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Moderate to Severe Plaque PsoriasisPhase 2NCT04999839

Study of NDI-034858 in Participants With Moderate to Severe Plaque Psoriasis

A Phase 2 study testing NDI-034858 study drug in people with Moderate to Severe Plaque Psoriasis, run by Takeda at 69 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a Phase 2b, randomized, multicenter, double-blind, placebo-controlled, multiple-dose study designed to evaluate the efficacy, safety, and tolerability of NDI-034858 in participants with moderate to severe plaque psoriasis. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Moderate to Severe Plaque Psoriasis
What is being tested?
NDI-034858 study drug
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
259 participants
Where
69 sitesin 2 countries
Study dates
11 Aug 2021to 12 Sep 2022
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • In order to be eligible to participate in this study, a participant must meet all of the following criteria, either at the screening and Day 1 visits or only at one of the specified visits (screening or Day 1) as noted in the criterion:
  • Male or female participant aged 18 to 70 years, inclusive, at the time of consent.
  • Participant has a history of plaque psoriasis for at least 6 months prior to the screening visit.
  • Participant had no significant flare in psoriasis for at least 3 months before screening (information obtained from medical chart or participant's physician, or directly from the participant).
  • Participant has moderate to severe plaque psoriasis as defined by a PASI score ≥ 12 and a PGA score ≥ 3 at screening and Day 1.
  • Participant has plaque psoriasis covering ≥ 10% of his or her total BSA at screening and Day 1.
Show all 13Show fewer
  • Participant must be a candidate for phototherapy or systemic therapy.
  • For female participants of childbearing potential involved in any sexual intercourse that could lead to pregnancy: the participant must agree to use a highly effective contraceptive method from at least 4 weeks prior to Day 1 until at least 4 weeks after the last study product administration. Highly effective contraceptive methods include hormonal contraceptives (eg, combined oral contraceptive, patch, vaginal ring, injectable, or implant), intrauterine devices or intrauterine systems, vasectomized partner(s) (provided vasectomy was performed ≥ 4 months prior to screening), bilateral tubal ligation or occlusion, or double barrier methods of contraception (eg, male condom with cervical cap, male condom with diaphragm, and male condom with contraceptive sponge) in conjunction with spermicide.
  • Female participants of childbearing potential have had a negative serum pregnancy test at screening and negative urine pregnancy test at Day 1.
  • For male participants involved in any sexual intercourse that could lead to pregnancy, participant must agree to use one of the highly effective contraceptive methods listed in Inclusion Criterion 6, from Day 1 until at least 12 weeks after the last study product administration. If the female partner of a male participant uses any of the hormonal contraceptive methods listed above, this contraceptive method should be used by the female partner from at least 4 weeks before Day 1 until at least 12 weeks after the last study product administration.
  • Participant has a BMI within the range of 18 to 42 kg/m2, inclusive (BMI = weight [kg]/[height (m)]2), and total body weight >50 kg (110 lb).
  • Participant is willing to participate and is capable of giving informed consent. Note: Consent must be obtained prior to any study-related procedures.
  • Participant must be willing to comply with all study procedures and must be available for the duration of the study.

