Download “A Double-Blinded Randomized, Placebo

Xtend-CIU (Xolair Treatment Efficacy of Longer Duration in Chronic Idiopathic Urticaria):
A Phase IV, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to
Evaluate the Efficacy & Safety of Omalizumab through 48 Weeks in Patients with
Chronic Idiopathic Urticaria
Sherwin Gillman, MD / Brooke Bottrell, CCRC
GENENTECH – ML29510 Xtend
STUDY OBJECTIVE: To evaluate the level of control of CIU symptoms through 48 weeks, among patients continuing
Xolair as compared to those receiving placebo after an initial 24 weeks of Xolair treatment.
INCLUSION CRITERIA:
1. 12-75 years of age. Females must not be pregnant or nursing & all must use acceptable method of contraception
(hormonal, surgical or double-barrier) except those meeting the post-menopausal criteria. (see exclusion criteria).
2. Diagnosis of CIU refractory to H1 antihistamines at baseline, defined by:
a) presence of itch & hives for >8 consecutive weeks at any time before enrollment despite use of > 4x approved dose.
b) UAS7 score > 16 & itch component of > 8 during 7 days prior to baseline.
c) in-clinic UAS > 4 on at least one of the screening days (visits 1,2,3)
d) must have been on H1 antihistamines for CIU at least 3 consecutive days prior to screen & document current use.
e) CIU diagnosis >6 months. (Patient reporting okay)
3. No missing diary entries in the 7 days prior to baseline.
EXCLUSION CRITERIA:
1. Body weight < 20 kg (44 lbs.)
2. Clearly defined underlying etiology for chronic urticarias other than CIU.
3. Evidence of parasitic infection.
4. Atopic dermatitis, bullous pemphigold, dermatitis herpetiformis, senile pruritus, or other skin diseases with itch.
5. Previous treatment with Xolair within 1 year.
6. Current, history or suspected malignancy except non-melanoma skin cancer treated or excised & considered resolved.
7. History of anaphylactic shock.
8. Clinically significant cardiovascular, neurological, phychiatric, metabolic, or any conditions that would interfer.
9. Current drug or alcohol abuse.
ALLOWED MEDICATIONS:
1. Oral contraceptives & hormone-replacement therapy.
2. Long-acting H1 antihistamines, up to 4 x dose.
3. Leukotrienes.
4. Diphenhydramine 25 mg up to 3 x day.
5. Asthma controller medications, including ICS.
6. H2 blockers.
7. Oral steroids <5 days.
DISALLOWED MEDICATIONS:
1. Routine or > 10 consecutive days of systemic steroids, hydroxychloroquine, methotrexate, mycophenolate,
cyclosporine or cyclophosphamide.
2. Doxepin.
3. Xolair within 1 year.
4. IVIG or plasmapheresis within 30 days.
PATIENT COMPENSATION: $80.00 per visit (OL-$880.00; DB-$800.00; Transition-$560.00)
Genentech.Doc
Dell 5/7/2017