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A Study to Evaluate the Efficacy, Safety, and Tolerability of NDI-034858 in Participants With Active Psoriatic Arthritis

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ClinicalTrials.gov Identifier: NCT05153148
Recruitment Status : Completed
First Posted : December 10, 2021
Last Update Posted : March 19, 2024
Sponsor:
Collaborator:
Nimbus Lakshmi, Inc.
Information provided by (Responsible Party):
Takeda

Tracking Information
First Submitted Date  ICMJE November 26, 2021
First Posted Date  ICMJE December 10, 2021
Last Update Posted Date March 19, 2024
Actual Study Start Date  ICMJE January 6, 2022
Actual Primary Completion Date June 2, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 15, 2024)
Proportion of participants achieving at least an American College of Rheumatology (ACR) 20 response [ Time Frame: At Week 12 ]
The ACR20 is a composite measure defined as both improvement of 20% in the number of tender (68) and number of swollen (66) joints, and a 20% improvement in three of the following five criteria: patient global assessment of psoriatic arthritis, physician global assessment of psoriatic arthritis, patient pain scale, disability history questionnaire (ie, HAQ-DI) and an acute phase reactant (ie, erythrocyte sedimentation rate [ESR] or hsCRP). For this primary endpoint, hsCRP will be used.
Original Primary Outcome Measures  ICMJE
 (submitted: December 9, 2021)
Proportion of subjects achieving at least an American College of Rheumatology (ACR) 20 response [ Time Frame: Day 1 to Week 16 ]
The ACR20 is a composite measure defined as both improvement of 20% in the number of tender (68) and number of swollen (66) joints, and a 20% improvement in three of the following five criteria: patient global assessment of psoriatic arthritis, physician global assessment of psoriatic arthritis, patient pain scale, disability history questionnaire (ie, HAQ-DI) and an acute phase reactant (ie, erythrocyte sedimentation rate [ESR] or hsCRP). For this primary endpoint, hsCRP will be used.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 15, 2024)
  • Proportion of participants achieving at least an ACR-50 or ACR-70 response [ Time Frame: At Week 12 ]
    The ACR-50 and ACR-70 are a composite measure defined as both improvement of 50% or 70%, respectively, in the number of tender (68) and number of swollen (66) joints, and a 50% or 70%, respectively, improvement in three of the following five criteria: patient global assessment of psoriatic arthritis, physician global assessment of psoriatic arthritis, patient pain scale, disability history questionnaire (ie, HAQ-DI) and an acute phase reactant (ie, ESR or CRP).
  • Change from baseline in tender joint count (TJC) [ Time Frame: Baseline (Day 1), Week 12 ]
    The TJC 68 are a total score of points assigned for presence of tenderness in the following: Temporomandibular, sternoclavicular, acromioclavicular, shoulder, elbow, wrist, hip, knee, ankle, tarsus, typically assigned 2 points each; Metacarpophalangeal, finger proximal interphalangeal, metatarsophalangeal, toe proximal interphalangeal, typically assigned 10 points each; Distal interphalangeal, typically assigned 8 points.
  • Change from baseline in swollen joint count (SJC) [ Time Frame: Baseline (Day 1), Week 12 ]
    The SJC 66 (SJC minus hip joints, which cannot be assessed for swelling) are a total score of points assigned for presence of swelling in the following: Temporomandibular, sternoclavicular, acromioclavicular, shoulder, elbow, wrist, knee, ankle, tarsus, typically assigned 2 points each; Metacarpophalangeal, finger proximal interphalangeal, metatarsophalangeal, toe proximal interphalangeal, typically assigned 10 points each; Distal interphalangeal, typically assigned 8 points.
  • Change from baseline in Patient Global Assessment of Psoriatic Arthritis [ Time Frame: Baseline (Day 1), Week 12 ]
    Participants will rate their assessment of their PsA using a VAS where 0 is 'very good, no symptoms' and 100 is 'very poor, severe symptoms'.
  • Change from baseline in Patient Global Assessment of Psoriatic Arthritis pain [ Time Frame: Baseline (Day 1), Week 12 ]
    Participants will rate their assessment of their PsA using a VAS where 0 is 'no pain' and 100 is 'most severe pain'.
  • Change from baseline in Physician Global Assessment of Psoriatic Arthritis [ Time Frame: Baseline (Day 1), Week 12 ]
    The participants' overall disease status will be assessed, taking into account signs, symptoms, and function, of all components of joint and skin which is affected at the time of the visit and will rate this overall status using a VAS scale where 0 is 'very good, asymptomatic, and no limitation of normal activities' and 100 is 'very poor, very severe symptoms which are intolerable, and inability to carry out all normal activities'.
  • Change from baseline in Health Activities Questionnaire - Disability Index (HAQ-DI) score [ Time Frame: Baseline (Day 1), Week 12 ]
