A Study of Zasocitinib in Adults with Psoriatic Arthritis Who Have Not Taken Biologic Medicines
- Conditions
- Psoriatic Arthritis
- Interventions
- Registration Number
- 2024-513111-27-00
- Lead Sponsor
- Takeda Development Center Americas Inc.
- Brief Summary
To evaluate the efficacy of zasocitinib (Dose A or Dose B) compared with placebo in subjects with active psoriatic arthritis (PsA).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised, recruitment pending
- Sex
- Not specified
- Target Recruitment
- 652
The subject is willing and able to understand and fully comply with study procedures and requirements in the opinion of the investigator.
If the subject is receiving other concurrent treatments, they must be at the following stable doses: oral corticosteroids (≤10 mg/day of prednisone equivalent), NSAIDs or paracetamol/acetaminophen or low-potency opiates (only tramadol up to 300 mg/day or combination of acetaminophen and codeine or hydrocodone are permitted) at stable dose for ≥1 week prior to the Day 1 visit. Initiation of these treatments between screening and Day 1 is not permitted.
The subject meets the following birth control requirements: a) An individual with potential for pregnancy, who is now surgically sterile; OR b) A subject of nonchildbearing potential with laboratory confirmation of postmenopausal status OR c) If sexually active with a nonsterilized individual who produces sperm, an individual with potential for pregnancy who agrees to use a highly effective method of contraception from the signing of the ICF throughout the duration of the study and for 10 days after the last dose of the trial intervention. The use of effective contraception is not required for subjects assigned male sex at birth during the duration of the study. Note: Oral hormonal contraception may be susceptible to interaction with zasocitinib, which may reduce the efficacy of the contraceptive method. Therefore, if subject is on a form of oral contraception, a second highly effective or effective method of contraception should be used during the entire study and for at least 10 days after the last dose of trial intervention. A barrier method is recommended, preferably a male external condom. Of note, an effective contraception method is only permitted in the case that hormonal contraception is used as the primary highly effective method of contraception.
For subjects aged 65 years or older, the investigator must perform a benefit-risk assessment to justify the subject’s inclusion in the study.
For subjects currently smoking/chewing tobacco or with a history of long-term smoking (≥20 pack years)/chewing tobacco use, the investigator must perform a benefit-risk assessment to justify the subject’s inclusion in the study.
For subjects who elect to use hormonal contraception as a form of highly effective contraception, the investigator must perform a benefit-risk assessment to justify the subject’s inclusion in the study at screening.
The subject has provided informed consent (that is, in writing, documented via a signed and dated ICF) and any required privacy authorization before the initiation of any study procedures.
The subject is aged 18 years or older at the time of signing the ICF. In South Korea, the age requirement for adult subjects is ≥19 years of age.
The subject has had signs and symptoms consistent with PsA for at least 3 months.
The subject meets the CASPAR criteria.
The subject has active arthritis as shown by a minimum of ≥3 tender joints in TJC68 and ≥3 swollen joints in SJC66 at the screening and baseline (Day 1) visits.
The subject has at least 1 active lesion of plaque PsO ≥2 cm in diameter, or any nail or nail bed changes characteristic of PsO.
The subject has had at least one of the following: The subject has had inadequate response to a csDMARD after a minimum of 12 consecutive weeks of therapy (at the maximally tolerated dose or up to dose defined in Inclusion Criterion 9), or intolerance to a csDMARD (defined as treatment-related AEs).
If the subject is on concomitant csDMARDs at study entry, the subject must be on ≤2 csDMARDs for ≥12 weeks. The doses must be stable for ≥4 weeks prior to the Day 1 visit as follows: MTX (≤25 mg/week; ≤16 mg/week for Japan sites only), SSZ (≤3000 mg/day), LEF (≤20 mg/day), and HCQ (≤400 mg/day). The combination of MTX and LEF is not allowed. a) Subjects who need to discontinue DMARDs prior to the Day 1 visit to comply with this inclusion criterion must follow the procedure specified below or at least 5 times the mean terminal elimination half-life of a drug: • ≥8 weeks for LEF if no elimination procedure was followed, or adhere to an elimination procedure (ie, 11 days with cholestyramine, or 30 days washout with activated charcoal or per local label); • ≥4 weeks for all others.
