidermatomal herpes zoster, herpes encephalitis, or ophthalmic herpes; or a history of recurrent herpes zoster (defined as 2 episodes within 2 years).
Nonherpetic viral diseases: a) HCV: • Participant has presence of HCV Ab and a positive confirmatory test result for HCV RNA (nucleic acid test or PCR). – In the EU/EEA, if the participant has positive total HCV Ab at screening but is confirmed to have no detectable HCV RNA by PCR testing, HCV RNA PCR testing will be performed per the SoA (Section 1.3). b) HBV: • Participant has presence of positive or indeterminate HBsAg; or • Participant has presence of HBV DNA (regardless of serology); or • Participant has presence of positive HBcAb without concurrent positive HBsAb (HBcAb+ and HBsAb-). – In the EU/EEA: o If the participant has positive total HBcAb at screening (HBcAb+; note that HBcAb+ without concurrent HBsAb+ is exclusionary) and is confirmed to have no detectable HBV DNA by PCR testing, the HBV DNA PCR testing will be performed per the SoA (Section 1.3); or o If a participant has isolated positive HBsAb at screening but is without documentation of prior vaccination as proven by medical records and is confirmed to have no detectable HBV DNA by PCR testing, the participant will repeat HBV DNA PCR testing per the SoA (Section 1.3). c) HIV: • Participant has positive results for HIV by serology, regardless of viral load.
Other infectious diseases: a) Participant has a history of active infection or febrile illness within 7 days prior to Day 1, as assessed by the investigator. b) Participant has history of symptoms suggestive of systemic or invasive infection within 30 days prior to Day 1, as assessed by the investigator. c) Participant has history of bacterial, viral, or fungal infection that required hospitalization or treatment with intravenous antimicrobial therapy within 8 weeks prior to Day 1 or oral antimicrobial therapy within 30 days prior to Day 1. d) Participant has a history of chronic or recurrent bacterial disease, including but not limited to chronic pyelonephritis or cystitis, chronic bronchitis/pneumonitis, osteomyelitis, or chronic skin ulcerations/infections or fungal infections (except superficial onychomycosis). e) Participant has a history of an infected joint prosthesis, unless that prosthesis has been removed or replaced at least 60 days prior to Day 1. f) Participant has a history of opportunistic infections (for example, Pneumocystis jirovecii pneumonia, histoplasmosis, coccidiomycosis). g) Participant had a confirmed bacterial infection requiring antibiotic treatment within 60 days prior to Day 1, as assessed by the investigator, for which he or she did not receive treatment.
Participant has any clinically significant medical condition, evidence of an unstable clinical condition (for example, cardiovascular, renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, or immunologic), or vital signs/physical examination/laboratory/ECG abnormality that would, in the opinion of the investigator, put the participant at undue risk or interfere with interpretation of trial results. These include but are not limited to: a) Participant has a history of known or suspected condition/illness that is consistent with compromised immunity, including but not limited to any identified congenital or acquired immunodeficiency or history of splenectomy. b) Participant had a major surgery within 60 days prior to Day 1 or has a major surgery planned during the trial. c) Participant has unstable, poorly controlled, or severe hypertension (defined as BP exceeding the 95th percentile for age, sex, and height) at screening, confirmed by 2 repeat assessments. d) Participant has a history of Class III or IV congestive heart failure as defined by NYHA criteria. e) Participant has a history of malignancy or lymphoproliferative disease, with the exception of successfully treated nonmetastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix; in the EU/EEA, investigators must specifically document a favorable benefit-risk assessment. f) For participants with asthma, chronic obstructive pulmonary disease, or other pulmonary illnesses, participant has been hospitalized in the past 3 months, has ever required intubation for treatment, currently requires oral corticosteroids, or has required more than 1 course of oral corticosteroids within 6 months prior to Day 1. g) Participant has any of the following cardiovascular disease history: • A new diagnosis of atrial fibrillation or an episode of atrial fibrillation with rapid ventricular response or other dysrhythmia, nonacute cardiac hospitalization (for example, pacemaker implantation), pulmonary embolism, or deep venous thrombosis within the past 6 months prior to screening. • Any history of cerebrovascular event, myocardial infarction, coronary stenting, or aorto-coronary bypass surgery. If, however, the investigator determines there are no suitable treatment alternatives available for the participant and it has been at least 6 months since the occurrence of any such event, the participant may enroll; in the EU/EEA, investigators must specifically document a favorable benefit-risk assessment. h) Participant has ECG abnormalities that are considered clinically significant and would pose an unacceptable risk to the participant if he or she participated in the trial, in the opinion of the investigator. i) Participant has significant/uncontrolled psychiatric illness, in the opinion of the investigator. j) Participant has a history of clinically significant drug or alcohol abuse within 12 months prior to Day 1.
