Klinische Studien Nct Page

Summary
EudraCT Number:2022-003056-14
Sponsor's Protocol Code Number:VTX958-203
National Competent Authority:Bulgarian Drug Agency
Clinical Trial Type:EEA CTA
Trial Status:Ongoing
Date on which this record was first entered in the EudraCT database:2023-03-15
Trial results
A. Protocol Information
A.1Member State ConcernedBulgarian Drug Agency
A.2EudraCT number2022-003056-14
A.3Full title of the trial
A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VTX958 in Patients with Active Psoriatic Arthritis
A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
VTX958 versus Placebo for the Treatment of Active Psoriatic Arthritis
A.4.1Sponsor's protocol code numberVTX958-203
A.5.4Other Identifiers
Name:US FDA INDNumber:161407
A.7Trial is part of a Paediatric Investigation Plan No
A.8EMA Decision number of Paediatric Investigation Plan
B. Sponsor Information
B.Sponsor: 1
B.1.1Name of SponsorVentyx Biosciences, Inc
B.1.3.4CountryUnited States
B.3.1 and B.3.2Status of the sponsorCommercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1Name of organisation providing supportVentyx Biosciences, Inc
B.4.2CountryUnited States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1Name of organisationVentyx Biosciences, Inc
B.5.2Functional name of contact pointVentyx Clinical Trial
B.5.3 Address:
B.5.3.1Street Address662 Encinitas Blvd, Suite 250
B.5.3.2Town/ cityEncinitas
B.5.3.3Post codeCA 92024
B.5.3.4CountryUnited States
B.5.4Telephone number0018884115176
B.5.6E-mailclinicaltrials@ventyxbio.com
D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3IMP RoleTest
D.2 Status of the IMP to be used in the clinical trial
D.2.1IMP to be used in the trial has a marketing authorisation No
D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
D.2.5.1Orphan drug designation number
D.3 Description of the IMP
D.3.2Product code VTX958
D.3.4Pharmaceutical form Film-coated tablet
D.3.4.1Specific paediatric formulation No
D.3.7Routes of administration for this IMPOral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8INN - Proposed INNVTX-958.Adipate
D.3.9.2Current sponsor codeVTX-958.Adipate
D.3.9.3Other descriptive nameVTX-958.Adipate
D.3.9.4EV Substance CodeSUB295145
D.3.10 Strength
D.3.10.1Concentration unit mg milligram(s)
D.3.10.2Concentration typeequal
D.3.10.3Concentration number50
D.3.11 The IMP contains an:
D.3.11.1Active substance of chemical origin Yes
D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
The IMP is a:
D.3.11.3Advanced Therapy IMP (ATIMP) No
D.3.11.3.1Somatic cell therapy medicinal product No
D.3.11.3.2Gene therapy medical product No
D.3.11.3.3Tissue Engineered Product No
D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
D.3.11.5Radiopharmaceutical medicinal product No
D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
D.3.11.7Plasma derived medicinal product No
D.3.11.8Extractive medicinal product No
D.3.11.9Recombinant medicinal product No
D.3.11.10Medicinal product containing genetically modified organisms No
D.3.11.11Herbal medicinal product No
D.3.11.12Homeopathic medicinal product No
D.3.11.13Another type of medicinal product No
D.IMP: 2
D.1.2 and D.1.3IMP RoleTest
D.2 Status of the IMP to be used in the clinical trial
D.2.1IMP to be used in the trial has a marketing authorisation No
D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
D.2.5.1Orphan drug designation number
D.3 Description of the IMP
D.3.2Product code VTX958
D.3.4Pharmaceutical form Film-coated tablet
D.3.4.1Specific paediatric formulation No
D.3.7Routes of administration for this IMPOral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8INN - Proposed INNVTX-958.Adipate
D.3.9.2Current sponsor codeVTX-958.Adipate
D.3.9.3Other descriptive nameVTX-958.Adipate
D.3.9.4EV Substance CodeSUB295145
D.3.10 Strength
D.3.10.1Concentration unit mg milligram(s)
D.3.10.2Concentration typeequal
D.3.10.3Concentration number125
D.3.11 The IMP contains an:
