Last updated 13 days ago
Safety and Efficacy of RAP-103 to Improve Severity and Quality of Life on Moderate to Severe Psoriasis in Subjects
90 patients around the world
Available in Mexico
Safety and Efficacy of RAP-103 in dose of 400mg/day/one dose a day, 200mg/day twice dose
a day, or placebo administrated for 8 weeks, to improve severity and quality of life on
moderate to severe psoriasis in subjects 18y to 70y: Randomized, double blind, phase 2,
Proof of Concept, placebo controlled clinical trial. Primary Aim: To assess the effect
over 8 weeks of oral RAP-103 (Dose 400mg/day/one dose a day, 200mg/day twice dose a day),
or placebo on Psoriasis Area and Severity Index (PASI)75 or static Physician's Global
Assessment (sPGA) score of 0 or 1; Secondary Aims: To assess the effect over 8 weeks of
oral RAP-103 (Dose 400mg/day/one dose a day, 200mg/day twice dose a day), or placebo on
secondary clinical improvement on PASI50, PASI90, PASI100, Scalp-specific Physician's
Global Assessment (Ss-PGA) 0/1 with at least a 2-point improvement among patients with a
baseline ss-PGA ≥3, sPGA 0, PSSD symptom score of 0 among patients with baseline score
≥1, Dermatology Life Quality Index (DLQI) 0/1 at Week 4 and 8 among patients with
baseline DLQI ≥2, adjusted by transcriptomics profile (post-hoc analysis), Percentage of
subjects which achieve The Minimum Clinically Important Difference (MCID) on DLQI (a
≥4-point reduction from baseline) at Week 4 and 8, Frequency of solicited and unsolicited
adverse events (SAEs and USAEs) (Medra), and Changes on inflammatory and
anti-inflammatory cytokine levels during treatment (IL-17, IL-23, IL-6, TNF-alpha, IL1-b,
IL-10). Adults 18 years to 70y of age with moderate to severe plaque psoriasis who
fulfill the inclusion criteria will be included in the study. Patients with a history of
prior therapy, including biologic therapy, could be included after specified washout
periods before randomization. Subjects will be included in 3 different groups: A) Group 1
to receive 400mg/day/oral/one dose a day of RAP-103 for 8weeks, B) Group 2 to receive
200mg/day/oral/twice dose a day of RAP-103 for 8weeks and C) Group 3 to receive Placebo
for group for 400mg/day/oral/one dose a day 8weeks
o Group 3 to receive Placebo for group for 200mg/day/oral/twice dose a day for 8weeks.
Throughout the trial, patients, investigators, and sponsors providing oversight remained
blinded to treatment assignments. After completion of the 6-week period, eligible
patients will be invited to enter to our full RCT phase 2, when they have at least 6
weeks without using RAP103 (washout period). The collection of nonserious AEs will start
at initiation of study treatment until the final study visit. All SAEs will be collected
from the date of the patient's written consent until 30 days after the final dose of the
study drug or patient's participation in the study if the last scheduled visit occurred
at a later time. The AEs of interest will include malignancies, infections (serious,
opportunistic, fungal, tuberculosis, and herpes zoster), thromboembolic (arterial and
venous) events, major adverse cardiovascular events (MACE; cardiovascular death, nonfatal
myocardial infarction, and stroke), and skin events (acne and folliculitis). Solicited
AEs will include select infection AEs, certain cardiovascular events, and suicidal
ideation and behavior. All AEs will be coded according to the Medical Dictionary for
Regulatory Activities (MedDRA, version 28.0).
Clarent Biopharma, Inc.
1Research sites
90Patients around the world
This study is for people with
Psoriasis
Requirements for the patient
To 70 Years
All Gender
Medical requirements
- Signed written informed consent.Patients must be willing to participate in the study and sign the informed consent form.Type of patient and target disease characteristics.Men and women, diagnosed with stable plaque psoriasis for 6 months or more. Stable psoriasis is defined as no morphology changes or significant flares of disease activity, in the opinion of the investigator.Deemed by the investigator to be a candidate for systemic therapy.≥10% of body surface area (BSA) involvement at screening visit and Day 1.Psoriasis Area and Severity Index (PASI) score ≥12, and static Physician's Global Assessment (sPGA) ≥3 at screening visit and Day 1.Age and reproductive status.Men and women aged 18 years to 70 years at the time of screening visit.Women of childbearing potential (WOCBP) must have a negative serum pregnancy test at screening visit, and a negative urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin within 24 hours prior to the start of study drug.Women must not be pregnant, lactating, breastfeeding, or planning pregnancy during the study period.Women of childbearing potential must agree to correctly use a highly effective method(s) of contraception for the duration of treatment plus 30 days for a total of 33 days post-treatment completion. WOCBP who are continuously not heterosexually active are exempt from contraceptive requirements, but must still undergo pregnancy testing as described in this protocol.Male patients who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study treatment(s) plus 5 half-lives of the study treatment for a total of 3 days post-treatment completion. Additionally, male patients must be willing to refrain from sperm donation during this time.Investigators shall counsel WOCBP, and male patients who are sexually active with WOCBP, on the importance of pregnancy prevention and the implications of an unexpected pregnancy. Investigators shall advise on the use of highly effective methods of contraception, which have a failure rate of <1% when used consistently and correctly.