    The HAQ-DI is comprised of eight domains: dressing, arising, eating, walking, hygiene, reach, grip, and activities. There are two or three questions per section. Scoring within each section is from 0 (without any difficulty) to 3 (unable to do). For each section the score given to that section is the worst score within the section (ie, if one question is scored 1 and another 2, then the score for the section is 2).
  • Change from baseline in dactylitis count [ Time Frame: Baseline (Day 1), Week 12 ]
    The dactylitis count consists of totaling the number of single digits in the hands and feet with tenderness.
  • Change from baseline in Leed's Enthesitis Index (LEI) [ Time Frame: Baseline (Day 1), Week 12 ]
    The LEI is comprised of review of six bilateral sites: Achilles tendon insertions, medial femoral condyles, and lateral epicondyles of the humerus. Tenderness at each site is quantified on a dichotomous basis: 0 means nontender and 1 means tender.
  • Proportion of Participants With Minimal Disease Activity (MDA) [ Time Frame: At Week 12 ]
    The MDA criteria assess 7 domains: number of tender joints (0-68), number of swollen joints (0-66), visual analogue scale (VAS) for pain (0-100 mm, 100 mm=most pain), VAS for patient's global assessment (0-100 mm, 100 mm=worst score), tender entheseal point and Psoriasis Area and Severity Index(PASI)/body surface area(BSA). Functional disability is assessed by the Health Assessment Questionnaire (HAQ) (0-3=most functional disability). The MDA criteria have the following cutoffs: tender joint count less than and equal to (<=) 1, swollen joint count <=1, enthesitis count <=1, PASI <=1 (or BSA <=3%), function score <=0.5 (measured by the HAQ), patient's global assessment ,<=20 and patient-reported pain <=15 on a 100-mm VAS. If 5 of the 7 cutoffs for these domains are met, then the participant is classified as having MDA.
  • Change From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) [ Time Frame: Baseline (Day 1), Week 12 ]
    The DAPSA score is a composite score calculated using scores from TJC of 68 joints and SJC of 66 joints, patient's global assessment of PsA and patient's global assessment of PsA pain scores on a VAS, and the high sensitivity C-reactive protein (hsCRP) level. The total scores ranges from 0 to 50. A DAPSA score of 5-14 represents a state of low disease activity and a score of <=4 represents remission.
  • Proportion of Participants Achieving 75% Improvement From Baseline in Psoriasis Area Severity Index (PASI-75) at Week 12 [ Time Frame: Baseline (Day 1), Week 12 ]
    The PASI is a composite score ranging from 0 to 72 that takes into account the degree of erythema, induration/infiltration, and desquamation (each scored from 0 to 4 separately) for each of four body regions, with adjustments for the percentage of BSA involved for each body region and for the proportion of the body region to the whole body. Higher score means worse outcome. Proportion of participants achieving 75% improvement from baseline in PASI-75 among participants with >= 3% BSA psoriatic involvement at Day 1 will be reported.
  • Proportion of Participants Achieving a Physician Global Assessment of Psoriasis of 0 or 1 and at least a 2-point Improvement From Baseline at Week 12 [ Time Frame: Baseline (Day 1), Week 12 ]
    The PGA is measured using a 0 to 4 scale with a 0 score meaning cleared and a 4 score meaning severe and a ≥ 2 grade improvement from baseline.
  • Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs and Treatment-emergent Adverse Events of Special Interests (TEAESIs) [ Time Frame: Baseline (Day 1) up to End of study (EOS) (Week 16) ]
    TEAEs are defined as adverse events (AEs) with onset at the time of or following the first exposure to NDI-034858 in this study, or medical conditions present prior to the start of treatment but increasing in severity or relationship at the time of or following the start of treatment. Serious TEAEs are defined as any untoward clinical manifestation of signs, symptoms, outcomes (related to Investigational product [IP] or not) that at any dose: resulted in death, was life-threatening, required inpatient/prolongation of hospitalization, resulted in persistent/significant disability/incapacity, congenital abnormality/birth defect, important medical event. TEAESIs are defined as investigator-reported hypersensitivity reactions, events of disordered coagulation as bleeding/hypercoagulable. Relatedness to study drug was based on Investigator's discretion.
  • Plasma Concentrations of NDI-034858 [ Time Frame: Day 1: Pre-dose,1 hour post-dose; Week 4: Pre-dose, 1 hour, and 4 hours post-dose; Week 8: Pre-dose and anytime at Week 12 ]
    Plasma concentrations of NDI-034858 will be assessed.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 9, 2021)
  • Proportion of subjects achieving at least an ACR-50 or ACR-70 response [ Time Frame: Day 1 to Week 16 ]
