Status:
COMPLETED
A Study of KY1005 in Patients With Moderate to Severe Atopic Dermatitis
Lead Sponsor:
Kymab Limited
Conditions:
Dermatitis, Atopic
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
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...
Detailed 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 diseas...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 13 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 8 2020
Estimated Enrollment :
89 Patients enrolled
Trial Details
Trial ID
NCT03754309
Start Date
December 13 2018
End Date
October 8 2020
Last Update
January 27 2023
Active Locations (19)
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1
Kymab investigational site 106
Kiel, Germany
2
Kymab investigational site 113
Leipzig, Germany
3
Kymab investigational site 207
Gdansk, Poland
4
Kymab investigational site 216
Katowice, Poland