The subject has other disease(s) that might confound the evaluations of benefit of zasocitinib therapy, including but not limited to rheumatoid arthritis, axial spondyloarthritis (this does not include a primary diagnosis of PsA with spondylitis), systemic lupus erythematosus, Lyme disease, gout, or fibromyalgia (prior history of reactive arthritis or axial spondyloarthritis, including ankylosing spondylitis and nonradiographic axial spondyloarthritis, is permitted if there is documentation of change in diagnosis to PsA or additional diagnosis of PsA is made. Prior history of fibromyalgia is permitted if there is documentation of change in diagnosis to PsA or documentation that the diagnosis of fibromyalgia was made incorrectly).
The subject has received phototherapy (including UV B, psoralen and UV A, tanning beds, therapeutic sunbathing) or excimer laser within 4 weeks prior to Day 1.
The subject has used botanical preparations (eg, herbal or homeopathic supplements or traditional medicines, including traditional Chinese medicines derived from plants, minerals, or animals) intended to treat PsA, PsO, or other immunological diseases within 4 weeks prior to Day 1.
The subject has a history of active infection or febrile illness with or without symptoms (including but not limited to coryza and pharyngitis) within 10 days prior to Day 1, as assessed by the investigator.
Tuberculosis (TB): a) The subject has a history of active TB infection, regardless of treatment status. b) The subject has signs or symptoms of active TB (including but not limited to chronic fever, chronic productive cough, night sweats, or weight loss) as judged by the investigator. c) The subject has evidence of a latent TB infection as evidenced by a positive QFT-TB Gold result OR 2 indeterminate QFT IGRA results. The subject may remain eligible if: (1) there are no signs/symptoms of active TB and documentation of no prior history of active TB can be provided and (2) subject can provide documentation of prior completed treatment for LTBI (appropriate in duration and type per current local country guidelines) OR is willing to initiate LTBI prophylaxis (appropriate in duration and type per current local guidelines) a minimum of 2 weeks prior to Day 1. In the EU/EEA participants with evidence of LTBI, regardless of prophylaxis treatment status, must receive approval to participate in the trial from an infectious disease or other TB specialist (for example, pulmonologist). Note: TB prophylaxis regimens should be administered according to local guidelines; however, because of potential interactions with zasocitinib and active comparator, rifampin should not be used. TB testing should be conducted using QFT submitted to the central laboratory unless alternate or additional tests are required per local guidelines. d) The subject has had any imaging study during or 6 months prior to screening, including x-ray, chest CT, MRI, or other chest imaging suggesting evidence of current active or a history of active TB. X-ray is required for all subjects regardless of QFT results unless the subject has had normal chest imaging in the 6 months prior to screening.
Herpes infections: a) The subject has active herpes virus infection, including herpes zoster or herpes simplex 1 and 2 (demonstrated on physical examination and/or medical history), at screening or Day 1. b) The subject has a history of serious herpetic infection that includes any episode of disseminated disease, multidermatomal herpes zoster, herpes encephalitis, ophthalmic herpes, or recurrent herpes zoster (defined as 2 episodes within 2 years).
Nonherpetic viral diseases: a) The subject has presence of HCV antibody and a positive confirmatory test result forHCV RNA (nucleic acid test or polymerase chain reaction). b) The subject has presence of positive hepatitis B virus surface antigen (HBsAg+), indeterminate hepatitis B surface antigen, or positive anti-hepatitis B core antibody (HBcAb+). Subjects with positive anti-hepatitis B surface antibody (HBsAb+) may enroll if there is medical record documentation of HBV vaccination. For subjects without a documented history of HBV vaccination, a positive hepatitis B surface antibody (HBsAb+) is exclusionary. c) The subject has a history of positive results for HIV by serology, regardless of viral load. d) Additional monitoring guidelines for nonherpetic viral disease may be applicable per local guidelines.
