Subjects with generalized pustular psoriasis MedDRA version: 20.0 Level: PT Classification code 10037575 Term: Pustular psoriasis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Product Code: ANB019
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: anti-IL-36R monoclonal antibody
Current Sponsor code: ANB019
Concentration unit: mg/ml milligram(s)/millilitre
Conc
Sponsors
AnaptysBio Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Male and female subject aged 18 to 80 years (inclusive) at the time of signing the informed consent. 2.Subject has a known and documented history of GPP as per the European Rare and Severe Psoriasis Expert Network GPP criteria confirmed by the Investigator based on review of medical records and/or medical history OR subject is experiencing his/her first episode of GPP at the initial Screening, in which case the GPP diagnosis must be confirmed by the Investigator. -Subjects can enter Screening regardless of their current GPP severity. Subject may have a GPP flare of moderate to severe intensity defined by a BSA affected with pustules (excluding palms and soles)=5%, a GPPPGA score=3 (moderate severity), and a PRS score=3 (moderate severity) at the initial screening visit OR subject may have a GPPPGA score= (mild severity) and/or a PRS score= 2mild severity) and/or BSA affected with pustules (excluding palms and soles) 40 kg. 6.Subject has no clinically significant medical condition or physical/laboratory/ECG/vital signs abnormality that would, in the opinion of the Investigator, put the subject at undue risk or interfere with interpretation of study results. 7.Subject meets the following tuberculosis (TB) screening criteria: a)Has no history of latent or active TB before Screening. An exception is made for subjects who have a history of latent TB and i) are currently receiving treatment for latent TB and will continue or complete treatment during study participation, ii) will initiate treatment for latent TB before the first administration of study drug and will continue treatment during study participation, iii) or have completed appropriate treatment for latent TB before the first administration of study drug. NOTE: It is the responsibility of the Investigator to verify and document the adequacy of concurrent or previous anti-TB treatment based on current local TB treatment guidelines. b) Have no signs or symptoms suggestive of active TB upon medical history and/or physical examination. c) Have had no recent close contact with a person with active TB, based on information provided by the subject. d) Have a negative QuantiFERON®-TB test result obtained during Screening prior to Day 1. NOTE: However, a QuantiFERON®-TB test is not required at Screening for subjects with a known history of latent TB who have previously completed, plan to initiate, or are currently receiving appropriate TB treatment as described above in Inclusion Criterion 7a. NOTE: Subjects with a newly identified positive QuantiFERON®-TB Screening test result must undergo an evaluation to rule out active TB and initiate appropriate treatment for latent TB prior to the first administration of study drug. Appropriate treatment for latent TB is defined according to current local guidelines. 8.Subject has the report from a qualified r
Exclusion criteria
Exclusion criteria: 1.Subject has other form of psoriasis ,except plaque psoriasis not previously described. 2.Subject has an immediately life-threatening flare of GPP in the Investigator’s opinion or requires treatment in an intensive care unit.Life-threatening complications include, but are not limited to,cardiovascular/cytokine-driven shock, pulmonary distress syndrome or renal failure. 3.Subject has concomitant dermatological or medical conditions that may interfere with the Investigators’ ability to evaluate the subject’s response to therapy. 4.Subject has a positive blood screen for hepatitis C antibody and hepatitis C ribonucleic acid (RNA),an exclusionary hepatitis B blood screen profile (defined in Appendix 20), or human immunodeficiency virus 1 or 2 antibodies. 5.Subject has a history of clinically significant cardiac, pulmonary, neurologic, gastrointestinal, endocrine, hematological, renal, hepatic, cerebral, autoimmune, or psychiatric disease, or other major uncontrolled disease, which puts the subject at undue risk for participation. 6.Subject has a history of chronic or recurrent infectious disease, including but not limited to upper and lower respiratory infection ,urinary tract infection. 