Who cannot join

  • A participant who meets any of the following criteria at the screening and/or Day 1 visits, as applicable, will be excluded from participation in this 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 a history of skin disease or presence of skin condition that, in the opinion of the investigator, would interfere with the study assessments.
  • Participant has immune-mediated conditions commonly associated with psoriasis, such as psoriatic arthritis, uveitis, inflammatory bowel disease, that require systemic treatment (including corticosteroids, immunosuppressants, or biologics). Note: Participants with immune-mediated conditions that do not require systemic treatment may be included in the study. Certain therapies such as NSAIDs may be permitted, but should be discussed with the Medical Monitor prior to determination of participant eligibility.
  • Participant has any clinically significant medical condition, evidence of an unstable clinical condition (eg, cardiovascular, renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, immunologic, or local active infection/infectious illness), 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.
Show all 47Show fewer
  • Participant had a major surgery within 8 weeks prior to 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 been hospitalized in the past 3 months 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 Day 1.
  • Participant has a history of cancer or lymphoproliferative disease within 5 years prior to Day 1. Participant with successfully treated non-metastatic 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 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 Day 1, or oral antibiotics within 4 weeks prior to 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 (demonstrated on physical examination and/or medical history) 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 in the opinion of the investigator (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).
  • Participant has clinical or laboratory evidence of active or latent TB infection at screening.
  • Participant with any of the following laboratory values at the screening visit:
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) values ≥ 3 times the upper limit of normal (ULN);
  • Hemoglobin < 11.0 g/dL (< 110.0 g/L);
  • White blood cell count < 3.5 x 109/L (< 3500/mm3);
  • Absolute neutrophil count of < 1.8 x 109/L (< 1800/mm3);
  • Absolute lymphocyte count of < 1.0 x 109/L (< 1000/mm3);
  • Platelet count < 100 x 109/L (< 100,000/mm3);
  • Total bilirubin ˃ 2 times the ULN.
  • Participant who have given > 50 ml of blood or plasma within 30 days of screening or > 500 mL of blood or plasma within 56 days of screening (during a clinical study or at a blood bank donation).
  • Participant has used any topical medication that could affect psoriasis (including corticosteroids, retinoids, vitamin D analogues [such as calcipotriol], JAK inhibitors, or tar) within 2 weeks prior to Day 1.
  • Participant has used any systemic treatment that could affect psoriasis (including oral, intravenous, intraarticular, intrathecal, intramuscular, or intralesional corticosteroids, oral retinoids, immunosuppressive/immunomodulating medication, methotrexate, cyclosporine, oral JAK inhibitors, or apremilast) within 4 weeks prior to Day 1.
  • Participant has received any UV-B phototherapy (including tanning beds) or excimer laser within 4 weeks prior to Day 1.
  • Participant has had PUVA treatment within 4 weeks prior to Day 1.
  • Participant has received any live-attenuated vaccine within 4 weeks prior to 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 product, whichever is longer, after the last study product administration. Note: Nonlive-attenuated vaccines or boosters for Coronavirus Disease 2019 (COVID-19) (eg, RNA-based vaccines, inactivated adenovirus-based vaccines, protein-based vaccines) are allowed during the study. The study site should follow local guidelines related to COVID-19.
  • Participant is currently receiving a nonbiological investigational product or device or has received one within 4 weeks prior to Day 1.
  • Participant has received any marketed or investigational biological agent within 12 weeks or 5 half-lives (whichever is longer) prior to Day 1 (except those listed in Exclusion Criterion 27 and 28 that are to be excluded for 6 months).
  • Participant was previously enrolled in any study with NDI-034858.
  • Participant has a history of lack of response to any therapeutic agent targeting IL-12, IL-17, and/or IL 23 (eg, ustekinumab, secukinumab, ixekizumab, brodalumab, guselkumab, tildrakizumab, risankizumab) at approved doses after at least 12 weeks of therapy, and/or received one of these therapies within 6 months prior to Day 1.
  • Participant has received rituximab or other immune-cell depleting therapy within 6 months.
  • 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 Day 1.
  • Participant is currently being treated with terbinafine, or has received terbinafine within 4 weeks prior to Day 1.
  • Participant has consumed grapefruit within 1 week prior to Day 1.
  • Participant has used tanning booths within 4 weeks prior to Day 1, has had excessive sun exposure, or is not willing to minimize natural and artificial sunlight exposure during the study.
  • 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 Day 1.
  • For participant consenting to biopsy collection only:
  • Participant has a history of an allergic reaction or significant sensitivity to lidocaine or other local anesthetics.
  • Participant has a history of hypertrophic scarring or keloid formation in scars or suture sites.
  • Participant has taken anticoagulant medication, such as heparin, low molecular weight (LMW)-heparin, warfarin, or antiplatelet agents (except low-dose aspirin ≤ 81 mg which will be allowed), within 2 weeks prior to Day 1, or has a contraindication to skin biopsies. Nonsteroidal anti-inflammatory drugs will not be considered antiplatelet agents and will be allowed.

Trial locations and contacts

69 sites in 2 countries.