Other infectious diseases: a) The subject has a history of symptoms suggestive of systemic or invasive infection within 30 days prior to Day 1. b) The subject has history of bacterial, viral, or fungal infection that required hospitalization or treatment with intravenous antimicrobial therapy within 8 weeks prior to Day 1 or oral antimicrobial therapy within 30 days prior to Day 1. c) The subject has a history of chronic or recurrent bacterial disease, including but not limited to chronic pyelonephritis or cystitis, chronic bronchitis/pneumonitis, osteomyelitis, or chronic skin ulcerations/infections or fungal infections (except superficial onychomycosis). d) The subject has a history of an infected joint prosthesis or has received antibiotics for a suspected infection of a joint prosthesis, unless that prosthesis has been removed or replaced at least 60 days prior to Day 1. e) The subject has a history of opportunistic infections (eg, Pneumocystis jirovecii pneumonia, histoplasmosis, coccidiomycosis). f) The subject had a bacterial infection within 60 days prior to Day 1 for which they did not receive treatment.
The subject has any clinically significant medical condition, evidence of an unstable clinical condition (eg, cardiovascular, renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, or immunologic), 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. These include but are not limited to: a) The subject has a history of known or suspected condition/illness that is consistent with compromised immunity, including but not limited to any identified congenital or acquired immunodeficiency; splenectomy. b) The subject had a major surgery within 60 days prior to Day 1 or has a major surgery planned during the study. c) The subject has moderate or severe hepatic impairment per Child-Pugh classification (Class B and C). d) The subject has uncontrolled hypertension characterized by systolic blood pressure >160 mm Hg or diastolic blood pressure >100 mm Hg at screening, confirmed by 2 repeat assessments. e) The subject has a history of Class III or IV congestive heart failure as defined by New York Heart Association criteria. f) The subject has a history of cancer or lymphoproliferative disease, with the exception of successfully treated nonmetastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix, under the condition that the investigator performs a benefit-risk assessment. g) For subjects with asthma, chronic obstructive pulmonary disease, or other pulmonary illnesses, the subject has been hospitalized in the past 3 months, has ever required intubation for treatment, currently requires oral corticosteroids treatment, or has required more than 1 course of oral corticosteroids within 6 months prior to Day 1. h) The subject has any of the following cardiovascular disease history: • A new diagnosis of atrial fibrillation or an episode of atrial fibrillation with rapid ventricular response or other dysrhythmia, non-acute cardiac hospitalization (eg, pacemaker implantation), pulmonary embolism, or deep venous thrombosis within the past 6 months prior to screening. • Cerebrovascular event, myocardial infarction, coronary stenting, or aorto-coronary bypass surgery within the last 6 months. A subject may enroll if it has been at least 6 months since the occurrence of any such event and the subject is considered clinically stable by the investigator; in the EU/EEA, the investigators should perform a benefit-risk assessment. i) The subject has ECG abnormalities that are considered clinically significant and would pose an unacceptable risk to the subject if they participated in the study, in the opinion of the investigator. j) The subject has a lifetime history of any significant/uncontrolled psychiatric illness (including but not limited to active suicidal ideation at screening or Day 1 by answering “yes” to Questions 4 or 5 for suicidal ideation or any suicidal behavior on the C-SSRS) for which participation in the trial would, in the opinion of the investigator, put the subject at undue risk, or would interfere with interpretation of study results. k) Per medical judgement, the subject has a known history of clinically significant drug or alcohol abuse, excluding stable medical or legal recreational marijuana/tetrahydrocannabinol/cannabidiol use, within 12 months of the screening visit.
The subject has received lithium or intramuscular gold therapy within 4 weeks prior to Day 1.
The subject is currently being treated with strong or moderate CYP3A4 inhibitors (such as itraconazole or clarithromycin) or strong or moderate CYP3A4 inducers (such as rifampin, carbamazepine, or phenytoin), or has received strong or moderate CYP3A4 inhibitors or strong or moderate CYP3A4 inducers within 4 weeks or 5 half-lives of the inducer or inhibitor, whichever is longer, prior to Day 1, or is expected to require treatment with strong or moderate CYP3A4 inducers or inhibitors during the trial period. Note: This includes consumption of food or beverages containing grapefruit and/or Seville oranges within 1 week of Day 1. Subjects must be counseled to avoid food or beverages containing grapefruit and/or Seville oranges for the duration of the study.
