EUCTR2021-000725-28-DEActive, not recruitingPhase 1
A Phase IIb, Randomised, Double Blind, Placebo Controlled, Parallel Group, Multicentre Dose Ranging Study of a Subcutaneous Anti-OX40L Monoclonal Antibody (KY1005) in Moderate to Severe Atopic Dermatitis (Study Testing Response Effect of KY1005 Against Moderate to Severe Atopic Dermatitis. The STREAM-AD Study) - Study Testing Response Effect of KY1005 Against Moderate to Severe Atopic Dermatitis (STREAM-AD)
Kymab Ltd, a Sanofi Company0 sites350 target enrollmentStarted: November 16, 2021Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 350
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Adults (18 to < 75 years of age) with AD for 1 year or longer at
- •Baseline (Day 1; prior to first administration of IMP).For United
- •Kingdom, see Section 17.15.2 (Appendix 15).
- •EASI of 12 or higher at the Screening Visit and 16 or higher at
- •IGA of 3 or 4 at Baseline.
- •AD involvement of 10% or more of BSA at Baseline.
- •Baseline worst/maximum pruritus NRS of = 4. The baseline weekly
- •average of daily worst/maximum pruritus NRS will be calculated from
- •the 7 consecutive days immediately preceding the Baseline visit.
- •Documented history, within 6 months prior to Baseline, of either
- •inadequate response or inadvisability of topical treatments.
- •Must have applied a stable dose of topical bland emollient (simple
- •moisturizer, no additives [e.g., urea]) at least twice daily for a minimum of 7 consecutive days before Baseline.
- •Able to complete patient questionnaires, including collection of NRS (pruritus) on each of the 7 days prior to Baseline. .
- •Able and willing to comply with requested study visits/telephone visits and procedures.
- •Able and willing to provide written informed consent. This document must also actually be presented at the time of inclusion.
- •For patients who decide to join the biopsy sub-study at sites selected for skin biopsy collection: be able and willing to provide skin biopsies at Baseline and Day113 (Week 16).
- •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 335
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
Exclusion Criteria
- •1.Treatment with any of the following prior to first IMP administration (Baseline):
- •Systemic corticosteroids, and systemic calcineurin inhibitors (tacrolimus and cyclosporin) within 4 weeks;
- •Leukotriene inhibitors within 4 weeks;
- •Systemic therapy for AD, including but not limited to methotrexate, cyclosporine, azathioprine, phosphodiesterase type 4 (PDE4)-inhibitors, IFN-? and mycophenolate mofetil within 4 weeks;
- •Targeted biologic and small molecule treatments within 5 half-lives or within 12 weeks prior to baseline, whichever is longer;
- •Previous treatment with systemic janus kinase (JAK)inhibitors at any
- •Topical corticosteroids, tacrolimus or pimecrolimus, or topical PDE4
- •within 7 days
- •Prescription or non-prescription moisturisers with additives (e.g.urea, filaggrin) within 2 weeks;
- •Phototherapy or allergen immunotherapy within 4 weeks
- •Regular use (>2visits/week) of a tanning booth/parlour within 4 weeks
- •Any prior use of anti OX40 or anti OX40L mAb; including KY1005.
- •Investigational therapy for the treatment of AD or other conditions
- •within 5 half-lives or the limit of PD effects or 12 weeks where the t1/2 is unknown.
- •2. Known history of, or suspected, significant current immunosuppression, including history of invasive opportunistic or
- •helminth infections despite infection resolution or otherwise recurrent infections of abnormal frequency or prolonged duration.
- •3. Weight <40 kg or>150 kg at Baseline.
- •4. Treatment with a live (attenuated) immunisation within 12 weeks
- •prior to Baseline; completion of required administrations of COVID-19 vaccine within 14 days prior to Baseline or within 14 days immediately prior to or following IMP administration.
- •5.Men and women (of reproductive potential) unwilling to use birth
- •control and women who are pregnant or breastfeeding.
- •6.Any malignancies or history of malignancies prior to Baseline(except for non-melanoma skin cancer that has been excised and cured for more than 3years prior to Baseline; in situ cervical carcinoma that has been excised and cured).
- •7.Positive for human immunodeficiency virus, hepatitis B surface
- •antigen, hepatitis B core antibody or hepatitis C antibody at the
- •Screening Visit.
- •8. History (within last 2 years prior to Baseline) of prescription drug or substance abuse, including alcohol, considered significant by the
- •Investigator.
- •9. Current or any past history of tuberculosis or non-tuberculous
- •mycobacterial infections (including a positive QuantiFERON®Tuberculosis Gold blood test at the Scr-Visit).
- •10.Elective surgery planned to be scheduled for any time in the period from Screening up to 12 weeks following the last dose of IMP that in the investigator's opinion would impact the conduct of the trial.
- •11.Anticipated initiation of prohibited medications from Screening up to 12 weeks following the last dose of IMP.
- •12.Severe concomitant illness that would in the Investigator's opinion
- •inhibit the patient's participation in the study, including for example,
- •but not limited to, hypertension, renal disease, neurological conditions, heart failure and pulmonary disease.
- •13.Skin comorbidity that would adversely affect the ability to undertake AD assessments.
- •14.Any medical or psychiatric condition which, in the opinion of the
- •investigator may present an unreasonable risk to the study patient as a result of his/her participation in this clinical study, may make patient's participation unreliable, or may interfere with study
- •assessments.
- •15.Any active or chronic
Investigators
Similar Trials
Active, not recruiting
Phase 1
A Subcutaneous Dose Ranging Study of KY1005 in Patients with Moderate to Severe Atopic DermatitisMedDRA version: 21.1Level: LLTClassification code 10003639Term: Atopic dermatitisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersAtopic dermatitisEUCTR2021-000725-28-PLKymab Ltd, a Sanofi Company350
Active, not recruiting
Phase 1
A Subcutaneous Dose Ranging Study of KY1005 in Patients with Moderate to Severe Atopic DermatitisAtopic dermatitisMedDRA version: 21.1Level: LLTClassification code 10003639Term: Atopic dermatitisSystem Organ Class: 100000004858EUCTR2021-000725-28-BGKymab Ltd, a Sanofi Company350
Active, not recruiting
Phase 1
A Subcutaneous Dose Ranging Study of KY1005 in Patients with Moderate to Severe Atopic DermatitisAtopic dermatitisEUCTR2021-000725-28-CZKymab Ltd, a Sanofi Company350
Active, not recruiting
Phase 1
A Subcutaneous Dose Ranging Study of KY1005 in Patients with Moderate to Severe Atopic DermatitisAtopic dermatitisMedDRA version: 21.1Level: LLTClassification code 10003639Term: Atopic dermatitisSystem Organ Class: 100000004858EUCTR2021-000725-28-ESKymab Limited350
Active, not recruiting
Phase 1
A Subcutaneous Dose Ranging Study of KY1005 in Patients with Moderate to Severe Atopic DermatitisMedDRA version: 21.1Level: LLTClassification code 10003639Term: Atopic dermatitisSystem Organ Class: 100000004858Atopic dermatitisEUCTR2021-000725-28-HUKymab Limited350