REZPEGALDESLEUKIN for Alopecia areata

Inclusion criteria

• {"criterion_text":"- Adults who are at least 18 years and ≤60 years for males (≤70 years of age for females) old at the time of informed consent\n- Diagnosis of Alopecia Areata (AA) severity at screening and baseline: 1. severe to very severe AA (≥ 50% scalp involvement) as measured using the SALT score. 2 Documented history over 6 months with no spontaneous improvement prior to baseline. 3 Current episode of severe to very severe AA of less than 8 years\n- Women of childbearing potential (WOCBP) must have a negative pregnancy test at screening and baseline.\n- While on investigational product and for at least 30 days after taking the last dose of investigational product (IP), WOCBP who engage in activity in which conception is possible must use approved highly effective contraceptive method(s). For male patient with partner that is WOCBP in which conception is possible, male patient must agree to use approved highly effective contraceptive method(s).\n- Able to complete patient questionnaires\n- Able and willing to comply with requested study visits and procedures\n- Able and willing to provide written informed consent\n- Able to communicate, read and/or understand the local language"}

Exclusion criteria

• {"criterion_text":"- Men and women (of reproductive potential) unwilling to use birth control and women who are pregnant or breastfeeding.\n- Patient has primarily “diffuse” type AA (characterized by diffuse hair shedding).\n- Presence of another form of alopecia.\n- Prior use of any of the following treatments: 1. aldesleukin 2. investigational IL-2 analog 3. oral Janus kinase (JAK) inhibitor for any indication, including, but not limited to, baricitinib, upadacitinib, abrocitinib, tofacitinib, and ruxolitinib, whether marketed or investigational 4. systemic immune-modulating biologic therapy (including, but not limited to, dupilumab, tralokinumab, lebrikizumab, nemolizumab, rocatinlimab, rituximab, ocrelizumab, ofatumumab, belimumab, daxdilimab, etc.) whether marketed or investigational\n- History of cancer or lymphoproliferative disease within 5 years prior to Day 1. Note: Patients with successfully treated nonmetastatic cutaneous squamous cell or basal cell carcinoma with no evidence of metastatic disease for 3 years and/or localized carcinoma in situ of the cervix with no evidence of recurrence within the 3 years prior to Day 1 are not to be excluded.\n- Current infection with human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus at screening.\n- Other skin conditions that would interfere with study assessments of AA"}

Primary endpoints

• {"endpoint_text":"- Percent change from baseline in Severity of Alopecia Tool (SALT) score at Week 36","definition_or_measurement_approach":"Percent change from baseline in SALT score assessed at baseline and at Week 36."}

Secondary endpoints

• {"endpoint_text":"- Percent change from baseline in SALT score at Weeks 12, 16, 20, 24, 28 and 32","definition_or_measurement_approach":"Percent change from baseline in SALT score assessed at the specified weeks."}
• {"endpoint_text":"- Proportion of patients achieving improvement in SALT (≥50%, ≥75%, and ≥90%) relative to their baseline score (SALT50, SALT75 and SALT90) at Weeks 12, 16, 20, 24, 28, 32, and 36","definition_or_measurement_approach":"Proportion of patients meeting the specified percent-improvement thresholds (SALT50/SALT75/SALT90) at the listed assessment weeks compared with baseline."}
• {"endpoint_text":"- Proportion of patients achieving an absolute SALT score ≤10, ≤20, ≤30, ≤50 relative to their baseline score at Weeks 12, 16, 20, 24, 28, 32, and 36","definition_or_measurement_approach":"Proportion of patients achieving specified absolute SALT score cutoffs at listed weeks compared with baseline."}

Methods

• Advertisement Document (K1_Recruitment arrangements_PL_Advertisement Document) — Poland
• Doctor to Patient Letter (K1_Recruitment arrangements_PL_Doctor to Patient Letter) — Poland
• Physician to Physician Letter (K1_Recruitment arrangements_PL_Physician to Physician Letter) — Poland
• Patient Brochure (K1_Recruitment arrangements_PL_Patient Brochure) — Poland
• Recruitment Poster (K1_Recruitment arrangements_PL_Recruitment Poster) — Poland
• General recruitment arrangements document K1_Recruitment arrangements_PL (Poland)

Poland

Earliest CTIS Part Ii Submission Date

16-10-2024

Latest Decision Or Authorization Date

12-09-2025

Processing Time Days

331

Number Of Sites

14

Number Of Participants

38

Primary sponsor

Full Name

Nektar Therapeutics

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

PPD Development Ireland Limited

Name

Medpace Inc.

Name

WCG Clinical Inc.

Responsibilities

Investigator training

Third parties

• {"country":"United States","full_name":"Canfield Scientific Inc.","duties_or_roles":"Photography rental and SALT assessments training, certification, and licensing fee","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"Investigator training","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"PCI","duties_or_roles":"","organisation_type":"Industry"}
• {"country":"United States","full_name":"Scarritt Group Inc.","duties_or_roles":"Investigator meeting planner","organisation_type":"Non-Pharmaceutical company"}
• {"country":"France","full_name":"Quipment","duties_or_roles":"study supplies","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Q Squared Solutions LLC","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"Ireland","full_name":"PPD Development Ireland Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Sherpa Clinical Packaging LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Transperfect Translations International Inc.","duties_or_roles":"eTMF","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Veeva Systems Inc.","duties_or_roles":"RTSM","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"Patient reimbursement","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"United States","full_name":"Medpace Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"PCI Pharma Services Germany GmbH","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
• {"country":"Canada","full_name":"Innovaderm Research Inc.","duties_or_roles":"multiple sponsor duties (codes present)","organisation_type":"Pharmaceutical company"}
• {"country":"Belgium","full_name":"MEDPACE LABORATORIES","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"Italy","full_name":"Patheon Italia S.p.A.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Medrio Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}