D.3.11.1Active substance of chemical origin Yes
D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
The IMP is a:
D.3.11.3Advanced Therapy IMP (ATIMP) No
D.3.11.3.1Somatic cell therapy medicinal product No
D.3.11.3.2Gene therapy medical product No
D.3.11.3.3Tissue Engineered Product No
D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
D.3.11.5Radiopharmaceutical medicinal product No
D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
D.3.11.7Plasma derived medicinal product No
D.3.11.8Extractive medicinal product No
D.3.11.9Recombinant medicinal product No
D.3.11.10Medicinal product containing genetically modified organisms No
D.3.11.11Herbal medicinal product No
D.3.11.12Homeopathic medicinal product No
D.3.11.13Another type of medicinal product No
D.8 Information on Placebo
D.8 Placebo: 1
D.8.1Is a Placebo used in this Trial?Yes
D.8.3Pharmaceutical form of the placeboFilm-coated tablet
D.8.4Route of administration of the placeboOral use
E. General Information on the Trial
E.1 Medical condition or disease under investigation
E.1.1Medical condition(s) being investigated
Active Psoriatic Arthritis
E.1.1.1Medical condition in easily understood language
Active Psoriatic Arthritis
E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
MedDRA Classification
E.1.2 Medical condition or disease under investigation
E.1.2Version 21.0
E.1.2Level LLT
E.1.2Classification code 10037160
E.1.2Term Psoriatic arthritis
E.1.2System Organ Class 100000004859
E.1.3Condition being studied is a rare disease No
E.2 Objective of the trial
E.2.1Main objective of the trial
• To evaluate the differences in proportions of participants achieving composite 20% ACR20 clinical response after 16 weeks of treatment with VTX958 compared with placebo.
• To assess the safety and tolerability of VTX958 in participants with PsA.
E.2.2Secondary objectives of the trial
To compare the efficacy of VTX958 versus placebo on improvement of PsA following treatment for up to 16 weeks.
E.2.3Trial contains a sub-study No
E.3Principal inclusion criteria
1. Men or women, aged 18 to 75 years, inclusive, at the time of consent.
2. Body mass index within the range of 18 to 40 kg/m2, inclusive, and total body weight > 50 kg (110 lb).
3. Capable of giving signed informed consent.
4. Diagnosis of PsA with onset ≥ 6 months before Screening, and who meet the CASPAR at Screening.
5. Must be negative for rheumatoid factor and anti-CCP antibodies.
6. Must have a documented history or active signs of at least one of the following at Screening:
a. At least one confirmed lesion of plaque psoriasis of at least 2 cm,
b. Nail changes attributed to psoriasis.
7. Active PsA as defined by ≥ 3 swollen joints (SJC66) and ≥ 3 tender joints (TJC68) at Screening and Day 1; these need not be the same joints at Screening and Day 1.
8. Demonstrated inadequate response to, loss of response to, or intolerance to at least one of the following therapies:
a. Conventional nonbiologic DMARDs (eg, methotrexate, leflunomide, sulfasalazine, or hydroxychloroquine), or apremilast,
b. NSAIDs,
c. Corticosteroids.
9. Participant either (i) did not have prior exposure to biologics (biologic-naïve) or (ii) experienced treatment failure with or intolerance to 1 TNFi or 1 IL-17 inhibitor. Failure is defined as lack of response or loss of response with ≥ 12 weeks of therapy with an approved dose of a TNFi or IL-17 inhibitor, as judged by the investigator. Failure must have occurred ≥ 8 weeks prior to Day 1 for TNFi and ≥ 12 weeks prior to Day 1 for an IL-17 inhibitor.
10. Participants are permitted to receive the following medications if doses and frequency are stable for ≥ 2 weeks prior to Day 1 and they agree to continue using them at the same dosage during the study:
a. NSAIDs if dose is consistent with labeling recommendations for pain,
b. Acetaminophen (≤ 4 g/day)/paracetamol,
c. Oral corticosteroids (≤ 10 mg/day prednisone equivalent),
d. Concurrent topical therapy for plaque psoriasis.
