Moderate-to-Severe Plaque Psoriasis

To evaluate the dose response of JNJ-77242113 at Week 16 in participants with moderate-to-severe plaque psoriasis

JNJ- 77242113

JNJ- 77242113

tablet

25
50
100

Primary:
Proportion of participants achieving PASI 75 (≥75% improvement from baseline in PASI) at Week 16
Secondary:
Change from baseline in PASI total score at Week 16
Proportion of participants achieving PASI 90 (≥90% improvement from baseline in PASI) at Week 16
Proportion of participants achieving PASI 100 (100% improvement from baseline in PASI) at Week 16
Proportion of participants achieving an IGA score of cleared (0) or minimal (1) at Week 16
Proportion of participants achieving an IGA score of cleared (0) at Week 16
Change from baseline in BSA at Week 16

Age
1. Be ≥18 (or the legal age of consent if it is higher in the jurisdiction in which the study is
taking place) years of age, inclusive.
Type of Participant and Disease Characteristic
2. Criterion modified per Amendment 1
2.1 Has a diagnosis of plaque psoriasis, with or without PsA, for at least 6 months prior
to the first administration of study intervention.
3. Has a total BSA ≥10% at screening and baseline.
4. Has a total PASI ≥12 at screening and baseline.
5. Has a total IGA ≥3 at screening and baseline.
6. Be a candidate for phototherapy or systemic treatment for plaque psoriasis.
7. Must agree to avoid prolonged sun exposure and avoid use of tanning booths or other
ultraviolet (UV) light sources during the study.
8. Otherwise healthy on the basis of physical examination, medical history, and vital signs,
and 12-lead triplicate electrocardiogram (ECG) performed at screening. Any
abnormalities, must be consistent with the underlying illness in the study population and
this determination must be recorded in the participant’s source documents and initialed
by the investigator.
Sex and Contraceptive/Barrier Requirements
9. A woman of childbearing potential must have a negative highly sensitive serum (-human
chorionic gonadotropin [-hCG]) at screening and a negative urine pregnancy test at
Week 0 prior to administration of study intervention.
10. Before randomization, a woman must be either:
a. Not of childbearing potential (Section 10.8).
b. Of childbearing potential and
o Practicing a highly effective method of contraception (failure rate of <1%
per year when used consistently and correctly) prior to receiving study
intervention, during the study, and for at least 12 weeks after receiving the
last administration of study intervention, consistent with local regulations
regarding the use of birth control methods for participants participating in
clinical studies. Examples of highly effective methods of contraception are
located in Section 10.8.
o The investigator should evaluate the potential for contraceptive method
failure (eg, noncompliance, recently initiated) in relationship to the first
dose of study intervention.
Note: If a female participant’s childbearing potential changes after start of the
study (eg, a woman who is not heterosexually active becomes active, a
premenarchal woman experiences menarche), she must begin practicing a highly
effective method of birth control, as described above.
11. A woman must agree not to donate eggs (ova, oocytes) or freeze for future use for the
purposes of assisted reproduction during the study and for at least 12 weeks after receiving
the last administration of study intervention.
12. A male participant who is sexually active with a woman of childbearing potential and
who has not had a vasectomy must agree to use a barrier method of birth control (eg, either
a condom [with spermicidal foam/gel/film/cream/suppository if available in their locale]
or a partner with an occlusive cap [diaphragm or cervical/vault caps] plus spermicidal
foam/gel/film/cream/suppository if available in their locale), during the study and for at
least 12 weeks after receiving the last administration of study intervention. Male
participants should also be advised of the benefit for female partner to use a highly
effective method of contraceptive as condoms may break or leak.
13. A male participant must agree not to donate sperm for the purpose of reproduction during
the study and for at least 12 weeks after receiving the last administration of study
intervention.
Screening Laboratory Test Parameters
14. Have screening laboratory test results within the following parameters. If one or more of
the laboratory parameters is out of range, a single retest of laboratory values is permitted:
a. Hemoglobin ≥10 g/dL (SI: ≥100 g/L)
b. White blood cells ≥3.5 x 103
/μL (SI: ≥3.5 GI/L)
c. Neutrophils ≥1.5 x 103
/μL (SI: ≥1.5 GI/L)
d. Platelets ≥100 x 103
/μL (SI: ≥100 GI/L)
e. Estimated glomerular filtration rate (eGFR) ≥60 mL/min/1.73 m2
f. Aspartate aminotransferase ≤2 × upper limit of normal (ULN)
g. Alanine aminotransferase ≤2 × ULN
h. Alkaline phosphatase ≤2 × ULN
Vaccination
15. Agree not to receive a live virus or live bacterial vaccination during the study, or within
4 weeks after the last administration of study intervention.
General
16. Must sign an informed consent form (ICF) indicating that he or she understands the
purpose of, and procedures required for, the study and is willing to participate in the study.
17. Must sign a separate ICF(s) if he or she agrees to provide optional deoxyribonucleic acid
(DNA) and/or biomarkers samples and/or photographs for research (where local
regulations permit). Refusal to give consent for the optional DNA and/or biomarker
samples and/or photographs does not exclude a participant from participation in the study.
18. Willing and able to adhere to the lifestyle restrictions specified in this protocol.