For the below prohibited psoriasis treatment, the washout period prior to Day 1 is within the time frame indicated or 5 half-lives, whichever is longer, regardless of whether they are prescribed for psoriasis or another condition: Note: If the participant is currently receiving an approved therapy for psoriasis that is not permitted in the trial, but the approved therapy is well-tolerated and effective for moderate-to-severe psoriasis in the opinion of the participant and the investigator, the participant should not discontinue this therapy solely to enter the clinical trial. 10. Participant has received any of the following biologics or biosimilar versions within the time frame indicated: a) Antibodies to IL-12/-23, IL-17, or IL-23 (for example, ustekinumab, secukinumab, bimekizumab, risankizumab, tildrakizumab, ixekizumab, guselkumab, brodalumab, or biosimilar versions) within 6 months prior to Day 1. b) TNF inhibitor(s) (for example, etanercept, adalimumab, infliximab, certolizumab, or biosimilar versions) within 2 months prior to Day 1. c) Agents that modulate integrin pathways to impact lymphocyte trafficking (for example, natalizumab) or agents that modulate B cells or T cells (for example, alemtuzumab, abatacept, or visilizumab) within 3 months prior to Day 1. d) Rituximab or other immune cell–depleting therapy within 6 months prior to Day 1.
For the below prohibited psoriasis treatment, the washout period prior to Day 1 is within the time frame indicated or 5 half-lives, whichever is longer, regardless of whether they are prescribed for psoriasis or another condition. 11. Participant has used medicated shampoo and/or body wash, including formulations containing but not limited to salicylic acid, corticosteroids, coal tar, vitamin D3 analogues, or other compounds used for the management of psoriasis, within 2 weeks prior to Day 1.
For the below prohibited psoriasis treatment, the washout period prior to Day 1 is within the time frame indicated or 5 half-lives, whichever is longer, regardless of whether they are prescribed for psoriasis or another condition. 12. Participant has used any topical medication that could affect psoriasis presentation (including but not limited to corticosteroids, salicylic acid, urea, alpha- or beta-hydroxy acids, anthralin, retinoids, vitamin D analogues [such as calcipotriol], methoxsalen, trimethylpsoralen, calcineurin inhibitors [for example, tacrolimus or pimecrolimus], tapinarof, roflumilast, JAK inhibitors, or tar) within 2 weeks prior to Day 1. • Note: Low-potency topical corticosteroids (WHO Class VI and VII or equivalent) are permitted for use on the palms, soles, face, and/or intertriginous areas, but should not be used within 24 hours before any trial visit. Low-potency topical corticosteroids may be used to treat acute nonpsoriatic conditions (for example, contact dermatitis) on all body regions for no more than 2 weeks but should not be used within 24 hours before any trial visit. Low-potency topical corticosteroids co-formulated with other topical medication(s) that may affect the presentation of psoriasis are not permitted. Bland emollients (defined as emollients containing only ingredients that are pharmacologically inactive) are allowed on all body regions but should not be used within 24 hours before any trial visit. • Note: Intranasal corticosteroids, inhaled corticosteroids, and ophthalmic and otic drops containing corticosteroids are permitted.
For the below prohibited psoriasis treatment, the washout period prior to Day 1 is within the time frame indicated or 5 half-lives, whichever is longer, regardless of whether they are prescribed for psoriasis or another condition. 13. Participant has used any systemic nonbiologic treatment that could affect psoriasis presentation (including oral, intravenous, intramuscular, intra-articular, intrathecal, or intralesional corticosteroids; oral retinoids; immunosuppressive/immunomodulating medication; apremilast; methotrexate; azathioprine; 6-thioguanidine; mercaptopurine; mycophenolate mofetil; hydroxyurea; cyclosporine; 1,25-dihydroxyvitamin D3 analogues; psoralens; sulfasalazine; fumaric acid derivatives; JAK inhibitors) within 4 weeks prior to Day 1, or 5 half-lives, whichever is longer.
For the below prohibited psoriasis treatment, the washout period prior to Day 1 is within the time frame indicated or 5 half-lives, whichever is longer, regardless of whether they are prescribed for psoriasis or another condition. 14. Participant has used leflunomide within 6 months prior to Day 1.
For the below prohibited psoriasis treatment, the washout period prior to Day 1 is within the time frame indicated or 5 half-lives, whichever is longer, regardless of whether they are prescribed for psoriasis or another condition. 15. Participant has received phototherapy (including UVB, PUVA, tanning beds, therapeutic sunbathing) or excimer laser within 4 weeks prior to Day 1.
For the below prohibited psoriasis treatment, the washout period prior to Day 1 is within the time frame indicated or 5 half-lives, whichever is longer, regardless of whether they are prescribed for psoriasis or another condition. 16. Participant has used oral or topical botanical preparations (for example, herbal supplements or traditional medicines, including traditional Chinese medicines, derived from plants, minerals, or animals) intended to treat psoriasis or other immunological diseases within 4 weeks prior to Day 1.