11. If taking a conventional nonbiologic DMARD (eg, methotrexate, sulfasalazine, hydroxychloroquine, leflunomide; excludes apremilast), participants can continue using 1 DMARD provided it has been used for ≥ 12 weeks prior to Day 1 with a stable dose and frequency for ≥ 4 weeks prior to Day 1, at the same dosage during the study. As follows:
a. Methotrexate ≤ 25 mg/week
b. Leflunomide ≤ 20 mg/day
c. Sulfasalazine ≤ 3 g/day
d. Hydroxychloroquine ≤ 400 mg/day
If a conventional nonbiologic DMARD is given during the 16-week Treatment Period, the dose may be adjusted during the LTE Treatment Period.
12. Women must meet either (a) or (b) of the following criteria and men must meet criterion (c) to qualify for the study:
a. A woman who is not of childbearing potential must meet 1 of the following:
•i. Postmenopausal, defined as no menses for 12 months without an alternative medical cause, and an FSH test with a result ≥ 30 mIU/mL, confirming nonchildbearing potential.
•ii. Permanent sterilization procedure, such as hysterectomy, bilateral salpingectomy, or bilateral oophorectomy.
b. A nonpregnant woman of childbearing potential must agree to use a highly effective contraception method that can achieve a failure rate of less than 1% per year when used consistently and correctly. The highly effective contraception must be used through the duration of the study and for 30 days after the last dose of study product. The following are considered highly effective birth control methods:
•Combined (estrogen- and progesterone-containing) hormonal contraception associated with inhibition of ovulation, which may be oral, intravaginal, or transdermal,
•Progesterone-only hormonal contraception associated with inhibition of ovulation, which may be oral, injected, or implanted,
•Intrauterine device,
•Intrauterine hormone-releasing system,
•Bilateral tubal occlusion,
•Vasectomized partner, provided that the partner is the sole sexual partner of the woman of childbearing potential study participant and the vasectomized partner has received medical assessment of the surgical success,
•Sexual abstinence (complete sexual abstinence, defined as refraining from heterosexual intercourse for the entire period of risk associated with study products). The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the participant. Periodic abstinence (calendar, symptothermal, post-ovulation methods) is not acceptable.
c. A man with a pregnant or nonpregnant partner who is a woman of childbearing potential must agree to use condoms through the duration of the study and for 90 days after the last dose of study product.
d. Female participants must agree to not have egg retrieval from Day 1 until at least 30 days after the last dose of study product. Male participants must refrain from donating sperm from Day 1 until at least 90 days after the last dose of study product.
E.4Principal exclusion criteria
1.Has non-plaque psoriasis at Screening or Day 1.
2.Has any disorder that, in the opinion of the investigator, would interfere with the study assessments.
3.Has a history or evidence of active infection and/or febrile illness ≤ 7 days prior to Day 1.
4.Has a history of serious infections requiring hospitalization and/or intravenous antibiotic ≤ 12 weeks prior to Day 1, or any infection requiring oral antibiotic ≤ 4 weeks prior to Day 1.
5.Has a history of chronic or recurrent infectious disease.
6.Has a history of infected prosthesis or has received antibiotics for a suspected infection of a joint prosthesis if that prosthesis has not been removed or replaced.
7.Has an active herpes simplex infection.
8.Has a known immune deficiency or is immunocompromised.
9.Has hepatitis B infection:
•Acute or chronic hepatitis B infection, or
•A positive result for HBV at Screening.
10.Has hepatitis C infection:
•Current hepatitis C infection, or
•A positive result for HCV at Screening.
11.Has current HIV infection or AIDS, or positive HIV antibody at Screening.
12.Has active latent TB infection at Screening. History of untreated or inadequately treated latent TB infection.
13.Has had previous exposure to VTX958 or any other TYK2 inhibitor in any study.
14.Has had prior treatment with ustekinumab, tildrakizumab, risankizumab, guselkumab, or cyclophosphamide.
15.Has had treatment with secukinumab, bimekizumab, and ixekizumab < 12 weeks prior to Day 1.