Disease Characteristics
1. Has a nonplaque form of psoriasis (eg, erythrodermic, guttate, or pustular).
2. Has current drug-induced psoriasis (eg, a new onset of psoriasis or an exacerbation of
psoriasis from beta blockers, calcium channel blockers, or lithium).
Prior/Concomitant Therapy
3. Has previously received any other therapeutic agent directly targeted to IL-23
(including but not limited to guselkumab, tildrakizumab, or risankizumab).
4. Has received any therapeutic agent directly targeted to IL-17 or IL-12/23 (including but
not limited to secukinumab, ixekizumab, brodalumab, or ustekinumab) or has received
anti-TNFα biologic therapy (including, but not limited to adalimumab) within 12 weeks
or 5 half-lives, whichever is longer, of the first administration of study intervention.
5. Criterion modified per Amendment 2
Has received agents that deplete B cells (including, but not limited to, rituximab, or
alemtuzumab) within 26 weeks of the first administration of study intervention.
Has received natalizumab, belimumab, or agents that modulate T cells (including, but
not limited to abatacept or visilizumab) 12 weeks or 5 half-lives, whichever is longer,
of the first administration of study intervention.
7. Has received JAK inhibitor therapy within 4 weeks of the first administration of study
intervention.
8. Has received phosphodiesterase 4 (PDE4) inhibitor therapy (including but not limited
to apremilast) within 4 weeks of the first administration of study intervention.
9. Has received any systemic immunosuppressants (including, but not limited to,
methotrexate [MTX], azathioprine, cyclosporine, 6-thioguanine, mercaptopurine,
mycophenolate mofetil, and tacrolimus) within 4 weeks of the first administration of
study intervention.
10. Has received, or is expected to receive, any live virus or bacterial vaccination within
12 weeks before the first administration of study intervention. For exclusions related to
the bacille Calmette Guerin (BCG)vaccine, see Exclusion 11.
11. Has received the BCG vaccine within 12 months of the first administration of study
intervention.
12. Has received phototherapy or any systemic medications that could affect psoriasis or
the PASI or IGA evaluations (including, but not limited to, oral or injectable
corticosteroids, acitretin, retinoids, 1,25-dihydroxy vitamin D3 and analogues, herbal
treatments or traditional Taiwanese, Korean, or Chinese medicines) within 4 weeks of
the first administration of study intervention.
13. Has received topical therapies that could affect psoriasis or the PASI or IGA evaluation
(including, but not limited to corticosteroids, tar, anthralin, calcipotriene, tazarotene,
methoxsalen, pimecrolimus, tacrolimus, and traditional Taiwanese, Korean, or Chinese
medicines) within 2 weeks of the first administration of study intervention.
Prior/Concurrent Clinical Study Experience
14. Has received an experimental antibody or biologic therapy within 12 weeks or
5 half-lives of the first administration of study intervention or received any other
experimental therapy or new investigational agent within 4 weeks or 5 half-lives
(whichever is longer) of the first study intervention administration or is currently
enrolled in another study using an investigational agent, device, or procedure
Medical Conditions
15. Has a current diagnosis or signs or symptoms of severe, progressive, or uncontrolled
renal, liver, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic,
hematologic, rheumatologic, psychiatric, or metabolic disturbances.
16. Known allergies, hypersensitivity, or intolerance to JNJ-77242113 or its excipients
(refer to the JNJ-77242113 IB).
17. Has had major surgery within 8 weeks before screening, or will not have fully recovered
from surgery, or has surgery planned during the time the participant is expected to
participate in the study.
Note: Participants with planned surgical procedures to be conducted under local
anesthesia may participate.
18. Has a transplanted organ (with exception of a corneal transplant >3 months before the
first administration of study intervention).