69 sites in 2 countries

United States59 sites

  • Nimbus site 146

    Ann Arbor, Michigan, 48103

  • Nimbus site 109

    Arlington, Texas, 76011

  • Nimbus site 103

    Bay City, Michigan, 48706

  • Nimbus site 113

    Bellaire, Texas, 77401

  • Nimbus site 115

    Beverly, Massachusetts, 01915

  • Nimbus site 127

    Bexley, Ohio, 43209

  • Nimbus site 137

    Birmingham, Alabama, 35205

  • Nimbus site 156

    Birmingham, Alabama, 35244

  • Nimbus site 133

    Bryant, Arkansas, 72022

  • Nimbus site 110

    Charleston, South Carolina, 29407

  • Nimbus site 129

    Charlotte, North Carolina, 28277

  • Nimbus site 159

    Clarksville, Indiana, 47129

  • Nimbus site 147

    Columbus, Georgia, 31904

  • Nimbus site 145

    Columbus, Ohio, 43213

  • Nimbus site 155

    Doral, Florida, 33122

  • Nimbus site 128

    Fairborn, Ohio, 45324

  • Nimbus site 134

    Fountain Valley, California, 92708

  • Nimbus site 149

    Hialeah, Florida, 33012

  • Nimbus site 140

    Indianapolis, Indiana, 46250

  • Nimbus site 117

    Jackson, Tennessee, 38305

  • Nimbus site 131

    Katy, Texas, 77494

  • Nimbus site 136

    Lake Charles, Louisiana, 70605

  • Nimbus site 130

    Largo, Florida, 33770

  • Nimbus site 108

    Los Angeles, California, 90033

  • Nimbus site 161

    Louisville, Kentucky, 40217

  • Nimbus site 105

    Louisville, Kentucky, 40241

  • Nimbus site 150

    Macon, Georgia, 31217

  • Nimbus site 160

    Margate, Florida, 33063

  • Numbus site 114

    Metairie, Louisiana, 70006

  • Nimbus site 107

    Miami Lakes, Florida, 33014

  • Nimbus site 139

    Miami Lakes, Florida, 33014

  • Nimbus site 121

    Nashville, Tennessee, 37215

  • Nimbus site 158

    New Brighton, Minnesota, 55112

  • Nimbus site 143

    New York, New York, 10075

  • Nimbus site 141

    Norman, Oklahoma, 73071

  • Nimbus site 118

    Ocala, Florida, 34470

  • Nimbus site 154

    Overland Park, Kansas, 66210

  • Nimbus site 125

    Pittsburgh, Pennsylvania, 15123

  • Nimbus site 135

    Quincy, Massachusetts, 02169

  • Nimbus site 122

    Rockville, Maryland, 20850

  • Nimbus site 124

    Sacramento, California, 95816

  • Nimbus site 104

    San Antonio, Texas, 78213

  • Nimbus site 152

    San Antonio, Texas, 78229

  • Nimbus site 153

    San Diego, California, 92122

  • Nimbus site 111

    San Diego, California, 92123

  • Nimbus site 119

    Sandy Springs, Georgia, 30328

  • Nimbus site 148

    Santa Rosa, California, 95405

  • Nimbus site 132

    Scottsdale, Arizona, 85255

  • Nimbus site 120

    Sherman Oaks, California, 91403

  • Nimbus site 123

    Skokie, Illinois, 60077

  • Nimbus site 142

    Spokane, Washington, 99026

  • Nimbus site 157

    Sweetwater, Florida, 33172

  • Nimbus site 101

    Tampa, Florida, 33607

  • Nimbus site 102

    Tampa, Florida, 33613

  • Nimbus site 112

    Troy, Michigan, 48084

  • Nimbus site 138

    Troy, Michigan, 48084

  • Nimbus site 162

    Webster, Texas, 77598

  • Nimbus site 116

    West Palm Beach, Florida, 33406

  • Nimbus site 106

    Wilmington, North Carolina, 28405

Other trials in United States

Canada10 sites

  • Nimbus site 204

    Calgary

  • Nimbus site 206

    Calgary

  • Nimbus site 212

    Edmonton

  • Nimbus site 209

    Hamilton

  • Nimbus site 203

    Markham

  • Nimbus site 201

    Montreal

  • Nimbus site 205

    Oshawa

  • Nimbus site 210

    Peterborough

  • Nimbus site 208

    Red Deer

  • Nimbus site 202

    Waterloo

Other trials in Canada

About this study

Official title: A Phase 2b, Randomized, Multicenter, Double-blind, Placebo-controlled, Multiple-dose Study to Evaluate the Efficacy, Safety, and Tolerability of NDI-034858 in Subjects With Moderate to Severe Plaque Psoriasis