16.Has had treatment with any experimental therapy or new investigational agent ≤ 4 weeks or 5 half-lives prior to Day 1 or is currently enrolled in an investigational study.
17.Has had treatment with etanercept, adalimumab, infliximab, certolizumab, or golimumab (or other TNFi) < 8 weeks prior to Day 1.
18.Has had prior treatment with lymphocyte-depleting therapies, or agents that modulate B- or T-cells.
19.Has received any live or live-attenuated vaccine within 4 weeks prior to Day 1 or plans to receive a live or live-attenuated vaccine during the study and up to 4 weeks or 5 half-lives, whichever is longer, after the last dose of study product.
20.Has had prior treatment with any approved or investigational JAK inhibitors.
21.Has received systemic psoriasis medications other than biologics and/or any systemic immunosuppressants therapy ≤ 4 weeks prior to Day 1.
22.Has received phototherapy ≤ 4 weeks prior to Day 1.
23.Has used topical medications/treatments that could affect psoriasis evaluation ≤ 2 weeks prior to Day 1.
24.Has used shampoos that contain corticosteroids, coal, tar, or vitamin D3 analogs ≤ 2 weeks prior to Day 1.
25.Has used any high potency opioid analgesic at average daily doses of > 30 mg/day of oral morphine or its equivalent or use of variable doses of any opiate analgesic ≤ 6 weeks prior to Day 1.
26.Is pregnant, lactating, or has a positive serum β-hCG measured during Screening.
27.Has had any major surgery ≤ 8 weeks prior to Day 1, or any planned surgery during the study.
28.Has any clinically significant medical condition in the opinion of the investigator, put the participant at undue risk or interfere with interpretation of study results.
29.Has unstable cardiovascular disease, defined as a recent clinical deterioration, or a cardiac hospitalization ≤ 3 months prior to Screening.
30.Has uncontrolled arterial hypertension.
31.Has Class III or IV congestive heart failure by NYHA criteria.
32.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 1 short-term course of oral corticosteroids for asthma ≤ 6 months prior to Day 1.
33.Has a history of cancer or lymphoproliferative disease within 5 years prior to Day 1.
34.Has a known history of clinically significant drug or alcohol abuse in the last year prior to Screening.
35.Has any of the following laboratory values at Screening:
a. ALT or AST values ≥ 2.0 × ULN,
b. Hgb < 9 g/dL,
c. Absolute WBC count < 3.0 × 10^9/L,
d. Absolute neutrophil count < 1.0 × 10^9/L,
e. Absolute lymphocyte count < 0.5 × 10^9/L,
f. PLT count < 100 × 10^9/L,
g. Total bilirubin ≥ 1.5 × ULN,
h. Estimated glomerular filtration rate < 60 mL/min/1.73 m2 by the Chronic Kidney Disease Epidemiology Collaboration equation at Screening,
i. TSH outside the normal range deemed clinically significant by the investigator.
36.Has any other significant laboratory or procedure abnormalities that, in the opinion of the investigator, might place the participant at unacceptable risk for participation in this study.
37.Has history of any significant drug allergy or intolerance or allergy to any component of IMP.
38.Has donated > 50 mL of blood or plasma ≤ 4 weeks of Screening
or > 499 mL of blood or plasma ≤ 8 weeks prior to Screening
or intends to donate blood during the course of study.
E.5 End points
E.5.1Primary end point(s)
-Proportion of participants achieving ACR20 response at Week 16.
-Incidence of TEAEs.
E.5.1.1Timepoint(s) of evaluation of this end point
-Week 16
-Throughout the whole duration of the study
E.5.2Secondary end point(s)
1. Change from baseline in HAQ-DI at Week 16.
2. Proportion of participants achieving PASI75 response at Week 16 in participants with at least 3% BSA involvement at baseline.