19. Has suicidal ideation or suicidal behavior in the last 6 months that may be defined as a
Columbia-Suicide Severity Rating Scale (C-SSRS) rating at screening of: Suicidal
Ideation with Intention to Act (“Ideation level 4”), Suicidal Ideation with Specific Plan
and Intent (“Ideation level 5”), or suicidal behavior (actual suicide attempt, interrupted
suicide attempt, aborted suicide attempt, or preparatory behaviors for making a suicide
attempt), and is considered to be at risk by the investigator based on an evaluation by a
mental health professional. In addition, participants with C-SSRS ratings of Wish to be
Dead (“Ideation level 1”), Non-Specific Active Suicidal Thoughts (“Ideation level 2”),
Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act (“Ideation
level 3”) or non-suicidal self-injurious behavior who are determined to be at risk by the
investigator may not be randomized.
Infections or Predisposition to Infections
20. Has a history of chronic or recurrent infectious disease, including but not limited to
chronic renal infection, chronic chest infection (eg, bronchiectasis), recurrent urinary
tract infection (recurrent pyelonephritis or chronic nonremitting cystitis), fungal
infection (mucocutaneous candidiasis), or open, draining, or infected skin wounds or
ulcers.
21. 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.
22. Has had a serious infection (eg, sepsis, pneumonia, or pyelonephritis), or has been
hospitalized or received IV antibiotics for an infection during the 2 months before
screening.
Has or has had herpes zoster within the 2 months before screening.
24. Has a history of active granulomatous infection, including histoplasmosis or
coccidioidomycosis, before screening. Refer to Exclusion Criterion 32 for information
regarding eligibility with a history of latent TB.
25. Has a chest radiograph within 3 months before the first administration of study
intervention that shows an abnormality suggestive of a malignancy or current active
infection, including TB.
26. Has ever had a nontuberculous mycobacterial infection or opportunistic infection (eg,
cytomegalovirus, pneumocystis, or aspergillosis).
27. Tests positive for hepatitis B virus (HBV) infection (Section 10.10) or who are
seropositive for antibodies to hepatitis C virus (HCV) at screening.
28. Has a history of human immunodeficiency virus (HIV) antibody positive or tests
positive for HIV at screening.
29. Criteria modified per Amendment 2.
29.1 COVID-19 Infection:
During the 6 weeks prior to baseline, have had ANY of the following (regardless of
vaccination status): (a) confirmed severe acute respiratory syndrome coronavirus 2
(SARS-CoV-2) infection (test positive) OR (b) suspected SARS-CoV-2 infection
(clinical features of COVID-19 without documented test results), OR (c) close contact
with a person with known or suspected SARS-CoV-2 infection:
 Exception: may be included with a documented negative result for a validated
SARS-CoV-2 test:
(i) obtained at least 2 weeks after conditions (a), (b), (c) above (timed from
resolution of key clinical features if present, [eg, fever, cough, or dyspnea])
AND
(ii) with absence of ALL conditions (a), (b), (c) above during the period between the
negative test result and the baseline study visit.
NOTE on COVID-related exclusion:
 The field of COVID-related testing (for presence of, and immunity to, the
SARS-CoV-2 virus) is rapidly evolving. Additional testing may be performed as
part of screening and/or during the study if deemed necessary by the investigator
and in accordance with current regulations/guidance from authorities/standards of
care.
Precaution: for those who may carry a higher risk for severe COVID-19 illness, follow
guidance from local health authorities when weighing the potential benefits and risks
of enrolling in the study, and during participation in the study.
Malignancy or Increased Potential for Malignancy
30. Currently has a malignancy or has a history of malignancy within 5 years before
screening (with the exception of a non-melanoma skin cancer that has been adequately