    The ACR-50 and ACR-70 are a composite measure defined as both improvement of 50% or 70%, respectively, in the number of tender (68) and number of swollen (66) joints, and a 50% or 70%, respectively, improvement in three of the following five criteria: patient global assessment of psoriatic arthritis, physician global assessment of psoriatic arthritis, patient pain scale, disability history questionnaire (ie, HAQ-DI) and an acute phase reactant (ie, ESR or CRP).
  • Change from baseline in tender joint count (TJC) [ Time Frame: From screening until Week 12 ]
    The TJC 68 are a total score of points assigned for presence of tenderness in the following: Temporomandibular, sternoclavicular, acromioclavicular, shoulder, elbow, wrist, hip, knee, ankle, tarsus, typically assigned 2 points each; Metacarpophalangeal, finger proximal interphalangeal, metatarsophalangeal, toe proximal interphalangeal, typically assigned 10 points each; Distal interphalangeal, typically assigned 8 points.
  • Change from baseline in swollen joint count (SJC) [ Time Frame: From screening until Week 12 ]
    The SJC 66 (SJC minus hip joints, which cannot be assessed for swelling) are a total score of points assigned for presence of swelling in the following: Temporomandibular, sternoclavicular, acromioclavicular, shoulder, elbow, wrist, knee, ankle, tarsus, typically assigned 2 points each; Metacarpophalangeal, finger proximal interphalangeal, metatarsophalangeal, toe proximal interphalangeal, typically assigned 10 points each; Distal interphalangeal, typically assigned 8 points.
  • Change from baseline in Patient Global Assessment of Psoriatic Arthritis [ Time Frame: Day 1 to Week 16 ]
    Subjects will rate their assessment of their PsA using a VAS where 0 is 'very good, no symptoms' and 100 is 'very poor, severe symptoms'.
  • Change from baseline in Patient Global Assessment of Psoriatic Arthritis pain [ Time Frame: Day 1 to Week 16 ]
    Subjects will rate their assessment of their PsA using a VAS where 0 is 'no pain' and 100 is 'most severe pain'.
  • Change from baseline in Physician Global Assessment of Psoriatic Arthritis [ Time Frame: Day 1 to Week 16 ]
    The patients' overall disease status will be assessed, taking into account signs, symptoms, and function, of all components of joint and skin which is affected at the time of the visit and will rate this overall status using a VAS scale where 0 is 'very good, asymptomatic, and no limitation of normal activities' and 100 is 'very poor, very severe symptoms which are intolerable, and inability to carry out all normal activities'.
  • Change from baseline in Health Activities Questionnaire - Disability Index (HAQ-DI) score [ Time Frame: Day 1 to Week 16 ]
    The HAQ-DI is comprised of eight domains: dressing, arising, eating, walking, hygiene, reach, grip, and activities. There are two or three questions per section. Scoring within each section is from 0 (without any difficulty) to 3 (unable to do). For each section the score given to that section is the worst score within the section (ie, if one question is scored 1 and another 2, then the score for the section is 2).
  • Change from baseline in dactylitis count [ Time Frame: Day 1 to Week 16 ]
    The dactylitis count consists of totaling the number of single digits in the hands and feet with tenderness.
  • Change from baseline in Leed's Enthesitis Index (LEI) [ Time Frame: Day 1 to Week 16 ]
    The LEI is comprised of review of six bilateral sites: Achilles tendon insertions, medial femoral condyles, and lateral epicondyles of the humerus. Tenderness at each site is quantified on a dichotomous basis: 0 means nontender and 1 means tender.
  • Change from baseline in Physician Global Assessment of Psoriasis [ Time Frame: Day 1 to Week 16 ]
    The PGA is measured using a 0 to 4 scale with a 0 score meaning cleared and a 4 score meaning severe and a ≥ 2 grade improvement from baseline.
  • Change from baseline in Disease Activity Score 28 with CRP(DAS28-CRP) [ Time Frame: Day 1 to Week 16 ]
    The DAS28-CRP describes the severity of PsA using clinical and laboratory data, specifically hsCRP. The DAS scores indicate how active a subject's psoriatic arthritis is currently and can be trended over time.
  • Incidence of AEs and TAEs [ Time Frame: Day 1 to Week 16 ]
    The safety and tolerability of NDI-034858 will be assessed.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Efficacy, Safety, and Tolerability of NDI-034858 in Participants With Active Psoriatic Arthritis
Official Title  ICMJE A Phase 2b, Randomized, Multi-Center, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Efficacy, Safety, and Tolerability of NDI-034858 in Subjects With Active Psoriatic Arthritis
Brief Summary This study is designed to evaluate the efficacy, safety, and tolerability of NDI-034858 in participants with active Psoriatic Arthritis (PsA).
Detailed Description