The subject has a history of excessive sun exposure has used tanning booths within 4 weeks prior to Day 1, or is not willing to minimize natural and artificial sunlight exposure during the study period. Use of sunscreen products and protective apparel is recommended when sun exposure cannot be avoided.
The subject has received any live-attenuated vaccine within 60 days prior to Day 1 or plans to receive a live-attenuated vaccine during the study and up to 4 weeks after the last trial intervention administration. Note: Non–live-attenuated vaccines or boosters for COVID-19 (eg, RNA-based vaccines, inactivated adenovirus-based vaccines, influenza vaccines, protein-based vaccines) are permitted during the study. The study site should follow local COVID-19 guidelines.
The subject received a marketed or investigational biological agent (other than those for the treatment of PsA or PsO) within 12 weeks or 5 half-lives, whichever is longer, prior to Day 1
The subject is currently receiving a nonbiological investigational product or device or has received one within 4 weeks or 5 half-lives, whichever is longer, prior to Day 1.
The subject is currently enrolled in a clinical trial or anticipates enrollment in a clinical trial during the course of the study.
The subject has any of the following laboratory values at the screening visit: a) AST or ALT values ˃3 × ULN. b) TBili (unconjugated and/or conjugated) ˃1.5 × ULN. c) Hemoglobin <9.0 g/dL (<90.0 g/L). d) Absolute white blood cell count <3.0 × 109/L (<3000/mm3). e) Absolute neutrophil count of <1.0 × 109/L (<1000/mm3). f) Absolute lymphocyte count of <0.5 × 109/L (<500/mm3). g) Platelet count <100 × 109/L (<100,000/mm3). h) Estimated creatinine clearance <45 mL/min based on the Cockcroft-Gault calculation. i) CPK > ULN. CPK may be repeated once; if repeat value is CTCAE Grade 1 or lower (≤2.5 × ULN) and no higher than the initial value, subject remains eligible. Investigators should assess the subject for modulating factors, including concomitant medications or vigorous exercise, that may affect CPK level. j) The subject has any other significant laboratory abnormalities that, in the opinion of the investigator, might place the subject at unacceptable risk for participation in this study.
The subject does not tolerate venipuncture or inability to be venipunctured.
The subject has a history of significant drug allergy (such as anaphylaxis).
The subject has contraindications listed in the country-specific label for apremilast (such as presence of rare hereditary problems of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption).
The subject has a known or suspected allergy to zasocitinib, apremilast, or any of their components
The subject has a positive pregnancy test result or plans to become pregnant during the study period, or subject is pregnant or lactating/nursing.
The subject has a concomitant comorbid skin condition that, in the opinion of the investigator, would interfere with the study assessments, such as evidence of non–plaque PsO (erythrodermic, pustular, predominately guttate PsO, inverse, or drug-induced PsO).
The subject has given greater than 500 mL of blood or plasma within 30 days of screening (during a clinical trial or at a blood bank donation) or plans to donate blood during the course of the study.
The subject is compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness or is committed to an institution (eg, prison) by virtue of an order issued either by judicial or administrative authorities.
The subject is a study site employee, an immediate family member (eg, spouse, parent, child, sibling), or is in a dependent relationship with study site employee who is involved in the conduct of the study or may consent under duress.
The subject has received any of the following treatments: a) A biologic that is used for treatment of PsA or PsO (eg, TNFi [eg, etanercept, adalimumab, infliximab, certolizumab pegol, golimumab]; IL-12/23, IL-17, or IL-23 inhibitors [eg, ustekinumab, secukinumab, bimekizumab, brodalumab, ixekizumab, guselkumab, tildrakizumab, or risankizumab]). b) Any TYK2 inhibitor (eg, deucravacitinib, VTX958, or GLPG3367) or oral JAK inhibitor (eg, upadacitinib, baricitinib, or tofacitinib). c) Rituximab or other immune cell-depleting agents within 6 months prior to Day 1. d) Agents that modulate integrin pathways to impact lymphocyte trafficking (eg, natalizumab) or agents that modulate B cells or T cells (eg, alemtuzumab, visilizumab, or abatacept) within 3 months prior to Day 1.