This is a Phase 2b, randomized, multicenter, double-blind, placebo-controlled, multiple-dose study designed to evaluate the efficacy, safety, and tolerability of NDI-034858 in participants with moderate to severe plaque psoriasis. This study will also evaluate the plasma concentrations of NDI-034858 and explore the immune response to NDI-034858 in participants with moderate to severe plaque psoriasis.

Read the detailed description

Approximately 259 male and female participants, aged 18 to 70 years (inclusive) were enrolled in this study. Participants were randomized to receive either one of the four doses of NDI-034858, or placebo on Day 1. The goal was to have approximately 50 participants randomized per treatment group (1:1:1:1:1 ratio) on Day 1. During the treatment period, NDI-034858 or placebo was orally administered QD for 12 weeks. The 12 week treatment period was followed by a 4-week safety follow-up period.

Being tested
NDI-034858 study drug, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NDI-034858 study drugDrug

    Also called NDI-034858, TAK-279

    NDI-034858 2 mg oral capsules.

  • NDI-034858 study drugDrug

    Also called NDI-034858, TAK-279

    NDI-034858 5 mg oral capsules.

  • NDI-034858 study drugDrug

    Also called NDI-034858, TAK-279

    NDI-034858 15 mg oral capsules.

  • NDI-034858 study drugDrug

    Also called NDI-034858, TAK-279

    NDI-034858 30 mg (2*15 mg) oral capsules.

  • PlaceboOther

    Also called Non Active Ingredient

    Placebo matched to NDI-034858 oral capsules.

Study groups in NCT04999839
Study groupRoleWhat they receive
PlaceboPlacebo comparatorParticipants received placebo matched to NDI-034858 oral capsules, once daily (QD) for up to 12 weeks.
Receives: Other: Placebo
NDI-034858 2 milligrams (mg)ExperimentalParticipants received 2 mg of NDI-034858 oral capsules, QD for up to 12 weeks.
Receives: Drug: NDI-034858 study drug
NDI-034858 5 mgExperimentalParticipants received 5 mg of NDI-034858 oral capsules, QD for up to 12 weeks.
Receives: Drug: NDI-034858 study drug
NDI-034858 15 mgExperimentalParticipants received 15 mg of NDI-034858 oral capsules, QD for up to 12 weeks.
Receives: Drug: NDI-034858 study drug
NDI-034858 30 mgExperimentalParticipants received 30 mg (2*15 mg) of NDI-034858 oral capsules, QD for up to 12 weeks.
Receives: Drug: NDI-034858 study drug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants Who Achieved at Least 75 Percent (%) Improvement From Baseline in Psoriasis Area and Severity Index (PASI-75) at Week 12

    The PASI quantifies the severity of a participant's psoriasis based on both "lesion severity" and the "percent of body surface area (BSA)" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI composite score varies in increments of 0.1 and range from 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. PASI 75 response is a binary measure defined as at least a 75% improvement in PASI score at Week 12, relative to baseline PASI score.

    Measured: Baseline, Week 12

Secondary outcomes (6)

  1. Percentage of Participants Who Achieved Physician's Global Assessment (PGA) Score of Clear (0) or Almost Clear (1) at Week 12

    The PGA is a global assessment of the current state of the disease. It is a 5-point morphological assessment of overall disease severity with scores ranging from 0 to 4, where Score 0: Clear (No signs of psoriasis; post-inflammatory hyperpigmentation may be present); Score 1: Almost clear (No thickening; normal to pink coloration; no to minimal focal scaling); Score 2: Mild (Just detectable to mild thickening; pink to light red coloration; predominantly fine scaling); Score 3: Moderate (Clearly distinguishable to moderate thickening; dull to bright red; clearly distinguishable to moderate erythema; moderate scaling); Score 4: Severe (Severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions). The percentage of participants who achieved a PGA score of clear (0) or almost clear (1) at Week 12 were reported.

