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

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ClinicalTrials.gov Identifier: NCT04999839
Recruitment Status : Recruiting
First Posted : August 11, 2021
Last Update Posted : October 27, 2021
Sponsor:
Collaborator:
Innovaderm Research Inc.
Information provided by (Responsible Party):
Nimbus Therapeutics ( Nimbus Lakshmi, Inc. )

Tracking Information
First Submitted Date  ICMJE July 19, 2021
First Posted Date  ICMJE August 11, 2021
Last Update Posted Date October 27, 2021
Actual Study Start Date  ICMJE August 18, 2021
Estimated Primary Completion Date August 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 2, 2021)
Proportion of subjects achieving Psoriasis Area and Severity Index (PASI-75) [ Time Frame: Week 12 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 2, 2021)
  • Incidence of adverse events [ Time Frame: 12 weeks ]
  • Measurement of plasma concentrations of NDI-034858 in subjects receiving active treatment. [ Time Frame: at Weeks 2, 4, 8, and 12 ]
  • Proportion of subjects achieving Psoriasis Area and Severity Index (PASI-50) [ Time Frame: at Weeks 2, 4, 8, and 12 ]
  • Proportion of subjects achieving Psoriasis Area and Severity Index (PASI-75) [ Time Frame: at Weeks 2, 4, and 8 ]
  • Proportion of subjects achieving Psoriasis Area and Severity Index (PASI-90) [ Time Frame: at Weeks 2, 4, 8, and 12 ]
  • Proportion of subjects achieving Psoriasis Area and Severity Index (PASI-100) [ Time Frame: at Weeks 2, 4, 8, and 12 ]
  • Change from baseline in Psoriasis Area and Severity Index (PASI) [ Time Frame: at Weeks 2, 4, 8, and 12 ]
  • Percent change from baseline in Psoriasis Area and Severity Index (PASI) [ Time Frame: at Weeks 2, 4, 8, and 12 ]
    The Psoriasis Areas and Severity Index (PASI) is a measurement tool used to assess the severity of psoriasis, monitor the progression of the condition, and evaluate the effectiveness of treatment. It is calculated using the redness, thickness, and scaring of psoriasis plaques and the surface area of the body affected by the plaques. The score ranges from 0-72, with higher scores indicating greater severity of psoriasis.
  • Change from baseline in Physician Global Assessment (PGA) [ Time Frame: at Weeks 2, 4, 8, and 12 ]
  • Proportion of subjects achieving a Physician Global Assessment (PGA) of clear (0) or almost clear (1) [ Time Frame: at Weeks 2, 4, 8, and 12 ]
    The Physician's Global Assessment (PGA) is a scale used to assess the severity of psoriasis, monitor the progression of the condition, and evaluate the effectiveness of treatment. It is determined by assessing overall psoriasis severity using redness, thickness, and scaling of plaques. The score ranges from 0 (clear) to 4 (severe).
  • Proportion of subjects with at least a 2-grade decrease from baseline in Physician Global Assessment (PGA) [ Time Frame: at Weeks 2, 4, 8, and 12 ]
  • Change from baseline in pruritus numeric rating scale (NRS) [ Time Frame: at Weeks 2, 4, 8, and 12 ]
    The pruritus Numeric Rating Scale (NRS) is a scale used to assess the severity of itching as reported by the patient. Patients are asked to assign a numerical score representing the worst intensity of itching over the last 24 hours on a scale from 0 to 10, with 0 indicating no symptoms and 10 indicating the worst imaginable symptoms.
  • Proportion of subjects with at least a 4-point decrease from baseline in pruritus numeric rating scale (NRS) [ Time Frame: at Weeks 2, 4, 8, and 12 ]
  • Change from baseline in Dermatology Life Quality Index (DLQI) [ Time Frame: at Weeks 4, 8, and 12 ]
    The Dermatology Life Quality Index Questionnaire (DLQI) is a 10-question questionnaire used to assess how skin conditions have affected a patient's life over the past week. Each question is scored from 0 to 3 and the scores are added, giving a possible score range from 0 (meaning no impact of skin disease on quality of life) to 30 (meaning extremely large impact on quality of life).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of NDI-034858 in Subjects With Moderate to Severe Plaque Psoriasis
Official Title  ICMJE 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
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 subjects 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 subjects with moderate to severe plaque psoriasis.
Detailed Description Approximately 250 male and female subjects, aged 18 to 70 years (inclusive) will be enrolled in this study. Subjects will be randomized to receive either one of the four doses of NDI-034858, or placebo on Day 1. The goal is to have approximately 50 subjects randomized per treatment group (1:1:1:1:1 ratio) on Day 1. During the treatment period, NDI-034858 or placebo will be orally administered QD for 12 weeks. The 12 week treatment period will be followed by a 4-week safety follow-up period.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Moderate to Severe Plaque Psoriasis
Intervention  ICMJE
  • Drug: NDI-034858 study drug
    Dosage Level - 1
    Other Name: NDI-034858
  • Drug: NDI-034858 study drug
    Dosage Level - 2
    Other Name: NDI-034858
  • Drug: NDI-034858 study drug
    Dosage Level - 3
    Other Name: NDI-034858
  • Drug: NDI-034858 study drug
    Dosage Level - 4
    Other Name: NDI-034858
  • Other: Placebo
    Placebo
    Other Name: Non Active Ingredient
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Placebo of NDI-034858 study drug - Approximately 50 subjects will receive placebo, orally administered QD for 12 weeks.
    Intervention: Other: Placebo
  • Experimental: NDI-034858 study drug - Dose 1
    NDI-034858 study drug - orally administered QD for 12 weeks.
    Interventions:
    • Drug: NDI-034858 study drug
    • Other: Placebo
  • Experimental: NDI-034858 study drug - Dose 2
    NDI-034858 study drug - orally administered QD for 12 weeks.
    Interventions:
    • Drug: NDI-034858 study drug
    • Other: Placebo
  • Experimental: NDI-034858 study drug - Dose 3
    NDI-034858 study drug - orally administered QD for 12 weeks.
    Interventions:
    • Drug: NDI-034858 study drug
    • Other: Placebo
  • Experimental: NDI-034858 study drug - Dose 4
    NDI-034858 study drug - orally administered QD for 12 weeks.
    Intervention: Drug: NDI-034858 study drug
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 2, 2021)
250
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 31, 2022
Estimated Primary Completion Date August 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