treated with no evidence of recurrence for at least 3 months before the first study
intervention administration or cervical carcinoma in situ that has been treated with no
evidence of recurrence for at least 3 months before the first study intervention
administration).
31. Has a history of lymphoproliferative disease, including lymphoma; a history of
monoclonal gammopathy of undetermined significance; or signs and symptoms
suggestive of possible lymphoproliferative disease, such as splenomegaly or significant
lymphadenopathy.
Tuberculosis
32. Meet ANYof the following tuberculosis (TB) screening criteria.
Note: Interferon gamma release assay (IGRA) testing includes either
QuantiFERON-TB® or T-SPOT®TB.
a. Have a history of active TB or show signs or symptoms suggestive of active
TB upon medical history and/or physical examination at screening.
b. Have a history of untreated latent TB prior to screening. An exception is made
for participants who are currently receiving treatment or will initiate treatment
for latent TB prior to first administration of study intervention.
Note: For participants with a history of treated latent TB there must be
documentation of appropriate treatment prior to the first administration of
study intervention. It is the responsibility of the investigator to verify the
adequacy of previous TB treatment and provide appropriate documentation.
IGRA testing is not required at screening for participants with a history of
treated latent TB or ongoing treatment for latent TB.
c. Have had recent close contact with a person with active TB. An exception is
made if such participants are referred to a physician specializing in TB to
determine if treatment is warranted or not. This evaluation must be adequately
documented and, if treatment is recommended, the participant must be
receiving appropriate treatment prior to the first administration of study
intervention.
d. Have a positive IGRA test result within 2 months prior to the first
administration of study intervention. An exception is made for participants
who:
- have a history of adequately treated latent TB described above.
- have a newly identified positive IGRA test result in which active TB has
been ruled out and for which appropriate treatment for latent TB has been
initiated prior to the first administration of study intervention.
- have a false-positive IGRA test as determined by the following:
o A suspected false-positive initial IGRA test must be repeated. If
repeat testing is NOT positive, the participant must be referred to a
physician specializing in TB to determine if the initial test can be
considered a false-positive. This evaluation must be adequately
documented prior to the first administration of study intervention.
If repeat testing is positive, however, it will be considered a truepositive and the participant is only eligible if active TB has been
ruled out and appropriate treatment for latent TB has been initiated
as described above.
Note: Indeterminate/borderline results should be handled as outlined in
Section 8.2.8.
e. Have a chest radiograph or chest computed tomography within 3 months prior
to the first administration of study intervention that shows abnormalities
suggestive of active or inactive TB.
Other Exclusions
33. Is an employee of the investigator or study site, with direct involvement in the proposed
study or other studies under the direction of that investigator or study site, as well as
family members of the employees or the investigator.
34. Is pregnant, nursing, or planning a pregnancy (both men and women) while enrolled in
the study or within 12 weeks following the last dose of study intervention.
35. Has a history of drug or alcohol abuse according to Diagnostic and Statistical Manual
of Mental Disorders (5th edition) criteria within 12 months before screening.
36. Has any condition for which, in the opinion of the investigator, participation would not
be in the best interest of the participant (eg, compromise the well-being) or that could
prevent, limit, or confound the protocol-specified assessments.