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

NCT04999839 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 4858-201
• Study Type: interventional
• Target: 259
• Locations: 2 countries
• Sites: 69

Brief 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. 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.

Conditions

Moderate to Severe Plaque Psoriasis

Outcome Measures

Primary Outcomes (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.

  Baseline, Week 12

Secondary Outcomes (6)

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

  At Week 12

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

  Baseline, Week 12

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

  Baseline, Week 12

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

  Baseline, Week 12

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

  From start of study drug administration up to Week 16

Study Arms (5)

Placebo

PLACEBO COMPARATOR

Participants received placebo matched to NDI-034858 oral capsules, once daily (QD) for up to 12 weeks.

Other: Placebo

NDI-034858 2 milligrams (mg)

EXPERIMENTAL

Participants received 2 mg of NDI-034858 oral capsules, QD for up to 12 weeks.

Drug: NDI-034858 study drug

NDI-034858 5 mg

EXPERIMENTAL

Participants received 5 mg of NDI-034858 oral capsules, QD for up to 12 weeks.

Drug: NDI-034858 study drug

NDI-034858 15 mg

EXPERIMENTAL

Participants received 15 mg of NDI-034858 oral capsules, QD for up to 12 weeks.

Drug: NDI-034858 study drug

NDI-034858 30 mg

EXPERIMENTAL

Participants received 30 mg (2\*15 mg) of NDI-034858 oral capsules, QD for up to 12 weeks.

Drug: NDI-034858 study drug

Interventions

NDI-034858 study drug DRUG

NDI-034858 2 mg oral capsules.

Also known as: NDI-034858, TAK-279

NDI-034858 2 milligrams (mg)

Placebo OTHER

Placebo matched to NDI-034858 oral capsules.

Also known as: Non Active Ingredient

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Takeda: lead
• Innovaderm Research Inc.: collaborator
• Nimbus Lakshmi, Inc.: collaborator

Study Sites (69)

Nimbus site 137

Birmingham, Alabama, 35205, United States

Location

Nimbus site 156

Birmingham, Alabama, 35244, United States

Location

Nimbus site 132

Scottsdale, Arizona, 85255, United States

Location

Nimbus site 133

Bryant, Arkansas, 72022, United States

Location

Nimbus site 134

Fountain Valley, California, 92708, United States

Location

Nimbus site 108

Los Angeles, California, 90033, United States

Location

Nimbus site 124

Sacramento, California, 95816, United States

Location

Nimbus site 153

San Diego, California, 92122, United States

Location

Nimbus site 111

San Diego, California, 92123, United States

Location

Nimbus site 148

Santa Rosa, California, 95405, United States

Location

Nimbus site 120

Sherman Oaks, California, 91403, United States

Location

Nimbus site 155

Doral, Florida, 33122, United States

Location

Nimbus site 149

Hialeah, Florida, 33012, United States

Location

Nimbus site 130

Largo, Florida, 33770, United States

Location

Nimbus site 160

Margate, Florida, 33063, United States

Location

Nimbus site 107

Miami Lakes, Florida, 33014, United States

Location

Nimbus site 139

Miami Lakes, Florida, 33014, United States

Location

Nimbus site 118

Ocala, Florida, 34470, United States

Location

Nimbus site 157

Sweetwater, Florida, 33172, United States

Location

Nimbus site 101

Tampa, Florida, 33607, United States

Location

Nimbus site 102

Tampa, Florida, 33613, United States

Location

Nimbus site 116

West Palm Beach, Florida, 33406, United States

Location

Nimbus site 147

Columbus, Georgia, 31904, United States

Location

Nimbus site 150

Macon, Georgia, 31217, United States

Location

Nimbus site 119

Sandy Springs, Georgia, 30328, United States

Location

Nimbus site 123

Skokie, Illinois, 60077, United States

Location

Nimbus site 159

Clarksville, Indiana, 47129, United States

Location

Nimbus site 140

Indianapolis, Indiana, 46250, United States

Location

Nimbus site 154

Overland Park, Kansas, 66210, United States

Location

Nimbus site 161

Louisville, Kentucky, 40217, United States

Location

Nimbus site 105

Louisville, Kentucky, 40241, United States

Location

Nimbus site 136

Lake Charles, Louisiana, 70605, United States

Location

Numbus site 114

Metairie, Louisiana, 70006, United States

Location

Nimbus site 122

Rockville, Maryland, 20850, United States

Location

Nimbus site 115

Beverly, Massachusetts, 01915, United States

Location

Nimbus site 135

Quincy, Massachusetts, 02169, United States

Location

Nimbus site 146

Ann Arbor, Michigan, 48103, United States

Location

Nimbus site 103

Bay City, Michigan, 48706, United States

Location

Nimbus site 112

Troy, Michigan, 48084, United States

Location

Nimbus site 138

Troy, Michigan, 48084, United States

Location

Nimbus site 158

New Brighton, Minnesota, 55112, United States

Location

Nimbus site 143

New York, New York, 10075, United States

Location

Nimbus site 129

Charlotte, North Carolina, 28277, United States

Location

Nimbus site 106

Wilmington, North Carolina, 28405, United States

Location

Nimbus site 127

Bexley, Ohio, 43209, United States

Location

Nimbus site 145

Columbus, Ohio, 43213, United States

Location

Nimbus site 128

Fairborn, Ohio, 45324, United States

Location

Nimbus site 141

Norman, Oklahoma, 73071, United States

Location

Nimbus site 125

Pittsburgh, Pennsylvania, 15123, United States

Location

Nimbus site 110

Charleston, South Carolina, 29407, United States

Location

Nimbus site 117

Jackson, Tennessee, 38305, United States

Location

Nimbus site 121

Nashville, Tennessee, 37215, United States

Location

Nimbus site 109

Arlington, Texas, 76011, United States

Location

Nimbus site 113

Bellaire, Texas, 77401, United States

Location

Nimbus site 131

Katy, Texas, 77494, United States

Location

Nimbus site 104

San Antonio, Texas, 78213, United States

Location

Nimbus site 152

San Antonio, Texas, 78229, United States

Location

Nimbus site 162

Webster, Texas, 77598, United States

Location

Nimbus site 142

Spokane, Washington, 99026, United States

Location

Nimbus site 204

Calgary, Canada

Location

Nimbus site 206

Calgary, Canada

Location

Nimbus site 212

Edmonton, Canada

Location

Nimbus site 209

Hamilton, Canada

Location

Nimbus site 203

Markham, Canada

Location

Nimbus site 201

Montreal, Canada

Location

Nimbus site 205

Oshawa, Canada

Location

Nimbus site 210

Peterborough, Canada

Location

Nimbus site 208

Red Deer, Canada

Location

Nimbus site 202

Waterloo, Canada

Location

Related Publications (1)

• 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.

  PMID: 39167366 DERIVED

Related Links

• To obtain more information on the study, click here/on this link

Results Point of Contact

• Title: Study Director
• Organization: Takeda

TrialDisclosures@takeda.com

+1-877-825-3327

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2021
• First Posted: August 11, 2021
• Study Start: August 11, 2021
• Primary Completion: August 19, 2022
• Study Completion: September 12, 2022
• Last Updated: September 28, 2023
• Results First Posted: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, 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.

Locations

CA (10); US (59)