This is a Phase 2b, Randomized, Multi-center, Double-Blind, Placebo-Controlled, Multiple Dose Study.

Randomization to one of the treatments with NDI-034858 Dose 1, 2, 3 or placebo once daily (QD) will be based on a 1:1:1:1 scheme.

The maximum study duration per participant is approximately 20 weeks, including up to 30 days for the screening period, a 12-week treatment period, and a 4-week safety follow-up period.

Efficacy will be assessed using the ACR20 composite measure (including tender and swollen joint count, patient assessment of PsA pain visual analog scale (VAS), patient global PsA assessment VAS, physician global PsA assessment, HAQ-DI, and hsCRP) as well as the additional components. Efficacy for psoriasis among participants who have ≥ 3% BSA) involvement on Day 1, will be measured using PASI, PGAs, and BSA.

Safety will be assessed by collecting AEs, recording vital signs, performing physical examinations, and evaluating clinical laboratory and ECGs results.

Blood samples will be collected to measure plasma concentrations of NDI-034858.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description:
Treatment and randomization information will be kept confidential and will not be released to the investigator, the study staff, the contract research organization (CRO), or the sponsor's study team until after the conclusion of the study.
Primary Purpose: Treatment
Condition  ICMJE Psoriatic Arthritis
Intervention  ICMJE
  • Drug: NDI-034858
    Randomized participants will receive NDI-034858 capsule orally
    Other Name: TAK-279
  • Other: Placebo
    Randomized participants will receive placebo orally
Study Arms  ICMJE
  • Experimental: NDI-034858 study drug - Dose 1
    NDI-034858 study drug will be orally administered QD for 12 weeks
    Intervention: Drug: NDI-034858
  • Experimental: NDI-034858 study drug - Dose 2
    NDI-034858 study drug will be orally administered QD for 12 weeks
    Intervention: Drug: NDI-034858
  • Experimental: NDI-034858 study drug - Dose 3
    NDI-034858 study drug will be orally administered QD for 12 weeks
    Intervention: Drug: NDI-034858
  • Placebo Comparator: Placebo
    Placebo will be orally administered QD for 12 weeks
    Intervention: Other: 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 Completed
Actual Enrollment  ICMJE
 (submitted: March 15, 2024)
387
Original Estimated Enrollment  ICMJE
 (submitted: December 9, 2021)
260
Actual Study Completion Date  ICMJE June 2, 2023
Actual Primary Completion Date June 2, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Participant has PsA on the basis of the Classification Criteria for Psoriatic Arthritis with peripheral symptoms at the screening visit.
  • Participant has a history of PsA symptoms for ≥ 6 months prior to the screening visit.
  • Participant has ≥ 3 tender joints and ≥ 3 swollen joints at screening and Day 1 visits.
  • Participant has at least one lesion of plaque psoriasis ≥ 2 cm in diameter, nail changes characteristic of psoriasis, or a documented history of plaque psoriasis.
  • Participant has active PsA despite previous standard doses of non-steroidal anti-inflammatory drug (NSAIDs) administered for ≥ 4 weeks, or traditional disease-modifying anti-rheumatic drug (DMARDs) (including methotrexate and sulfasalazine) administered for ≥ 3 months, or tumor necrosis factor inhibitor (TNFi) agents administered for ≥ 3 months, or participants are intolerant to NSAIDs or DMARDs or TNFi agents.
  • If participant is on concurrent PsA treatments, they must be on stable doses.
  • All female participants should followed the protocol defined contraceptive method.