The subject is receiving current treatment with >2 csDMARDs or use of csDMARDs other than MTX, SSZ, LEF, and HCQ or use of MTX in combination with LEF.
The subject has had prior or current treatment with active comparator.
The subject has used medicated shampoo and/or body wash that includes but is not limited to salicylic acid, corticosteroids, coal tar, or vitamin D3 analogues within 2 weeks prior to Day 1.
The subject has used any topical medication that could affect PsA or PsO presentation, including but not limited to: corticosteroids, salicylic acid, roflumilast, urea, alpha- or betahydroxy acids, anthralin, retinoids, vitamin D analogues (such as calcipotriol), tazarotene, methoxsalen, trimethylpsoralen, pimecrolimus, tacrolimus, tapinarof, or tar within 2 weeks prior to Day 1; with the exception of low-potency topical steroids (WHO Class VI and VII) on the palms, soles, face, intertriginous areas, and/or genitals and/or bland emollients on all body regions
The subject has used any other nonbiologic treatment that could affect PsA or PsO presentation (including oral, intravenous, intramuscular, intra-articular, intrathecal, epidural, or intralesional corticosteroids; oral retinoids; immunosuppressive/immunomodulating medication; 6-thioguanidine; mercaptopurine; mycophenolate mofetil; hydroxyurea; cyclosporine; roflumilast; 1,25-dihydroxyvitamin D3 analogues; psoralens; fumaric acid derivatives) within 4 weeks prior to Day 1, or 5 half-lives, whichever is longer. Note: Intranasal corticosteroids, inhaled corticosteroids, and eye and ear drops containing corticosteroids are permitted.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Zasocitinib Dose B Zasocitinib Participants will receive zasocitinib Dose B, tablets, orally, QD for up to Week 52. Placebo + Zasoctinib Zasocitinib Participants will receive placebo, orally, QD for up to Week 16, followed by zasoctinib Dose A or Dose B, orally, QD, from Week 16 up to Week 52. Zasocitinib Dose A Zasocitinib Participants will receive zasocitinib Dose A, tablets, orally, once daily (QD) for up to Week 52. Active Comparator Dose C Active Comparator Participants will receive active comparator Dose C, capsules, orally, twice daily (BID) for up to Week 52. Placebo + Zasoctinib Placebo Participants will receive placebo, orally, QD for up to Week 16, followed by zasoctinib Dose A or Dose B, orally, QD, from Week 16 up to Week 52.
- Primary Outcome Measures
Name Time Method ACR20 response: Assessed as proportion of subjects achieving ACR20 at Week 16. ACR20 response: Assessed as proportion of subjects achieving ACR20 at Week 16.
- Secondary Outcome Measures
Name Time Method 1. Key Secondary endpoint : Zasocitinib Dose A vs. Placebo • MDA: Assessed as proportion of subjects achieving MDA status at Week 16. • PASI75 response (in subjects with a baseline ≥3% BSA): Assessed as proportion of subjects achieving ≥75% improvement from baseline in PASI score at Week 16. 1. Key Secondary endpoint : Zasocitinib Dose A vs. Placebo • MDA: Assessed as proportion of subjects achieving MDA status at Week 16. • PASI75 response (in subjects with a baseline ≥3% BSA): Assessed as proportion of subjects achieving ≥75% improvement from baseline in PASI score at Week 16.
2. Key Secondary endpoint: ACR50 response: Assessed as proportion of subjects achieving ACR50 at Week 16. • Change from baseline in the HAQ-DI score at Week 16. • ACR70 response: Assessed as proportion of subjects achieving ACR70 at Week 16. 2. Key Secondary endpoint: ACR50 response: Assessed as proportion of subjects achieving ACR50 at Week 16. • Change from baseline in the HAQ-DI score at Week 16. • ACR70 response: Assessed as proportion of subjects achieving ACR70 at Week 16.
3. Key Secondary endpoint: Change from baseline in the SF-36 v2.0 PCS score at Week 16. • Change from baseline in the FACIT-Fatigue score at Week 16. 3. Key Secondary endpoint: Change from baseline in the SF-36 v2.0 PCS score at Week 16. • Change from baseline in the FACIT-Fatigue score at Week 16.