In order to be eligible to participate in this study, a subject 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:

  1. Male or female subject aged 18 to 70 years, inclusive, at the time of consent.
  2. Subject has a history of plaque psoriasis for at least 6 months prior to the screening visit.
  3. Subject had no significant flare in psoriasis for at least 3 months before screening (information obtained from medical chart or subject's physician, or directly from the subject).
  4. Subject has moderate to severe plaque psoriasis as defined by a PASI score ≥ 12 and a PGA score ≥ 3 at screening and Day 1.
  5. Subject has plaque psoriasis covering ≥ 10% of his or her total BSA at screening and Day 1.
  6. Subject must be a candidate for phototherapy or systemic therapy.
  7. For female subjects of childbearing potential involved in any sexual intercourse that could lead to pregnancy: the subject 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), tubal ligation, 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.
  8. Female subjects of childbearing potential have had a negative serum pregnancy test at screening and negative urine pregnancy test at Day 1.
  9. For male subjects involved in any sexual intercourse that could lead to pregnancy, subject 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 subject 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.
  10. Subject has a BMI within the range of 18 to 38 kg/m2, inclusive {BMI = weight (kg)/[height (m)]2}, and total body weight >50 kg (110 lb).
  11. Subject is willing to participate and is capable of giving informed consent. Note: Consent must be obtained prior to any study-related procedures.
  12. Subjects must be willing to comply with all study procedures and must be available for the duration of the study.

Exclusion Criteria:

A subject 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:

  1. Subject is a female who is breastfeeding, pregnant, or who is planning to become pregnant during the study.
  2. Subject has evidence of erythrodermic, pustular, predominantly guttate psoriasis, or drug induced psoriasis.
  3. Subject has a history of skin disease or presence of skin condition that, in the opinion of the investigator, would interfere with the study assessments.
  4. Subject 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).
  5. Subject 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 subject at undue risk or interfere with interpretation of study results.
  6. Subject had a major surgery within 8 weeks prior to Day 1 or has a major surgery planned during the study.
  7. Subject has a history of Class III or IV congestive heart failure as defined by New York Heart Association Criteria.
  8. Subject 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.
  9. Subject has a history of cancer or lymphoproliferative disease within 5 years prior to Day 1. Subjects 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.
  10. Subject has a history of fever, inflammation, or systemic signs of illness suggestive of systemic or invasive infection within 4 weeks prior to Day 1.
  11. Subject 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.
  12. Subject 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.
  13. Subject 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.
  14. Subject 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.
  15. Subject has a history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the subject's immune status in the opinion of the investigator (eg, history of splenectomy, primary immunodeficiency).
  16. Subject has positive results for HBsAg, anti-HBc, HCV, or HIV.
  17. Subject has clinical or laboratory evidence of active or latent TB infection at screening.
  18. Subjects 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).
  19. Subject 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.
  20. Subject has used any systemic treatment that could affect psoriasis (including corticosteroids, oral retinoids, immunosuppressive/immunomodulating medication, methotrexate, cyclosporine, oral JAK inhibitors, or apremilast) within 4 weeks prior to Day 1.
  21. Subject has received any UV-B phototherapy (including tanning beds) or excimer laser within 4 weeks prior to Day 1.
  22. Subject has had PUVA treatment within 4 weeks prior to Day 1.
  23. Subject 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.
  24. Subject is currently receiving a nonbiological investigational product or device or has received one within 4 weeks prior to Day 1.
  25. Subject 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).
  26. Subject 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.
  27. Subject has received rituximab or other immune-cell depleting therapy within 6 months.
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: Study Coordinator 857-999-2009 clinical@nimbustx.com
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04999839
Other Study ID Numbers  ICMJE 4858-201
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: No
Responsible Party Nimbus Therapeutics ( Nimbus Lakshmi, Inc. )
Study Sponsor  ICMJE Nimbus Lakshmi, Inc.
Collaborators  ICMJE Innovaderm Research Inc.
Investigators  ICMJE
Study Director: Bhaskar Srivastava, MD Nimbus Lakshmi, Inc.
PRS Account Nimbus Therapeutics
Verification Date October 2021

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