Exclusion Criteria:

  • Participant has other disease(s) that might confound the evaluations of benefit of NDI-034858 therapy, including but not limited to rheumatoid arthritis (RA), axial spondyloarthritis (this does not include a primary diagnosis of PsA with spondylitis), systemic lupus erythematosus, Lyme disease, or fibromyalgia.
  • Participant has a history of lack of response to any therapeutic agent targeting IL-12, IL17, and/or IL23 at approved doses after at least 12 weeks of therapy, and/or received one of these therapies within 6 months prior to baseline (Day 1).
  • Participant has a history of lack of response to > 1 therapeutic agent targeting tumor necrosis factor.
  • Participant has received infliximab, golimumab, adalimumab, or certolizumab pegol, or any biosimilar of these agents, within 8 weeks prior to baseline (Day 1).
  • Participant has received etanercept, or any biosimilar of etanercept, within 4 weeks prior to baseline (Day 1).
  • Participant has received rituximab or any immune-cell-depleting therapy within 6 months prior to baseline (Day 1).
  • Participant has received any marketed or investigational biological agent, other than those specified in other inclusion/exclusion criteria, within 12 weeks or 5 half-lives prior to baseline (Day 1).
  • Participant is currently receiving a non-biological investigational product or device or has received one within 4 weeks prior to baseline (Day 1).
  • Participant has received apremilast or other non-biologic systemic treatment for PsA within 4 weeks prior to baseline (Day 1), other than methotrexate (MTX), sulfasalazine, corticosteroids, NSAIDs, or paracetamol/acetaminophen, which are allowed at stable doses as described in Inclusion Criterion 7. For participants not receiving MTX and sulfasalazine at screening, MTX and sulfasalazine are excluded within 4 weeks prior to baseline (Day 1). Participant has received leflunomide within 8 weeks of baseline (Day 1) if no elimination procedure was followed or adhere to an elimination procedure. For participants not receiving MTX and sulfasalazine at Screening, MTX and sulfasalazine are excluded within 4 weeks prior to baseline (Day 1).
  • Participant has received intraarticular injection (including corticosteroids), intramuscular steroids, intralesional steroids, or intravenous steroids within 4 weeks prior to baseline (Day 1). For participants not receiving MTX and sulfasalazine at screening, MTX and sulfasalazine are excluded within 4 weeks prior to baseline (Day 1). For participants not receiving MTX and sulfasalazine at screening, MTX and sulfasalazine are excluded within 4 weeks prior to baseline (Day 1).
  • Participant has received high potency opioid analgesics (eg, methadone, hydromorphone, or morphine) within 2 weeks prior to baseline (Day 1).
  • Participant has used any topical medication that could affect PsA or psoriasis (including corticosteroids, retinoids, vitamin D analogues (such as calcipotriol), JAK inhibitors, or tar) within 2 weeks prior to baseline (Day 1).
  • Participant has used any systemic treatment that could affect PsA or psoriasis (including oral retinoids, immunosuppressive/immunomodulating medication, cyclosporine, oral JAK inhibitors, or apremilast) within 4 weeks prior to baseline (Day 1).
  • Participant has received any ultraviolet (UV)-B phototherapy (including tanning beds) or excimer laser within 4 weeks prior to baseline (Day 1).
  • Participant has had psoralen and UV A (PUVA) treatment within 4 weeks prior to baseline (Day 1).
  • Participant has received Chinese traditional medicine within 4 weeks prior to baseline (Day 1)
  • Participant has received any live-attenuated vaccine, including for COVID-19, within 4 weeks prior to baseline (Day 1) or plans to receive a live-attenuated vaccine during the study and up to 4 weeks or 5 half-lives of the study drug, whichever is longer, after the last study drug administration.
  • Participant is currently being treated with strong or moderate cytochrome P450 3A (CYP3A4) inhibitors, such as itraconazole or has received moderate or strong CYP3A4 inhibitors within 4 weeks prior to baseline (Day 1).
  • Participant has consumed grapefruit or grapefruit juice within 1 week prior to baseline (Day 1).
  • Participant has used tanning booths within 4 weeks prior to baseline (Day 1), has had excessive sun exposure, or is not willing to minimize natural and artificial sunlight exposure during the study.
  • Participant is a female who is breastfeeding, pregnant, or who is planning to become pregnant during the study.
  • Participant has evidence of erythrodermic, pustular, predominantly guttate psoriasis, or drug-induced psoriasis.