4. Key Secondary endpoint: Zasocitinib Dose B vs. Placebo • MDA: Assessed as proportion of subjects achieving MDA status at Week 16. • ACR50 response: Assessed as proportion of subjects achieving ACR50 at Week 16. 4. Key Secondary endpoint: Zasocitinib Dose B vs. Placebo • MDA: Assessed as proportion of subjects achieving MDA status at Week 16. • ACR50 response: Assessed as proportion of subjects achieving ACR50 at Week 16.
5. Key Secondary endpoint: Change from baseline in the HAQ-DI score at Week 16. • ACR70 response: Assessed as proportion of subjects achieving ACR70 at Week 16. 5. Key Secondary endpoint: Change from baseline in the HAQ-DI score at Week 16. • ACR70 response: Assessed as proportion of subjects achieving ACR70 at Week 16.
6. Key Secondary endpoint: PASI75 response (in subjects with a baseline ≥3% BSA): Assessed as proportion of subjects achieving ≥75% improvement from baseline in PASI score at Week 16. 6. Key Secondary endpoint: PASI75 response (in subjects with a baseline ≥3% BSA): Assessed as proportion of subjects achieving ≥75% improvement from baseline in PASI score at Week 16.
7. Key Secondary endpoint: Zasocitinib Dose A vs. active comparator • ACR20 response: Assessed as proportion of subjects achieving ACR20 at Week 16. • PASI75 response (in subjects with a baseline ≥3% BSA): Assessed as proportion of subjects achieving ≥75% improvement from baseline in PASI score at Week 16. 7. Key Secondary endpoint: Zasocitinib Dose A vs. active comparator • ACR20 response: Assessed as proportion of subjects achieving ACR20 at Week 16. • PASI75 response (in subjects with a baseline ≥3% BSA): Assessed as proportion of subjects achieving ≥75% improvement from baseline in PASI score at Week 16.
8. Key Secondary endpoint: Zasocitinib Dose B vs. active comparator • ACR20 response: Assessed as proportion of subjects achieving ACR20 at Week 16. 8. Key Secondary endpoint: Zasocitinib Dose B vs. active comparator • ACR20 response: Assessed as proportion of subjects achieving ACR20 at Week 16.
1. Zasocitinib Dose A vs. Placebo Zasocitinib Dose B vs. Placebo • Enthesitis resolution in subjects with enthesitis at baseline (LEI >0): Assessed as proportion of subjects meeting LEI=0 at Week 16. • Change from baseline in individual components of ACR response at Week 16. 1. Zasocitinib Dose A vs. Placebo Zasocitinib Dose B vs. Placebo • Enthesitis resolution in subjects with enthesitis at baseline (LEI >0): Assessed as proportion of subjects meeting LEI=0 at Week 16. • Change from baseline in individual components of ACR response at Week 16.
2. Dactylitis resolution in subjects with dactylitis (LDI Basic >0) at baseline: Assessed as proportion of subjects meeting LDI Basic=0 at Week 16. • PASI75 response (in subjects with ≥3% BSA at baseline) at Week 8. 2. Dactylitis resolution in subjects with dactylitis (LDI Basic >0) at baseline: Assessed as proportion of subjects meeting LDI Basic=0 at Week 16. • PASI75 response (in subjects with ≥3% BSA at baseline) at Week 8.
3. PASI90 response (in subjects with ≥3% BSA at baseline) at Week 16. • PASI100 response (in subjects with ≥3% BSA at baseline) at Week 16. 3. PASI90 response (in subjects with ≥3% BSA at baseline) at Week 16. • PASI100 response (in subjects with ≥3% BSA at baseline) at Week 16.
4. ACR50 and PASI100 response (in subjects with ≥3% BSA at baseline): Assessed as proportion of subjects simultaneously achieving ACR50 and PASI100 at Week 16. 4. ACR50 and PASI100 response (in subjects with ≥3% BSA at baseline): Assessed as proportion of subjects simultaneously achieving ACR50 and PASI100 at Week 16.
