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
Sponsors
AnaptysBio Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject participated in the preceding placebo-controlled Phase 3 study ANB019-301, and 1) completed at least the Week 1 visit of the ANB019-301 study without the use of rescue/prohibited medication for GPP and needed rescue medication starting at Week 1 or later during the ANB019-301 study, or 2) completed the Week 4 visit of the ANB019-301 study, and did not need or use rescue/prohibited medication for GPP during his or her entire participation in the ANB019-301 study. NOTE: Subjects who did not need rescue/prohibited medication for GPP during their participation in the ANB019-301 study will not be eligible for this study if they did not complete the Week 4 visit of the ANB019-301 study. 2. Subject must be a candidate for prolonged GPP treatment according to the Investigator’s judgment. 3. 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. 4. Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Contraception and pregnancy: a) A male subject who is sexually active with a female of childbearing potential and has not had a vasectomy must agree to use contraception as detailed in Appendix 1 of this protocol during the treatment period and for at least 220 days (which includes the duration of relevant exposure plus the duration of sperm cycle) after the last study treatment administration and refrain from donating sperm during this period. b) Female subjects: i) A woman of childbearing potential (WOCBP) is eligible to participate if she has a negative urine pregnancy test at Day 1is not breastfeeding, and if heterosexually active agrees to follow the contraceptive guidance during the treatment period and for at least 6 months after receiving the study treatment, and refrains from donating oocytes for assisted reproduction during this period. The female subject’s selected form of contraception must be effective by the time the female subject enters into the study at Day 1 (eg, hormonal contraception should be initiated at least 28 days before Day 1). ii) A woman not of childbearing potential as defined in Appendix 1, must have a follicle-stimulating hormone (FSH) test confirming nonchildbearing potential. Follicle-stimulating hormone testing is not required as part of the present study if already performed in the preceding study (data is available on file) and confirmed nonchildbearing potential. NOTE: If a female participant’s childbearing potential changes after start of the study (eg, a woman who is not heterosexually active becomes heterosexually active, a premenarchal woman experiences menarche), she must begin practicing a highly effective method of birth control, as described above. 5. Subject is willing to participate and is capable of giving written informed consent, which must be personally signed and dated by the subject and obtained prior to any study-related activities. 6. Subject must be willing to comply with all study procedures and must be available for the duration of the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 35 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this a
Exclusion criteria
Exclusion criteria: 1. The following drugs or procedures are prohibited between the last visit of the ANB019-301 study and the Day 1 visit of the ANB019-302 study (if scheduled on separate days): a) Imsidolimab, or other anti-IL-36R antibody. b) Any topical with active ingredients that could have an effect on GPP (including, but not limited to: corticosteroids, retinoids, vitamin A or D analog preparations, tacrolimus, calcineurin inhibitor, topical H1 and H2 antihistamines, tar preparations, topical antimicrobials, other medicated topical agents). c) Any conventional systemic treatments that could have an effect on GPP (including, but not limited to, corticosteroids [eg, oral, IV, intramuscular], retinoids [eg, acitretin, alitretinoin], methotrexate, cyclosporin, fumaric acid esters, or any other immunosuppressant or immunomodulation drugs). NOTE: Intranasal corticosteroids and inhaled corticosteroids are allowed. Eye and ear drops containing corticosteroids are also allowed. d) Any ultraviolet B (UV-B) phototherapy (including tanning beds), excimer laser, or psoralen and ultraviolet A (PUVA) treatment. e) Any nonbiologic investigational drug. f) Marketed or investigational biological agent. g) Live and live-attenuated vaccines. NOTE: Nonlive and nonlive-attenuated vaccines for COVID-19 (eg, ribonucleic acid (RNA)-based vaccines, protein-based vaccines, and nonreplicating viral vector-based vaccines) are allowed during the study. 2. Subject has any factor limiting the ability to cooperate and to comply with the study protocol, as determined by the Investigator. 3. Subject is a pregnant or lactating woman, or a woman who intends to become pregnant during the study period. 4. Subject has any other physical, mental, or medical conditions, which, in the opinion of the Investigator, make study participation inadvisable or could confound study assessments. 5. Subject is not able to tolerate IV and/or SC drug administration.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the long-term safety of imsidolimab in subjects with GPP who have participated in the ANB019-301 study ;Secondary Objective: To evaluate the long-term efficacy of imsidolimab in subjects with GPP who have participated in the ANB019-301 study;Primary end point(s): Incidence of AEs, SAEs, and AEs leading to withdrawals, as well as changes in vital signs, clinical laboratory parameters (hematology, biochemistry, and urinalysis), and 12-lead ECGs ;Timepoint(s) of evaluation of this end point: Week 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Proportion of subjects with zero recurrence of GPP flare (defined by a GPPPGA = 3 [moderate] in subjects who had previously achieved a GPPPGA score of 0 [clear] or 1 [almost clear]) through Week 24 • Proportion of subjects in remission (defined by a GPPPGA score of 0 [clear] or 1 [almost clear]) at Week 24, without intake of any rescue medications during the treatment period • Time to first GPP flare recurrence • Proportion of subjects with a GPPPGA score of 0 (clear) or 1 (almost clear) at Week 24 • Proportion of subjects with a PRS score of 0 (clear) or 1 (almost clear) at Week 24 • Time to first pustulation flare recurrence (defined by a PRS = 3 [moderate] in subjects who had previously achieved a PRS score of 0 [clear] or 1 [almost clear]) • Proportion of subjects with a clinical response on the CGI scale at Week 24. Clinical response is defined as "Very much improved," "Much improved," and "Minimally improved" on CGI scale according to the mJDA severity index total score • Proportion of subjects losing clinical response on the CGI scale (defined as subjects who had previously achieved clinical response defined as "minimally improved" or better on CGI scale according to the mJDA severity index total score and worsen to either "no change" or "worsened" on the CGI scale) at Week 24 • Change from Baseline in BSA affected with erythema with pustules as assessed by the mJDA severity index at Week 24 • Percent change from Baseline in BSA affected with erythema with pustules as assessed by the mJDA severity index at Week 24 • Change from Baseline in BSA affected with total erythema as assessed by the mJDA severity index at Week 24 • Percent change from Baseline in BSA affected with total erythema as assessed by the mJDA severity index at Week 24;Timepoint(s) of evaluation of this end point: Week 24 | — |
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