A Study of KY1005 in Patients With Moderate to Severe Atopic Dermatitis

Kymab

Status and phase: Completed; Phase 2

Conditions: Dermatitis, Atopic

Treatments: Drug: KY1005; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03754309

ACT17369 (Other Identifier)

KY1005-CT02

2018-002299-41 (EudraCT Number)

Details and patient eligibility

About

The purpose of this research study is to investigate if KY1005 results in improvement of eczema when given to participants with moderate to severe disease. Side effects of KY1005 will also be explored.

Full description

Phase 2a, randomized, double-blinded, placebo-controlled study to evaluate the efficacy, safety and tolerability of two doses of KY1005 in adults with moderate to severe atopic dermatitis whose disease cannot be adequately controlled with topical medications or for whom topical treatment is medically inadvisable.

Enrollment: 89 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults (greater than or equal to [>=] 18 years but less than [<] 75 years of age) with Atopic Dermatitis (AD) for 1 year or longer at Baseline (Day 1; prior to first administration of Investigational Medicinal Product [IMP]).
• Eczema Area and Severity Index (EASI) of 12 or higher at the Screening Visit and 16 or higher at Baseline.
• validated Investigator Global Assessment (vIGA) of 3 or 4 at Baseline.
• AD involvement of 10 percent or more of body surface area at Baseline.
• Documented history, within 6 months prior to Baseline, of either inadequate response to topical treatments 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 at least 7 consecutive days before Baseline.
• Able and willing to comply with requested study visits/telephone visits and procedures.
• Able and willing to provide punch biopsy of both lesional and non-lesional skin at Baseline.
• Able and willing to provide written informed consent.

Exclusion criteria

• Recent treatment within specific time windows before the baseline visit for the management of atopic dermatitis such as topical or systemic corticosteroids, biologic or investigational therapies and/or phototherapy.
• Known history of or suspected significant current immunosuppression, including history of invasive opportunistic infections despite infection resolution or otherwise recurrent infections of abnormal frequency or prolonged duration.
• Basal and squamous cell skin cancer in the last 3 years prior to Baseline. Any other malignancies in the last 5 years prior to Baseline (excluding in situ cervical carcinoma).
• Severe concomitant illness that would in the Investigator's opinion inhibit the participant's participation in the study, including for example, but not limited to, renal disease, neurological conditions, heart failure and pulmonary disease.
• Laboratory values at the Screening Visit:
• a. Serum creatinine > 1.6 milligrams per deciliter (mg/dL) (141 micromole per liter [mcmol/L]) in female participants and > 1.9 mg/dL (168 mcmol/L) in male participants;
• b. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 1.5 × upper limit of normal (ULN);
• c. Platelet count < 100*10^9/L;
• d. Haemoglobin (Hb): Male < 13.5 g/dL and Female <12 g/dL;
• e. White blood cell count (WBCC) < 3.0*10^9/L;
• f. Absolute neutrophil count < 2.0*10^9/L;
• g. Absolute lymphocyte count < 0.5*10^9/L;
• h. Total bilirubin > ULN.
• Participation in any other clinical study, including non-interventional studies.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

89 participants in 3 patient groups, including a placebo group

KY1005 lower dose

Experimental group

Description:

Low dose KY1005

Treatment:

Drug: KY1005

KY1005 higher dose

Experimental group

Description:

High dose KY1005

Treatment:

Drug: KY1005

Placebo

Placebo Comparator group

Description:

Matched placebo

Treatment:

Drug: Placebo