5. sPGA 0/1 response (in subjects with baseline sPGA ≥2): Assessed as proportion of subjects achieving an sPGA of clear (0) or almost clear (1) with a ≥2-point decrease from baseline at Week 16. 5. sPGA 0/1 response (in subjects with baseline sPGA ≥2): Assessed as proportion of subjects achieving an sPGA of clear (0) or almost clear (1) with a ≥2-point decrease from baseline at Week 16.
6. HAQ-DI response: Assessed as proportion of HAQ-DI minimal clinically important differences responders (defined as achieving a clinically meaningful reduction of ≥0.35 from baseline) at Week 16. • Change from baseline in the SF-36 v2.0 MCS score at Week 16. 6. HAQ-DI response: Assessed as proportion of HAQ-DI minimal clinically important differences responders (defined as achieving a clinically meaningful reduction of ≥0.35 from baseline) at Week 16. • Change from baseline in the SF-36 v2.0 MCS score at Week 16.
7. Change from baseline in PsAID-12 total score at Week 16. • Change from baseline in DAPSA score at Week 16. 7. Change from baseline in PsAID-12 total score at Week 16. • Change from baseline in DAPSA score at Week 16.
8. Change from baseline in DAS28[CRP] score at Week 16. • Change from baseline in PGA-F score in subjects with psoriatic nail involvement (PGA-F>0) at baseline at Week 16. 8. Change from baseline in DAS28[CRP] score at Week 16. • Change from baseline in PGA-F score in subjects with psoriatic nail involvement (PGA-F>0) at baseline at Week 16.
9. Zasocitinib Dose B vs. Placebo • Change from baseline in the SF-36 v2.0 PCS score at Week 16. • Change from baseline in the FACIT-Fatigue score at Week 16. 9. Zasocitinib Dose B vs. Placebo • Change from baseline in the SF-36 v2.0 PCS score at Week 16. • Change from baseline in the FACIT-Fatigue score at Week 16.
10. Zasocitinib Dose A vs. active comparator Zasocitinib Dose B vs. active comparator • ACR50 response: Assessed as proportion of subjects achieving ACR50 at Week 16. • ACR70 response: Assessed as proportion of subjects achieving ACR70 at Week 16. 10. Zasocitinib Dose A vs. active comparator Zasocitinib Dose B vs. active comparator • ACR50 response: Assessed as proportion of subjects achieving ACR50 at Week 16. • ACR70 response: Assessed as proportion of subjects achieving ACR70 at Week 16.
11. PASI90 response (in subjects with ≥3% BSA at baseline) at Week 16. • PASI100 response (in subjects with ≥3% BSA at baseline) at Week 16. 11. PASI90 response (in subjects with ≥3% BSA at baseline) at Week 16. • PASI100 response (in subjects with ≥3% BSA at baseline) at Week 16.
12. ACR50 and PASI100 response (in subjects with ≥3% BSA at baseline): Assessed as proportion of subjects simultaneously achieving ACR50 and PASI100 at Week 16. • MDA: Assessed as proportion of subjects achieving MDA status at Week 16. 12. ACR50 and PASI100 response (in subjects with ≥3% BSA at baseline): Assessed as proportion of subjects simultaneously achieving ACR50 and PASI100 at Week 16. • MDA: Assessed as proportion of subjects achieving MDA status at Week 16.
Trial Locations
- Locations (96)
Complex Rendelo Med Zrt.
🇭🇺Szekesfehervar, Hungary
Vital-Medicina Kft.
🇭🇺Veszprem, Hungary
Fejer Varmegyei Szent Gyoergy Egyetemi Oktato Korhaz
🇭🇺Szekesfehervar, Hungary
Qualiclinic Kft.
🇭🇺Budapest, Hungary
University Of Szeged
🇭🇺Szeged, Hungary
Vasarhelyi Sarkanyfu Kft.
🇭🇺Hodmezovasarhely, Hungary
Parc Tauli Hospital Universitari
🇪🇸Sabadell, Spain
Hospital Universitario De Badajoz
🇪🇸Badajoz, Spain
Hospital Universitario Virgen De La Macarena
🇪🇸Sevilla, Spain
Complexo Hospitalario Universitario De Santiago
🇪🇸Santiago De Compostela, Spain
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