A Phase 2 Study of ABBV-3067 Alone and in Combination With ABBV-2222

AbbVie

Status and phase: Completed; Phase 2

Conditions: Cystic Fibrosis

Treatments: Drug: ABBV-3067; Drug: Placebo ABBV-3067; Drug: ABBV-2222; Drug: Placebo ABBV-2222

Study type: Interventional

Funder types: Industry

Identifiers

NCT03969888

2019-000750-63 (EudraCT Number)

M19-530

Details and patient eligibility

About

This study will evaluate the safety, tolerability, and efficacy of ABBV-3067 given alone and in combination with various doses of ABBV-2222 in adults with Cystic Fibrosis who are homozygous for the F508del mutation.

Enrollment: 78 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Confirmed clinical diagnosis of Cystic Fibrosis (CF) who are homozygous for the F508del CF transmembrane conductance regulator (CFTR) mutation
• Stable pulmonary status
• Lung function >= 40 and <= 90% of predicted normal for age, gender and height at Screening

Exclusion criteria

• History of solid organ or hematopoietic transplant
• Cirrhosis with portal hypertension
• Use of CFTR modulator therapy within 60 days prior to Screening

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

78 participants in 8 patient groups, including a placebo group

ABBV-3067 50 mg + Placebo for ABBV-2222

Experimental group

Description:

Participants received ABBV-3067 50 mg tablet orally once daily (QD) plus placebo matching ABBV-2222 capsule, orally QD for 28 days.

Treatment:

Drug: ABBV-3067

Drug: Placebo ABBV-2222

ABBV-3067 150 mg + Placebo for ABBV-2222

Experimental group

Description:

Participants received ABBV-3067 150 mg tablet orally QD plus placebo matching ABBV-2222 capsule, orally QD for 28 days.

Treatment:

Drug: ABBV-3067

Drug: Placebo ABBV-2222

ABBV-3067 150 mg + ABBV-2222 10 mg

Experimental group

Description:

Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 10 mg capsule orally QD for 28 days.

Treatment:

Drug: ABBV-2222

Drug: ABBV-3067

ABBV-3067 150 mg + ABBV-2222 30 mg

Experimental group

Description:

Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 30 mg capsule orally QD for 28 days.

Treatment:

Drug: ABBV-2222

Drug: ABBV-3067

ABBV-3067 150 mg + ABBV-2222 100 mg

Experimental group

Description:

Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 100 mg capsule orally QD for 28 days.

Treatment:

Drug: ABBV-2222

Drug: ABBV-3067

ABBV-3067 150 mg + ABBV-2222 200 mg

Experimental group

Description:

Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 200 mg capsule, orally QD for 28 days.

Treatment:

Drug: ABBV-2222

Drug: ABBV-3067

ABBV-3067 150 mg + ABBV-2222 300 mg

Experimental group

Description:

Participants received ABBV-3067 150 mg tablet orally QD plus ABBV-2222 300 mg capsule, orally QD for 28 days.

Treatment:

Drug: ABBV-2222

Drug: ABBV-3067

Placebo for ABBV-3067 + Placebo for ABBV-2222

Placebo Comparator group

Description:

Participants received placebo matching ABBV-3067 tablet orally QD plus placebo matching ABBV-2222 capsule, orally QD for 28 days.

Treatment:

Drug: Placebo ABBV-3067

Drug: Placebo ABBV-2222