The Effects of Tildrakizumab in Treatment of Bullous Pemphigoid

NCT04465292 | Unknown Early Phase 1 DMC FDA Drug

• 1 other identifier: 2020P000025
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is an open-label, pilot study evaluating the efficacy of tildrakizumab on the treatment of bullous pemphigoid (BP) in eligible patients (see detailed study protocol). Three total doses of tildrakizumab 100mg will be administered at Weeks 0, 4, 16 a total of 16 weeks of treatment by the study staff to patients with bullous pemphigoid. The patients will be followed for a total of 24 weeks.

Conditions

Pemphigoid, Bullous

Outcome Measures

Primary Outcomes (1)

• Change in Disease Severity

  Disease severity category (mild: 1-9 lesion(s), moderate: 10-30 lesions, and severe: \> 30

  Weeks 0, 4, 16, and 24

Secondary Outcomes (6)

• Change in Bullous Pemphigoid Disease Activity Index (BPDAI)

  Weeks 0, 4, 16, and 24

• Change in BPDAI-Pruritus

  Weeks 0, 4, 16, and 24

• Change in Dermatology Life Quality Index (DLQI)

  Weeks 0, 4, 16, and 24

• anti-BP180, BP230 IgG

  Weeks 0, 4, 16, and 24

• Total IgE

  Weeks 0, 4, 16, and 24

Study Arms (1)

Intervention

EXPERIMENTAL

Participants will receive Tildrakizumab 100mg at Weeks 0, 4, 16; three doses; a 16-week treatment course and 24-week followup

Drug: Tildrakizumab Prefilled Syringe

Interventions

Tildrakizumab Prefilled Syringe DRUG

Patients will receive Tildrakizumab 100 mg subcutaneously at Weeks 0, 4, and 16. The study staff will administer each dose.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years of age
• Diagnosis of diffuse bullous pemphigoid clinically and confirmed on H\&E, DIF +/- IIF/ELISA
• Able and willing to provide informed consent, participate in study visits, and undergo visit procedures

You may not qualify if:

• Unusual and localized variant of bullous pemphigoid will be excluded, these include but not limited to, BP sine rash, dyshidrosiform pemphigoid, pemphigoid vegetans, pemphigoid nodularis, lichen planus pemphigoid, pretibial BP, vulva BP, peristomal BP, umbilical BP, Brunsting-Perry, BP localized only to sites of injury, radiation, amputation, paralysis, or other underlying dermatosis.
• Prior tildrakizumab use.
• Treatment with a systemic immune-regulating nonsteroidal medication(s) within 6 weeks of the baseline visit, or use of systemic steroid within 2 weeks of baseline visit. Examples of systemic immune-regulating nonsteroidal medications include azathioprine, methotrexate, mycophenolate mofetil, cyclosporine, intravenous immunoglobulins, dapsone, colchicine, sulfasalazine, or omalizumab.
• Treatment with other biologic agents, such as TNF inhibitors, anti-IL17 agents, anti-IL12/23 agents, anti-IL4/13, anti-IL5, anti-IL23 agents or anti-eotaxin, within 4 months of baseline visit.
• Use of rituximab within at 6 months (or until lymphocyte counts by CD19 and CD20 have normalized if longer than 6 months) of the baseline visit.
• Concurrent use of any medication that may affect the efficacy of tildrakizumab.
• Use of belimumab within the past year (given tildrakizumab may enhance the adverse effect of belimumab)
• Other active conditions, such as psoriasis or contact dermatitis, that may confound clinical evaluations of dermatitis and patient-reported symptoms.
• Increased risk of infection or reactivated infection, including history of human immunodeficiency virus, hepatitis B, hepatitis C, endoparasitic infections, receipt of a live attenuated vaccine within 3 months of the baseline visit, chronic or acute infection requiring treatment within 4 weeks of the baseline visit, baseline immunodeficiency status otherwise nonspecified (i.e. history of recurrent or resistant infections)
• History of malignancy excluding local cutaneous squamous cell carcinoma, basal cell carcinoma or cervical carcinoma in situ that has been fully treated.
• Women who are or plan to become pregnant or breastfeed during study participation or are unable or not willing to use birth control during the study and for 4 months after the last dose of tildrakizumab. Options for birth control include abstinence, double barrier (i.e. male condom and female diaphragm), vasectomy, intrauterine device, and hormonal contraception. Females who have not had menses within 1 year of the baseline, bilateral tubal ligation, hysterectomy, and/or bilateral oophorectomy visit do not require additional methods contraception during study participation.
• Unstable condition or status, as per study investigator's judgment, that may lead to more likely discontinuation from the study including but not limited to major, recurrent medical illnesses that may require hospital admission and/or discontinuation of tildrakizumab, surgery that would require discontinuation of tildrakizumab and/or major rehabilitation, inability to participate in all study visits.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Joseph Merola: collaborator

MeSH Terms

Conditions

Pemphigoid, Bullous

Condition Hierarchy (Ancestors)

Skin Diseases, Vesiculobullous; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Liset Chacin

CONTACT

617-264-5926; lchacin@bwh.harvard.edu

Alex Gionfriddo

CONTACT

agiofriddo@bwh.harvard.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending physician

Study Record Dates

• First Submitted: May 14, 2020
• First Posted: July 10, 2020
• Study Start: September 1, 2020
• Primary Completion: December 1, 2022
• Study Completion: May 1, 2023
• Last Updated: July 10, 2020

Record last verified: 2020-07