7.Subject has a history or any evidence of an active bacterial, viral, or fungal infection (has signs and/or symptoms of the infection and/or received antibiotic, antiviral, or antifungal therapy for it) within 14 days prior to Day 1. 8.Subject has any factors that would predispose the subject to develop an infection in the Investigator’s opinion 9.Subject has a history of an opportunistic infection or parasitic infections within 3 months prior to Day 1. 10.Subject has a history of a herpes zoster infection within 2 months prior to Day 1. 11.Subject has any history of known or suspected congenital or acquired immunodeficiency state, or condition that would compromise the subject’s immune status 12.Subject had any major surgery within 4 weeks of Day 1. 13.Subject has a history of cancer or lymphoproliferative disease within 5 years prior to Day 1. Subjects with successfully treated nonmetastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix are not to be excluded. 14.Subject has a history of any significant drug allergy or reaction to imsidolimab, polysorbate-20, any other component or excipient (inactive ingredient) of the imsidolimab formulation. 15.Prior treatment with imsidolimab, or other anti-IL-36R antibody. 16.For subjects with prior use of the following GPP therapies or procedures, the specified washouts located in the Protocol between last dose of prohibited medication and Day 1 will apply 17. Receipt of any live or live-attenuated vaccines within 12 weeks of Day 1. -Nonlive and nonlive-attenuated vaccines for COVID-19 are allowed during the study. 18. Subject has a known history of clinically significant drug or alcohol abuse in the last year prior to Day 1, or other factors limiting the ability to cooperate and to comply with the study protocol, as determined by the Investigator. 19. Subject is a pregnant or lactating woman, or a woman who intends to become pregnant during the study period. 20. Subject is not able to tolerate IV drug administration. 21. A subject who meets any of the following criteria will not be allowed to participate in biopsy collection, but may still be eligible for the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of imsidolimab compared with placebo in subjects with GPP flare ;Secondary Objective: To assess the safety of imsidolimab in subjects with GPP flare;Primary end point(s): Proportion of subjects achieving a GPPPGA score of 0 (clear) or 1 (almost clear) at Week 4;Timepoint(s) of evaluation of this end point: Week 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Key Secondary Efficacy Endpoint: • Proportion of subjects achieving a PRS score of 0 (clear) or 1 (almost clear) at Week 1 Additional Secondary Efficacy Endpoints: • Proportion of subjects achieving at least a 2-grade decrease from Baseline in GPPPGA score at Week 4 • Proportion of subjects achieving clinical response on the CGI scale at Week 4. Clinical response is defined as “Very much improved,” “Much improved,” and “Minimally improved” on the CGI scale according to the mJDA severity index total score • Change from Baseline in BSA affected with erythema with pustules as assessed by the mJDA severity index at Week 1 • Percent change from Baseline in BSA affected with erythema with pustules as assessed by the mJDA severity index at Week 1 Change from Baseline in BSA affected with erythema with pustules as assessed by the mJDA severity index at Week 4 • Percent change from Baseline in BSA affected with erythema with pustules as assessed by the mJDA severity index at Week 4 • Change from Baseline in BSA affected with total erythema as assessed by the mJDA severity index at Week 4 • Percent change from Baseline in BSA affected with total erythema as assessed by the mJDA severity index at Week 4 • Change from Baseline in BSA affected with edema as assessed by the mJDA severity index at Week 4 • Percent change from Baseline in BSA affected with edema as assessed by the mJDA severity index at Week 4 • Proportion of subjects achieving an improvement of 50% from Baseline in GPPASI (GPPASI 50) at Week 4 • Proportion of subjects achieving an improvement of 75% from Baseline in GPPASI (GPPASI 75) at Week 4 • Change from Baseline in DLQI at Week 4 • Change from Baseline in EQ-5D-5L at Week 4 • Proportion of subjects with at least a 3-point decrease from Baseline in pain NRS at Week 4 for subjects with a Baseline pain NRS of at least 3;Timepoint(s) of evaluation of this end point: Week 4 | — |
Countries
Australia, France, Georgia, Germany, Korea, Republic of, Malaysia, Poland, Romania, Spain, Taiwan, Thailand, United States
Contacts
Public ContactAnaptysBio Clinical Trials Info
AnaptysBio Inc.
Outcome results
None listed