- Use of phototherapy 4 weeks or less prior randomization.Infectious/immune-related exclusions.History or evidence of outpatient active infection and/or febrile illness within 7 days prior to Day 1.History of serious bacterial, fungal, or viral infection requiring hospitalization and intravenous antimicrobial treatment within 60 days prior to Day 1.Any untreated bacterial infection within 60 days prior to Day 1.Any ongoing evidence of chronic bacterial infection.Any history of proven infection of a joint prosthesis in which the prosthesis was not removed or replaced, or received antibiotics for suspected infection of a joint prosthesis in which the prosthesis was not removed or replaced.Received live vaccines within 60 days prior to Day 1, or plans to receive a live vaccine during the study, or within 60 days after completing study treatment.Presence of herpes zoster lesions at screening or Day 1.History of serious herpes zoster or serious herpes simplex infection.Evidence of, or positive test for, hepatitis B virus at screening.Evidence of, or positive test for, hepatitis C virus (HCV) at screening.Positive for human immunodeficiency virus by antibody testing at screening.Any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the patient's immune status.Any of the following tuberculosis (TB) criteria.History of active TB prior to screening visit, regardless of completion of adequate treatment.Signs or symptoms of active TB during screening, as judged by the investigator.Any imaging of the chest obtained during the screening period, or any time within 6 months prior to screening with documentation, showing evidence of current active or history of active pulmonary TB.Latent TB infection (LTBI) defined as positive interferon gamma release assay (IGRA), by QuantiFERON-TB Gold testing at screening, in the absence of clinical manifestations.Patient is eligible if there are no current signs or symptoms of active TB and patient has received adequate documented treatment for LTBI within 5 years of screening or has initiated prophylactic treatment for LTBI per local guidelines and is rescreened after 1 month of treatment.An IGRA test that is indeterminate must be retested for confirmation. If the second test is again indeterminate, the patient will be excluded from the study. If the retest is positive, the patient should be treated as having LTBI. If the retest is negative, the patient may be eligible provided no other exclusion criteria for TB are met.Medical history and concurrent diseases.Any major surgery within 8 weeks prior to Day 1, or any planned surgery for the first 52 weeks of the study.Has donated blood >500 mL within 4 weeks prior to Day 1, or plans to donate blood during the course of the study.Drug or alcohol abuse, as determined by the investigator, within 6 months prior to Day 1.Medical marijuana or prescription marijuana taken for medicinal reasons.Any major illness/condition or evidence of an unstable clinical condition that, in the investigator's judgment or after consultation with the medical monitor, will substantially increase the risk to the patient if he or she participates in the study.Unstable cardiovascular disease, defined as a recent clinical cardiovascular event in the last 3 months prior to screening, or a cardiac hospitalization within 3 months prior to screening.Has uncontrolled arterial hypertension characterized by a systolic blood pressure (BP) >160 mm Hg or diastolic BP >100 mm Hg.Determined by 2 consecutive elevated readings. If an initial BP reading exceeds this limit, the BP may be repeated once after the patient has rested sitting for ≥10 minutes. If the repeat value is less than the criterion limits, the second value may be accepted.Class III or IV congestive heart failure by New York Heart Association Criteria.Has cancer or history of cancer or lymphoproliferative disease within the previous 5 years.Any uncontrolled psychiatric illness judged as clinically significant by the investigator during screening or at Day 1.Prior exposure to investigational product on the last 6 months.If the patient has received biologics previously, the following exclusion criteria for washout will apply. Antibodies to IL-12, IL-17, or IL-23 (eg, ustekinumab, secukinumab, tildrakizumab, ixekizumab, or guselkumab) within 6 months of Day 1 prior randomization; Tumor necrosis factor inhibitor(s) (eg, etanercept, adalimumab, infliximab, certolizumab) within 2 months of Day 1; Agents that modulate integrin pathways to impact lymphocyte trafficking (eg, natalizumab), or agents that modulate B cells or T cells (eg, alemtuzumab, abatacept, or visilizumab) within 3 months of Day 1; or Rituximab within 6 months of Day 1Has received systemic nonbiologic psoriasis medications and/or any systemic immunosuppressant therapy (including, but not limited to, methotrexate, azathioprine, cyclosporine, Janus kinase inhibitors, 6-thioguanine, mercaptopurine, mycophenolate mofetil, hydroxyurea, tacrolimus, oral or injectable corticosteroids, retinoids, 1,25-dihydroxy vitamin D3 and analogues, psoralens, sulfasalazine, or fumaric acid derivatives) within 4 weeks prior to Day 1Has used leflunomide within 6 months prior to Day 1.Has used opioid analgesics within 4 weeks prior to Day 1.Has received lithium, antimalarials, or intramuscular gold within 4 weeks of the first administration of any study medication.Has used any strong CYP450 inducers within 4 weeks prior to Day 1.Has used topical medications/treatments that could affect psoriasis evaluation within 2 weeks prior to Day 1.Use of shampoos containing corticosteroids, coal tar, >3% salicylic acid, or vitamin D3 analogues within 2 weeks prior to Day 1.Has received an experimental antibody or experimental biologic therapy within the previous 6 months.Laboratory evaluations.Absolute white blood cell count <3000/mm3.Absolute lymphocyte count <500/mm3.Absolute neutrophil count <1000/mm3.Platelet count <100,000/mm3.Hemoglobin <9 g/dL.Alanine aminotransferase and/or aspartate aminotransferase >3 × upper limit of normal (ULN).Total, unconjugated, and/or conjugated bilirubin >2 × ULN.Thyroid-stimulating hormone outside the normal reference range AND free T4 (thyroxine) or T3 (triiodothyronine) outside the normal reference range.Electrocardiogram abnormalities that are considered clinically significant and would pose an unacceptable risk to the patient if participating in the study.Renal impairment based on an estimated glomerular filtration rate <45 mL/min.
Sites
Innovación y Desarrollo en Ciencias de la Salud - IDeCSa
StudyRAP103-Pso
SponsorClarent Biopharma, Inc.
Study typeInterventional
Conditions
Psoriasis
Requirements
To 70 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT07204639