  • Participant has any clinically significant medical condition, evidence of an unstable clinical condition, psychiatric condition, or vital signs/physical/laboratory/ECG abnormality that would, in the opinion of the investigator, put the participant at undue risk or interfere with interpretation of study results.
  • Participant had a major surgery within 8 weeks prior to baseline (Day 1 or has a major surgery planned during the study.
  • Participant has a history of Class III or IV congestive heart failure as defined by New York Heart Association Criteria.
  • Participant has an estimated creatinine clearance of < 40 mL/min based on the Cockcroft-Gault equation or a history of renal failure.
  • Participant was hospitalized in the 3 months prior to screening for asthma, has ever required intubation for treatment of asthma, currently require oral corticosteroids for the treatment of asthma, or has required more than one short-term (≤ 2 weeks) course of oral corticosteroids for asthma within 6 months prior to baseline (Day 1).
  • Participant has a history of cancer or lymphoproliferative disease within 5 years prior to baseline (Day 1). Participants with successfully treated nonmetastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix are not to be excluded.
  • Participant has a history of fever, inflammation, or systemic signs of illness suggestive of systemic or invasive infection within 4 weeks prior to baseline (Day 1).
  • Participant has an active bacterial, viral, fungal, mycobacterial infection, or other infection (including TB or atypical mycobacterial disease), or any major episode of infection that required hospitalization or treatment with intravenous antibiotics within 12 weeks prior to baseline (Day 1), or oral antibiotics within 4 weeks prior to baseline (Day 1).
  • Participant has a history of chronic or recurrent infectious disease, including but not limited to chronic renal infection, chronic chest infection, recurrent urinary tract infection, fungal infection (with the exception of superficial fungal infection of the nailbed), or infected skin wounds or ulcers.
  • Participant has a history of an infected joint prosthesis or has received antibiotics for a suspected infection of a joint prosthesis, if that prosthesis has not been removed or replaced.
  • Participant has active herpes infection, including herpes simplex 1 and 2 and herpes zoster within 8 weeks prior to Day 1.
  • Participant has a history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the Participant's immune status (eg, history of splenectomy, primary immunodeficiency).
  • Participant has positive results for hepatitis B surface antigens (HBsAg), antibodies to hepatitis B core antigens (anti-HBc), hepatitis C virus (HCV), or human immunodeficiency virus (HIV). Samples testing positive for HCV antibodies will require polymerase chain reaction (PCR) qualitative testing for HCV RNA.
  • Participant has clinical or laboratory evidence of active or latent TB infection at screening as assessed by QuantiFERON-TB Gold (or a purified protein derivative [PPD] skin test or equivalent, or both if required per local guidelines) and chest X-ray. The PPD skin test should be utilized only when a QuantiFERON-TB Gold Test is not possible for any reason (unless local guidelines require both tests). Chest X-ray may be taken at screening or completed within 3 months prior to the screening visit, with documentation showing no evidence of infection or malignancy as read by a qualified physician.
  • Participant has a known or suspected allergy to NDI-034858 or any component of the investigational product, or any other significant drug allergy (such as anaphylaxis or hepatotoxicity).
  • Participant has a known history of clinically significant drug or alcohol abuse in the last year prior to baseline (Day 1).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (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 Czechia,   Germany,   Poland,   United States
Removed Location Countries Bulgaria
 
Administrative Information
NCT Number  ICMJE NCT05153148
Other Study ID Numbers  ICMJE 4858-202
2021-005888-52 ( EudraCT Number )
Has Data Monitoring Committee No
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: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
URL: https://vivli.org/ourmember/takeda/
Current Responsible Party Takeda
Original Responsible Party Nimbus Lakshmi, Inc.
Current Study Sponsor  ICMJE Takeda
Original Study Sponsor  ICMJE Nimbus Lakshmi, Inc.
Collaborators  ICMJE Nimbus Lakshmi, Inc.
Investigators  ICMJE
Study Director: Study Director Takeda
PRS Account Takeda
Verification Date March 2024

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