For the below prohibited psoriasis treatment, the washout period prior to Day 1 is within the time frame indicated or 5 half-lives, whichever is longer, regardless of whether they are prescribed for psoriasis or another condition. 17. Participant has any previous exposure to zasocitinib (also known as TAK-279 or NDI-034858) or other TYK2 inhibitors (including deucravacitinib), or participated in any trial that included a TYK2 inhibitor (for example, deucravacitinib, VTX958, GLPG3667, and so forth), unless participant has documentation of posttrial unblinding that confirms the participant did not receive a TYK2 inhibitor.
For the below prohibited concomitant medication, where applicable, the washout period prior to Day 1 is within the time frame indicated or 5 half-lives, whichever is longer. 18. Participant has received lithium, antimalarials, or intramuscular gold therapy within 4 weeks prior to Day 1.
For the below prohibited concomitant medication, where applicable, the washout period prior to Day 1 is within the time frame indicated or 5 half-lives, whichever is longer. 19. Participant is currently being treated with strong or moderate CYP3A4 inhibitors (such as itraconazole) or strong or moderate CYP3A4 inducers (such as rifampin, carbamazepine, or phenytoin), or has received strong or moderate CYP3A4 inhibitors or strong or moderate CYP3A4 inducers within 4 weeks or 5 half-lives of the inducer or inhibitor, whichever is longer, prior to Day 1, or is anticipated to require treatment with strong or moderate CYP3A4 inducers or inhibitors during the trial period (see Table 13.d). • Note: This includes consumption of food or beverages containing grapefruit and/or Seville oranges within 1 week of Day 1. Participants must be counseled to avoid food or beverages containing grapefruit and/or Seville oranges for the duration of the trial.
For the below prohibited concomitant medication, where applicable, the washout period prior to Day 1 is within the time frame indicated or 5 half-lives, whichever is longer. 20. Participant has received any live-attenuated vaccine within 60 days prior to Day 1 or plans to receive a live-attenuated vaccine during the trial and for up to 4 weeks after the last trial intervention administration. • Note: Non–live-attenuated vaccines for COVID-19 and/or influenza are permitted during the trial.
For the below prohibited concomitant medication, where applicable, the washout period prior to Day 1 is within the time frame indicated or 5 half-lives, whichever is longer. 21. Participant received an investigational Ab or biologic therapy within 6 months prior to Day 1.
For the below prohibited concomitant medication, where applicable, the washout period prior to Day 1 is within the time frame indicated or 5 half-lives, whichever is longer. 22. Participant received or is receiving the following: a) Participant received an investigational oral therapy within 3 months prior to Day 1; or b) Participant is currently receiving a nonbiological trial intervention or device or has received one within 4 weeks prior to Day 1; or c) Participant is currently enrolled in another clinical trial or anticipates enrollment in another clinical trial during the course of the trial.
Participant has any of the following laboratory values at the screening visit: a) AST or ALT values >3×ULN. b) Tbili (unconjugated and/or conjugated) >1.5×ULN. c) ALP >1.5×ULN. d) Hgb <10.0 g/dL (<100.0 g/L). e) Absolute WBC count <4.0×109/L (<4000/mm3). f) ANC of <1.0×109/L (<1000/mm3). g) ALC of <1.0×109/L (<14000/mm3). h) Platelet count <100×109/L (<100,000/mm3). i) Estimated GFR <30 mL/min based on the pediatric bedside Schwartz equation (as referenced in Section 8.3.4.1). j) CPK >ULN. CPK may be repeated once; if repeat value is NCI CTCAE v5.0 Grade 1 or lower (or ≤2.5×ULN) and no higher than the initial value, participant remains eligible. Investigators should assess the participant for modulating factors, including concomitant medications or vigorous exercise, that may affect CPK levels.
Participant has any other significant laboratory abnormalities that, in the opinion of the investigator, might place the participant at unacceptable risk for participation in this trial.
Participant does not tolerate venipuncture or inability to be venipunctured.
Participant has a history of significant drug allergy (such as anaphylaxis).
Participant has a known or suspected allergy to zasocitinib or any of its components.
Participant has a positive pregnancy test result or plans to become pregnant during the trial period, or participant is pregnant or lactating/nursing.
Participants who have given greater than 500 mL of blood or plasma within 30 days of screening (during a clinical trial or at a blood bank donation) or plan to donate blood during the course of the trial.
Participant is compulsorily detained for treatment of either a psychiatric or physical (for example, infectious disease) illness, or is committed to an institution (for example, prison) by virtue of an order issued either by judicial or administrative authorities.
Participant is a trial site employee, an immediate family member (for example, spouse, parent, child, sibling) of a trial site employee, or is in a dependent relationship with a trial site employee who is involved in the conduct of this trial or may consent under duress.
Participant is not up to date on all required vaccinations according to current immunization guidelines as noted by country-specific pediatric authorities.
In Germany, the participant is incapable of giving consent or otherwise meets criteria in Sections 136 or 137 of the Verordnung zum Schutz vor der schädlichen Wirkung ionisierender Strahlung – Strahlenschutzverordnung.