Moderate to Severe Atopic Dermatitis
Conditions
Interventions
Group 4:Placebo (weeks 0 to 12), then converted to JNJ-95597528 900 mg in week 12, and given 450 mg subcutaneously in week 24
Group 2:JNJ-95597528 900 mg (Week 0), followed by 450 mg by subcutaneous injection in weeks 12 and 24
Group 1:JNJ-95597528 1050 mg, subcutaneous injection. Administration time points: Week 0, week 2, week 12 and week 24
Group 3:JNJ-95597528 300 mg (Week 0), followed by 150 mg subcutaneous injection in weeks 12 and 24
Sponsors
China-Japan Friendship Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. >=18 years of age (or at least the legal age of consent in the jurisdiction in which the study is taking place) at the time of informed consent. 2. Be otherwise healthy on the basis of physical examination, medical history, vital signs, and 12-lead 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. 3. Meets all the following disease activity: (1) Chronic AD, according to American Academy of Dermatology Consensus Criteria (Eichenfield 2014) with onset of symptoms at least 1 year prior to screening visit, as determined by the investigator through participant interview and/or review of the medical history. (2) EASI score >=16 at the Screening and Week 0; (3) vIGA-AD score >=3 at the Screening and Week 0; (4) >=10% BSA of AD involvement at the Screening and Week 0; (5) Documented history (within 6 months before screening) of either inadequate response or inadvisability to medicated topical treatments for AD or inadequate response to systemic therapies (within 12 months before screening). 4. A female participant, while enrolled in this study and within 12 months (approximately 355 days) after the last dose of study intervention, must: (1) Not be pregnant, breastfeeding, or plan to become pregnant. (2) Agree to not donate gametes (ie, eggs) or freeze for future use for the purposes of assisted reproduction. (3) Either: 1) Not be of childbearing potential OR 2) Is of childbearing potential and: Has a negative highly sensitive (eg, ß-hCG) pregnancy test at screening and a negative urine pregnancy test at Week 0 prior to administration of study intervention and agrees to further pregnancy tests. Practices at least 1 highly effective method of contraception. The investigator must evaluate the potential for contraceptive method failure (eg, noncompliance, recently initiated) in relationship to the first dose of study intervention. The method selected must meet local/regional regulations/guidelines. Note: If a participant’s childbearing potential changes after start of the study (eg, a premenarchal female participant experiences menarche) or the risk of pregnancy changes (eg, a female participant who is not heterosexually active becomes active, or method of contraception changes), a female participant must begin using a highly effective method of contraception. The investigator is responsible for reviewing medical history, menstrual history, and recent sexual activity to reduce the risk of inclusion of women with an early undetected pregnancy. A male participant, while enrolled in this study and for at least 12 months (approximately 355 days) after the last dose of study intervention, must: (1) Agree not to father a child (2) Agree not to donate sperm or freeze for future use for the purposes of assisted reproduction. (3) Have had a vasectomy OR (4) A male participant who has not had a vasectomy must agree to use a barrier method of birth control (eg, either wear 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) when engaging in any activity that allows for passage of ejaculate to a female of childbearing potential. Male participants must also be advised of the benefit for a female
Exclusion criteria
Exclusion criteria: 1. Currently have active skin disease other than AD (eg, psoriasis) or has any ongoing significant skin condition including skin infections (eg, eczema herpeticum, molluscum contagiosum, impetigo), that, according to the investigator, could interfere with efficacy assessments. Note: Concomitant keratosis pilaris or ichthyosis vulgaris associated with AD may not need to be exclusionary; 2. Current diagnosis or signs or symptoms of severe, progressive, or uncontrolled renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances. 3. Had major surgery (eg, requiring general anesthesia and hospitalization), within 8 weeks before screening, or will not have fully recovered from surgery, or has such 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. 4. Has a transplanted organ (with exception of a corneal transplant >12 weeks before the first administration of study intervention). 5. History of substance abuse or alcohol abuse within 1 year before screening. 6. Uncontrolled chronic disease that might require bursts of oral corticosteroids including co-morbid, severe, uncontrolled asthma (eg, history of >=2 asthma exacerbations within the last 12 months requiring systemic [oral and/or parenteral] corticosteroid treatment or hospitalization for >24 hours). 7. In the investigator’s opinion, any clinically significant results from the 12-lead ECG, chemistry, hematology, or urinalysis laboratory tests obtained at the screening visit that would affect interpretation of study data or the participant’s safety in the study. 8. History of chronic or recurrent infectious disease, including but not limited to chronic renal infection, chronic chest infection (eg, bronchiectasis, untreated latent tuberculosis), recurrent urinary tract infection (recurrent pyelonephritis or chronic non-remitting cystitis), fungal infection (mucocutaneous candidiasis), mycobacterial infection, or open, draining, or infected skin wounds, or ulcers. 9. Known or suspected immunodeficiency, including history of invasive opportunistic infections (eg, active TB, nontuberculous mycobacterial infection, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystis, aspergillosis, HIV) or otherwise recurrent infections of abnormal frequency or prolonged duration despite infection resolution, suggesting an immune-compromised status, as judged by the investigator. 10. Serious infection (eg, disseminated herpes zoster, sepsis, pneumonia, or pyelonephritis), or has been hospitalized or received IV antibiotics for an infection during the 8 weeks before screening. 11. Recent case of eczema herpeticum, herpes zoster, or impetigo within 8 weeks before screening or history of recurrent eczema herpeticum (2 or more in their lifetime) or impetigo. 12. Diagnosed active parasitic infection or at high risk of parasitic infection, unless treated with antihelminth therapy prior to randomization. 13. History of being HIV antibody-positive, HIV test positive, or tests positive for HIV at screening; 14. Tests positive for HBV or HCV infection at screening or known liver cirrhosis (see Section 10.8). 15. Current malignancy or history of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| EASI 75 at Week 12; | — |
Secondary
| Measure | Time frame |
|---|---|
| EASI 100 at Week 12;Percent change from baseline in PP-NRS at Week 12;vIGA-AD score of 0 and a reduction from baseline of >=2 points at Week 12;>=4-point improvement in PP-NRS from baseline through Week 12;Percent change from baseline in Skin Pain NRS at Week 12;Frequency and type of AEs and SAEs;vIGA-AD score of 0 or 1 and a reduction from baseline of >=2 points at Week 12;Percent change from baseline in EASI score at Week 12;EASI 90 at Week 12;Percent change from baseline in the score of Item 2 of the AD Sleep Scale at Week 12;The proportion of subjects whose skin Pain Digital Rating Scale (NRS) improved by >=4 points compared to the baseline at week 12;The proportion of subjects who achieved an eczema area and Severity Index (EASI) of 90 in response at week 12; | — |
Countries
China
Contacts
Public ContactCui Yong
China-Japan Friendship Hospital
Outcome results
None listed