Atopic dermatitis MedDRA version: 21.1 Level: LLT Classification code 10003639 Term: Atopic dermatitis System Organ Class: 100000004858
Conditions
Sponsors
Dermira Inc. a wholly-owned subsidiary of Eli Lilly and Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Received treatment in a Dermira-sponsored lebrikizumab study, DRM06-AD04, DRM06-AD05, DRM06-AD06, DRM06-AD17 or DRM06-AD18 (parent trial) and have adequately completed the study treatments and last patient visit of the parent trial. 2. Willing and able to comply with all clinic visits and study-related procedures. 3. For women of childbearing potential: agree to remain abstinent (refrain from heterosexual intercourse) or use a highly effective contraceptive method during the treatment period and for at least 18 weeks after the last dose of lebrikizumab or placebo. NOTE: A woman of childbearing potential (WOCBP) is defined as a postmenarcheal female, who has not reached a postmenopausal state (= 12 continuous months of amenorrhea with no identified cause other than menopause) and has not undergone surgical sterilization (removal of ovaries and/or uterus). NOTE: The following are highly effective contraceptive methods: combined (estrogen and progestogen containing) hormonal contraception (oral, intravaginal, transdermal) associated with inhibition of ovulation, progestogen-only hormonal contraception (oral, injectable, implantable) associated with inhibition of ovulation, intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomized partner, or sexual abstinence. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception. 4. Male patients must agree to use an effective barrier method of contraception during the study and for a minimum of 18 weeks following the last dose of study drug if sexually active with a female of child-bearing potential. 5. Provide signed informed consent/assent as described in Section 10.2. Are the trial subjects under 18? yes Number of subjects for this age range: 100 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 700 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: 1. Patients who, during their participation in the parent trial, developed a serious adverse event (SAE) deemed related to lebrikizumab, which in the opinion of the investigator or Study Protocol: DRM06-AD07 Lebrikizumab of the medical monitor could indicate that continued treatment with lebrikizumab may present an unreasonable risk for the patient. 2. Patients who, during their participation in the parent trial, developed an AE that was deemed related to lebrikizumab and led to study treatment discontinuation, which in the opinion of the investigator or of the medical monitor could indicate that continued treatment with lebrikizumab may present an unreasonable risk for the patient. 3. Conditions in the previous parent study consistent with protocol-defined criteria for permanent study drug discontinuation, if deemed related to lebrikizumab or led to investigator - or sponsor-initiated withdrawal of patient from the study (e.g., noncompliance, inability to complete study assessments, etc.). 4. Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study. * Note for exclusion criteria # 1, 2, and 3: In studies that are still blinded, conditions deemed related to the study treatment will be considered related to lebrikizumab.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this study is to assess the long-term safety and efficacy of lebrikizumab in patients with moderate-to-severe AD.;Secondary Objective: Not Applicable;Primary end point(s): Describe the proportion of patients discontinued from study treatment due to adverse events through the last treatment visit.;Timepoint(s) of evaluation of this end point: Through the last treatment visit | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Proportion of patients with a response of IGA 0 or 1 • Proportion of patients achieving response of EASI-75 from baseline of parent study.;Timepoint(s) of evaluation of this end point: Over the duration of the study | — |
Countries
Australia, Bulgaria, Canada, Estonia, France, Germany, Korea, Republic of, Latvia, Lithuania, Mexico, Poland, Singapore, Spain, Taiwan, Ukraine, United States
Contacts
Public ContactClinical Trial Registry Office
Eli Lilly
Outcome results
None listed