3. Change from baseline in SF-36 PCS at Week 16.
4. Proportion of participants achieving ACR50 response at Week 16.
5. Proportion of participants achieving ACR70 response at Week 16.
E.5.2.1Timepoint(s) of evaluation of this end point
Week 16
E.6 and E.7 Scope of the trial
E.6Scope of the trial
E.6.1Diagnosis No
E.6.2Prophylaxis No
E.6.3Therapy Yes
E.6.4Safety Yes
E.6.5Efficacy Yes
E.6.6Pharmacokinetic Yes
E.6.7Pharmacodynamic No
E.6.8Bioequivalence No
E.6.9Dose response Yes
E.6.10Pharmacogenetic No
E.6.11Pharmacogenomic No
E.6.12Pharmacoeconomic No
E.6.13Others No
E.7Trial type and phase
E.7.1Human pharmacology (Phase I) No
E.7.1.1First administration to humans No
E.7.1.2Bioequivalence study No
E.7.1.3Other No
E.7.1.3.1Other trial type description
E.7.2Therapeutic exploratory (Phase II) Yes
E.7.3Therapeutic confirmatory (Phase III) No
E.7.4Therapeutic use (Phase IV) No
E.8 Design of the trial
E.8.1Controlled Yes
E.8.1.1Randomised Yes
E.8.1.2Open No
E.8.1.3Single blind No
E.8.1.4Double blind Yes
E.8.1.5Parallel group Yes
E.8.1.6Cross over No
E.8.1.7Other Yes
E.8.1.7.1Other trial design description
Study consists of a 16-week Treatment Period plus an 36-week LTE Treatment Period
E.8.2 Comparator of controlled trial
E.8.2.1Other medicinal product(s) No
E.8.2.2Placebo Yes
E.8.2.3Other No
E.8.2.4Number of treatment arms in the trial3
E.8.3 The trial involves single site in the Member State concerned No
E.8.4 The trial involves multiple sites in the Member State concerned Yes
E.8.5The trial involves multiple Member States Yes
E.8.5.1Number of sites anticipated in the EEA42
E.8.6 Trial involving sites outside the EEA
E.8.6.1Trial being conducted both within and outside the EEA Yes
E.8.6.2Trial being conducted completely outside of the EEA No
E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
United States
Bulgaria
Czechia
Germany
Hungary
Poland
Spain
E.8.7Trial has a data monitoring committee Yes
E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
LPLV
E.8.9 Initial estimate of the duration of the trial
E.8.9.1In the Member State concerned years2
E.8.9.1In the Member State concerned months1
E.8.9.1In the Member State concerned days
E.8.9.2In all countries concerned by the trial years2
E.8.9.2In all countries concerned by the trial months1
F. Population of Trial Subjects
F.1 Age Range
F.1.1Trial has subjects under 18 No
F.1.1.1In Utero No
F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
F.1.1.3Newborns (0-27 days) No
F.1.1.4Infants and toddlers (28 days-23 months) No
F.1.1.5Children (2-11years) No
F.1.1.6Adolescents (12-17 years) No
F.1.2Adults (18-64 years) Yes
F.1.2.1Number of subjects for this age range: 165
F.1.3Elderly (>=65 years) Yes
F.1.3.1Number of subjects for this age range: 30
F.2 Gender
F.2.1Female Yes
F.2.2Male Yes
F.3 Group of trial subjects
F.3.1Healthy volunteers No
F.3.2Patients Yes
F.3.3Specific vulnerable populations Yes
F.3.3.1Women of childbearing potential not using contraception No
F.3.3.2Women of child-bearing potential using contraception Yes
F.3.3.3Pregnant women No
F.3.3.4Nursing women No
F.3.3.5Emergency situation No
F.3.3.6Subjects incapable of giving consent personally No
F.3.3.7Others No
F.4 Planned number of subjects to be included
F.4.1In the member state28
F.4.2 For a multinational trial
F.4.2.1In the EEA 161
F.4.2.2In the whole clinical trial 195
F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
Standard of Care
G. Investigator Networks to be involved in the Trial
N. Review by the Competent Authority or Ethics Committee in the country concerned
N.Competent Authority Decision Authorised
N.Date of Competent Authority Decision2023-04-26
N.Ethics Committee Opinion of the trial applicationFavourable
N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
N.Date of Ethics Committee Opinion2023-04-05
P. End of Trial
P.End of Trial StatusOngoing
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