    Measured: At Week 12

  2. Percentage of Participants Who Achieved at Least 90% Improvement From Baseline in Psoriasis Area and Severity Index (PASI-90) at Week 12

    The PASI quantifies the severity of a participant's psoriasis based on both "lesion severity" and the "percent of BSA" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI composite score varies in increments of 0.1 and range from 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. PASI 90 response is a binary measure defined as at least a 90% improvement in PASI score at Week 12, relative to baseline PASI score.

    Measured: Baseline, Week 12

  3. Percentage of Participants Who Achieved at Least 100% Improvement From Baseline in Psoriasis Area and Severity Index (PASI-100) at Week 12

    The PASI quantifies the severity of a participant's psoriasis based on both "lesion severity" and the "percent of BSA" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI composite score varies in increments of 0.1 and range from 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. PASI 100 response is a binary measure defined as at least a 100% improvement in PASI score at Week 12, relative to baseline PASI score.

    Measured: Baseline, Week 12

  4. Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 12

    The DLQI is a simple 10 question validated questionnaire that has been used in more than 40 different skin conditions. The DLQI is the most frequently used quality of life instrument in studies of randomized controlled trials in dermatology. Each question is scored on a four-point Likert scale: very much (3); a lot (2); a little (1); not at all (0). DLQI total score is defined as the sum of the 10 questions, ranging from 0 (not at all) to 30 (very much). Higher scores indicate more impact on quality of life of participants; and lower scores indicate less impact on the quality of life of participants.

    Measured: Baseline, Week 12

  5. Number of Participants With Treatment-emergent Adverse Event (TEAEs) and Serious TEAEs

    An adverse event (AE) means any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. TEAEs were defined as any AEs with onset date on or after the first study treatment dosing. An SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital abnormality or birth defect, an important medical event. TEAEs included both serious and non-serious AEs.

    Measured: From start of study drug administration up to Week 16

  6. Plasma Concentrations of NDI-034858 in Participants Receiving Active Treatment

    The analysis of NDI-034858 levels in plasma was performed using a validated reversed-phase Ultra High-Performance Liquid Chromatography coupled with tandem mass-spectrometry (UHPLC-MS/MS) method. Here, plasma concentrations of NDI-034858 determined at given timepoints were reported.

    Measured: Week 1: Day 1, Pre-dose and 1-hour post-dose; Week 4: Pre-dose, 1-hour and 4 hours post-dose; Week 8: Pre-dose; Week 12: Post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Aug 2021
  2. Study start11 Aug 2021
  3. Primary completion19 Aug 2022
  4. Study completion12 Sep 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
259 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04999839
Sponsor's protocol ID
4858-201
Status last verified
Sep 2023
First submitted
19 Jul 2021
Last updated
28 Sep 2023
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Elbuluk N, Armstrong AW, Vender R, Bhutani T, Green L, Ferris LK, Laquer V, Moore A, Weisman J, Zhang W, Winkelman W, Gooderham MJ. Zasocitinib (TAK-279), a Highly Selective Oral TYK2 Inhibitor, Demonstrates Skin Clearance in Patients with Moderate-to-Severe Plaque Psoriasis: Post Hoc Analyses of a Randomized Phase IIb Trial. Dermatol Ther (Heidelb). 2026 Jun;16(6):3215-3234. doi: 10.1007/s13555-026-01738-6. Epub 2026 May 16.

    PubMed 42143206

  • Armstrong AW, Gooderham M, Lynde C, Maari C, Forman S, Green L, Laquer V, Zhang X, Franchimont N, Gangolli EA, Blau J, Zhao Y, Zhang W, Srivastava B, Heap G, Papp K. Tyrosine Kinase 2 Inhibition With Zasocitinib (TAK-279) in Psoriasis: A Randomized Clinical Trial. JAMA Dermatol. 2024 Oct 1;160(10):1066-1074. doi: 10.1001/jamadermatol.2024.2701.

    PubMed 39167366

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing NDI-034858 study drug in people with Moderate to Severe Plaque Psoriasis, run by Takeda at 69 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 47 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 69 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Who Achieved at Least 75 Percent (%) Improvement From Baseline in Psoriasis Area and Severity Index (PASI-75) at Week 12 (time frame: Baseline, Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04999839, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.

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